Use of mobile fitness app to improve pelvic floor muscle training in puerperal women with gestational diabetes mellitus: a randomized controlled trial

doi:10.21203/rs.3.rs-3770691/v1

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Research Article

Use of mobile fitness app to improve pelvic floor muscle training in puerperal women with gestational diabetes mellitus: a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-3770691/v1

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Background

Gestational diabetes mellitus (GDM) is a risk factor for postpartum urinary incontinence. Pelvic floor muscle training (PFMT) improves pelvic floor dysfunction in puerperal women, but patient compliance is low. Mobile Health(mHealth)is a promising solution.

Objective

To investigate PFMT compliance and effects on pelvic floor muscles in GDM puerperal women guided by the mobile fitness app KEEP.

Methods

This randomized controlled trial included puerperal women with GDM (n = 72) who were delivered at a tertiary general hospital, selected from November 2021 to April 2022 using convenience sampling, and randomly divided into control (n = 36) and experimental (n = 36) groups. The control group performed PFMT based on routine postpartum PFMT training instruction. The experimental group performed PFMT based on KEEP. Both groups had a 4-week intervention period. The PFMT compliance, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Pelvic Muscle Self-efficacy Scale, and the Knowledge, Attitude, Belief, and Practice (KAP) scores of PFMT in puerperal women in the groups were compared pre- and post-intervention. Pelvic floor surface electromyographic biofeedback was used to compare the post-intervention pelvic floor muscle strength between the two groups.

Results

Compared with the control group, the test group had higher post-intervention maternal PFMT compliance, pelvic floor muscle strength, pelvic floor muscle self-efficacy, and KAP scores (p < 0.05); incontinence scores were lower (p < 0.05). Pelvic floor muscles in both groups recovered better post-intervention (p < 0.05).

Conclusion

The KEEP app can improve PFMT adherence, urinary incontinence, KAP scores, self-efficacy, and pelvic floor muscle strength in GDM puerperal women and promote pelvic floor rehabilitation after delivery.

Gestational diabetes mellitus

Rehabilitation

Postpartum

Pelvic Floor Disorders

Patient Compliance

Mobile Applications

Gestational diabetes mellitus (GDM), an abnormality of glucose tolerance because of insufficient insulin secretion occurring for the first time during pregnancy, is one of the most common pregnancy complications.^[1] In recent years, as the prevalence of obesity and number of women of advanced maternal age have risen globally, the incidence of GDM has gradually increased, resulting in a serious economic burden on public health care institutions.^[2]

Studies have shown that GDM is a high-risk factor for pelvic floor disorders (PFD) in women.^{[3, 4]} More than one-fourth of women with GDM may experience postpartum urinary incontinence, surpassing both the incidence and severity observed in non-GDM mothers.^[5] This is because pregnant women with GDM tend to experience excessive gestational weight gain and a higher incidence of fetal macrosomia, leading to increased pelvic pressure compared to healthy pregnant women. In addition, GDM is associated with autonomic dysfunction, which affects the innervation of the bladder musculature or urethral sphincter, resulting in voiding dysfunction.^{[6, 7]} In the crucial early postpartum period, essential for pelvic floor muscle repair, PFMT can effectively increase muscle strength, thus reducing the incidence of PFD-related diseases. PFMT involves the patient's conscious active contraction of the pelvic floor muscles, mainly the pubic and coccygeal muscle groups.^[8] The majority of recent studies focus on pregnant or laboring women with normal blood glucose levels. In a study conducted by Temtanakitpaisan et al., out of 110 pregnant women surveyed, only 50% were familiar with PFMT, and among them, only 10.7% practiced PFMT during pregnancy.^[9] Furthermore, Kari et al. conducted a follow-up study involving nearly 20,000 women, revealing that only 27.6% consistently performed PFMT more than 3 times per week within 6 months of delivery.^[10] In another study by Heidi et al., only 31% of women were willing to participate in PFMT, 41% were hesitant, and 15% showed no interest at all.^[11] Thus, maternal adherence to PFMT is notably low. The efficacy of PFMT relies heavily on patient compliance.^{[12, 13]} Therefore, it is imperative that we identify interventions that can enhance maternal adherence to PFMT, as such interventions have the potential to positively affect their pelvic floor rehabilitation and, consequently, enhance the overall quality of life.

The World Health Organization defines Mobile Health (mHealth) as the promotion of patient health by providing information on healthcare services and health literacy through mobile communication technologies, such as smartphones, tablets, and other wireless mobile devices.^[3] Due to its many advantages, mHealth is a promising solution. In recent years, extensive studies have been conducted in the realm of app-based audio and other features guidance for PFMT. The findings of these studies revealed significant improvements in stress incontinence, self-efficacy, and quality of life compared to those of traditional home PFMT.^[14–16] However, assessments of PFMT adherence are less common, and no studies on GDM are available. In addition, most studies have focused on the end of puerperium or even 6 months postpartum. In contrast, KEEP, an exercise app widely accepted by young people, enables PFMT in mothers with GDM. In this randomized controlled trial, we hypothesized that puerperal women with GDM might benefit from PFMT guided by KEEP. Therefore, we investigated the compliance and effect of this software on PFMT for women with GDM, which could provide a reference for healthcare institutions to provide pelvic floor rehabilitation for patients with GDM.

2.1 Study design

In this randomized controlled trial, we employed the convenience sampling method to select women diagnosed with GDM who were delivering in the obstetrics department of a tertiary general hospital from November 2021 to April 2022. Participants were randomly divided into the control and experimental groups, with each group comprising 36 patients. We investigated the impact of using the mobile fitness app KEEP on the adherence to PFMT and rehabilitation of the pelvic floor muscles of puerperal women with GDM.

2.2 Research participants

The inclusion criteria were as follows: ① pregnant women at 24–28 weeks of pregnancy who were diagnosed with GDM according to the diagnostic criteria of The International Association of Diabetes and Pregnancy Study Groups (IADPSG), i.e., administration of a 75 g oral glucose tolerance test (OGTT)^[17] resulting in a fasting blood glucose (FBG) level ≥ 5.1 and < 7.0 mmol/L, 1-h postprandial blood glucose (PBG) level ≥ 10.0 mmol/L, or 2-h PBG level ≥ 8.5 and < 11.1 mmol/L; ② singleton pregnancy; ③ age ≥ 18 years old; ④ vaginal delivery; ⑤ ability to use the KEEP app; and ⑥ signed informed consent and voluntary participation. The exclusion criteria were as follows: ① patients with a history of pelvic organ prolapse or pelvic surgery prior to pregnancy who required long-term PFMT; ② patients using KEEP to perform PFMT prior to inclusion in the study; ③ those with severe organ dysfunction; and ④ those with cognitive impairment.

The study participants were systematically grouped according to a random number table. An impartial non-participant employed a computer program to generate randomized number sequence, which was then meticulously placed in sequentially coded, sealed, and opaque envelopes. Finally, both the experimental and control groups comprised 36 cases each.

2.3 Sample size calculation

The number of research participants was designed according to the equal sample size of two groups. In this study, the main observation index, the PFMT adherence, was used for the sample size estimation, and the significance level α was set to 0.05. Based on the study by Yuan et al.^[18] for sample size estimation, 29 cases were required for each group. Accounting for a 20% potential loss to follow-up, 36 cases were needed in each group, and the final total sample size was 72 cases.

2.4 Interventions

The measures used in the experimental group included routine postpartum care. The perineum was disinfected with povidone-iodine twice daily during hospitalization, and mothers were instructed to pay attention to perineal hygiene after discharge to promote wound healing. Mothers with an episiotomy were instructed to lie on the healthy side. Maintaining a balanced diet was advocated to avoid constipation. Mothers were instructed to exercise appropriately to avoid venous thrombosis. Breastfeeding was encouraged, and breastfeeding instructions were provided. The key step was that the researcher instructed the study participants to download and master the use of the mobile fitness app KEEP, including learning PFMT-related knowledge, taking courses, and joining the baby moms' exchange station, which was conducive to the PFMT exercise clock and interactive communication among women with GDM during the puerperium. Mothers were instructed to watch the "Kegel Training" video and complete the training punch card once to confirm mastery of the material. Women were instructed to follow the training video and perform PFMT every day starting at 2 weeks postpartum. They were told to lie down on the bed or floor during PFMT and not perform any other strenuous exercise to ensure their safety.

The control group were instructed to use the same routine postpartum care as the experimental group. The researcher instructed the control group to perform the PFMT training recommended in the guidelines for the diagnosis and treatment of female stress urinary incontinence (SUI),^[19] i.e., the same training movements as those of the KEEP app in the experimental group, allowing the patients to complete PFMT at home. The exercises were as follows: for 15 min, the pelvic floor muscles were continuously contracted for no less than 3 s, relaxed and rested for 2–6 s, and the process was repeated 3 times a day or 150–200 anal contractions were performed every day. The training data of the two groups were collected and recorded by researchers.

2.5 Evaluation tools and data collection

Demographic and disease information was obtained from the medical records of the study participants. Questionnaires on compliance with PFMT; urinary incontinence; knowledge, beliefs and needs for PFMT; and self-efficacy of PFMT were completed in the 2nd and 6th postpartum weeks, and the pelvic floor muscle strength was measured using a pelvic floor surface electromyography biofeedback device in the 6th postpartum week. Importantly, all data collectors were kept uninformed about the grouping of patients to maintain objectivity and prevent potential bias.

2.5.1 PFMT compliance

The PFMT adherence questionnaire, designed by Chen and Tzeng, was used to evaluate the PFMT adherence before and after the intervention in both groups.^[20] The questionnaire has a Cronbach's alpha coefficient of 0.81 and can be used to describe the daily PFMT activity of the mothers, including the average time spent on PFMT every day, the average number of PFMT contractions per session, and the visual analog scale of PFMT adherence. Numbers from 0 to 10 were selected to best reflect adherence. The total score of the questionnaire ranged from 2–21. The higher the score, the better the compliance.

2.5.2 Pelvic floor muscle strength

The deep and superficial muscle layers of puerperal women with GDM were evaluated for muscle strength by the same pelvic floor rehabilitator at the 6th week postpartum. Electrodiagnostics were performed using a pelvic floor surface electromyographic biofeedback instrument to measure the pelvic floor muscle strength. The pelvic floor muscle function was assessed using the Glazer method with the following criteria: anterior and posterior resting phases of 2–4 uV, with > 4 uV indicating overactive pelvic floor muscles; 5 rapid contraction phases of 35–45 uV, with < 35 uV indicating decreased fast muscle (class II fibers) strength; 10 s sustained contraction phases of 30–40 uV, with < 30 uV indicating decreased slow muscle (class I fibers) strength; and a 60 s sustained contraction phase of 25–35 uV, with < 25 uV indicating decreased slow muscle endurance. ^[21]

2.5.3 Urinary incontinence and quality of life

The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) was used to assess maternal urinary incontinence and its impact on quality of life in both groups before and after the intervention. The questionnaire included frequency of urinary leakage (0–5 points), amount of urinary leakage (0–6 points), and impact of incontinence on quality of life (0–10 points), as well as self-diagnosis of the causes of incontinence. The severity of urinary incontinence was categorized into three grades based on the total score: ≤7, mild; 8–13, moderate; and 14–21, severe.^[22]

2.5.4 Knowledge and demand for pelvic floor muscle function training for puerperal women

The questionnaire developed by Zhang et al. was used to evaluate the PFMT knowledge, beliefs, behaviors, and needs in puerperal women. ^[23]The Cronbach's alpha coefficient of the questionnaire was 0.928, the retest reliability was 0.916, the overall split reliability was 0.922, and the content validity was 0.933. The questionnaire consisted of 4 dimensions and 39 items. With a possible total score of 71, scores > 60 were good, scores ≥ 42 and ≤ 60 were fair, and scores < 42 were poor. The questionnaire contained 18 entries on knowledge of pelvic floor muscle function exercise, 8 entries on attitudes and beliefs, 6 entries on behaviors, and 7 entries on knowledge sources and needs.

2.5.5 PFMT self-efficacy

The PFMT self-efficacy scale by Bai et al. was used to assess the confidence and competence in PFMT before and after the intervention in both groups^[24]. The scale, which included expected self-efficacy (14 entries) and expected outcomes (9 entries), had a Cronbach's alpha coefficient of 0.912; the Cronbach's alpha coefficients of the expected self-efficacy and expected outcomes dimensions were 0.845 and 0.941, respectively. The retest reliabilities of the total scale, expected self-efficacy dimension, and expected outcome dimension were 0.910, 0.841, and 0.935, respectively. Total scores > 70, 50–70, and < 50 indicated high, moderate, and poor self-efficacy, respectively.

2.6 Statistical analysis

All data were tested for normality. If the data were normally distributed and met the chi-square test, two-sample t-tests were used to analyze the between-group differences in age, body mass index at birth, weight gain during pregnancy, newborn weight, and scores on each scale. Count data (educational level, maternal history, and perineal wound status) were expressed as numbers and percentages, and differences between groups were analyzed using the χ² test. The nonparametric Mann-Whitney U test was used if data had a non-normal distribution. For all tests, p-values < 0.05 indicated statistically significant differences.

A total of 72 patients were included in this study, including 36 each in the control and experimental groups, and all study participants completed the 4-week intervention without missing any visits or dropping out(see Fig. 1:Flow Diagram). Notably, there were no reported instances of discomfort during the intervention in either group.

3.1 Comparison of maternal general and disease information before intervention

The maternal general and disease information were not significantly different between the two groups before the intervention (p > 0.05) (Table 1).

Table 1

Comparison of maternal general and disease information between the two groups
Item	Control group (n = 36)	Test group (n = 36)	t or χ²-value	P-value
Age (years)	30.23 ± 3.56	30.33 ± 2.86	0.168^a	0.867
BMI at delivery (kg/m²)	23.81 ± 2.22	24.14 ± 2.43	0.602^a	0.549
Weight gain during pregnancy (kg)	15.01 ± 3.32	15.47 ± 3.02	0.615^a	0.541
Education level
College degree or lower	6	4	0.469^b	0.791
College degree	11	12
Bachelor’s degree or higher	19	20
Pregnancy history
Primipara	15	17	0.225^b	0.635
Multipara	21	19	0.225^b	0.635
Neonatal weight (kg)	3.31 ± 0.78	3.08 ± 0.61	1.394^a	0.168
Perineal wound condition
Lateral incision	18	17	0.229^b	0.892
Laceration (I° or II°)	16	16	0.229^b	0.892
Data are presented as \(\stackrel{-}{x}\pm s\).
^a denotes t-values
^b denotes χ²-values.

3.2 Comparison of maternal PFMT adherence scores before and after intervention

Before the intervention, the maternal PFMT adherence scores between the two groups were not significantly different (p > 0.05). After the intervention, the scores of both groups were significantly higher (p < 0.05), and the experimental group had a higher score than that of the control group (p < 0.05) (Table 2).

Table 2

Comparison of PFMT compliance scores between the test and control groups before and after the intervention
Group	Cases	PFMT compliance score		t-value	p-value
Group	Cases	Pre-intervention	Post-intervention	t-value	p-value
Control group	36	10.24 ± 4.17	11.76 ± 1.54	2.894	0.012
Test group	36	10.36 ± 4.32	14.68 ± 2.56	3.671	0.000
t-value		1.135	5.848
p-value		0.399	0.000
Data are presented as \(\stackrel{-}{x}\pm s\).

3.3 Comparison of maternal ICIQ-SF scores before and after intervention

The ICIQ-SF scores of the two groups before the intervention were not significantly different (p > 0.05). After the intervention, the ICIQ-SF scores of both groups decreased (p < 0.001), but the score of the experimental group was lower than that of the control group (p < 0.05) (Table 3).

Table 3

Comparison of ICIQ-SF scores between the test and control groups before and after the intervention
Group	Cases	ICIQ-SF score		t-value	p-value
Group	Cases	Pre-intervention	Post-intervention	t-value	p-value
Control group	36	12.66 ± 1.74	7.83 ± 0.81	15.099	< 0.001
Test group	36	12.58 ± 1.68	5.28 ± 0.62	24.459	< 0.001
t-value		0.198	14.999
p-value		0.843	< 0.001
Data are presented as \(\stackrel{-}{x}\pm s\).
ICIQ-SF, International Consultation on Incontinence Questionnaire Short Form

3.4 Comparison of maternal self-efficacy scores before and after intervention

The maternal self-efficacy between the two groups before the intervention was not significantly different (p > 0.05). After the intervention, the maternal self-efficacy scores of both groups increased (p < 0.001), and the score of the experimental group was higher than that of the control group (p < 0.001) (Table 4).

Table 4

Comparison of self-efficacy scores between the test and control groups before and after the intervention
Group	Cases	Self-efficacy score		t-value	p-value
Group	Cases	Pre-intervention	Post-intervention	t-value	p-value
Control group	36	48.52 ± 5.21	65.11 ± 6.86	11.749	< 0.001
Test group	36	48.87 ± 5.14	87.48 ± 9.23	21.977	< 0.001
t-value		0.287	11.671
p-value		0.775	< 0.001
Data are presented as \(\stackrel{-}{x}\pm s\).

3.5 Comparison of maternal PFMT Knowledge, Attitude, Belief, and Practice (KAP) scores before and after intervention

The KAP scores of maternal PFMT in the two groups before intervention were not significantly different (p > 0.05). After the intervention, the KAP scores of PFMT were higher in both groups (p < 0.001), but the scores in the experimental group were higher than those in the control group (p < 0.001) (Table 5).

Table 5

Comparison of KAP scores in PFMT between the test and control groups before and after the intervention
Group	Cases	KAP score		t-value	p-value
Group	Cases	Pre-intervention	Post-intervention	t-value	p-value
Control group	36	44.42 ± 0.53	52.64 ± 5.38	9.123	< 0.001
Test group	36	44.33 ± 0.48	66.43 ± 6.72	19.681	< 0.001
t-value		0.755	9.612
p-value		0.453	< 0.001
Data are presented as \(\stackrel{-}{x}\pm s\).
KAP, knowledge attitude practice; PFMT, pelvic floor muscle training

3.6 Comparison of maternal pelvic floor muscle strength after intervention

After the intervention, the maternal pelvic floor class I and II muscle strengths of the test group were significantly higher than those of the control group (p < 0.001) (Table 6).

Table 6

Comparison of pelvic floor muscle strength between the test and control groups after the intervention
Group	Cases	Type I muscle strength	Type II muscle strength
Control group	36	1.10 ± 0.21	1.04 ± 0.19
Test group	36	2.88 ± 0.35	2.54 ± 0.31
t-value		26.166	24.753
p-value		< 0.001	< 0.001
Data are presented as \(\stackrel{-}{x}\pm s\).

4.1 App-based PFMT improves maternal adherence of women with GDM

The results of this study show that KEEP-based PFMT can improve maternal compliance. Traditional pelvic floor muscle rehabilitation training mainly relies on the guidance of healthcare personnel and at-home training by the mothers, whereas the KEEP app can attract the interest of mothers through diverse forms, such as video, audio, and animation, and provide interactive guidance, supervision, and education, thus improving adherence to PFMT. Studies have found that only 10.7% of pregnant women perform PFMT during pregnancy, and only half of them recognize PFMT. Thus, guidance and education on PFMT and the ability to maintain motivation for adherence are critical,^[9] and finding ways to promote maternal adherence to PFMT is important. This study provides an approach that can be used. Borello et al.^[25] followed up 146 women at 3, 6, and 12 months postpartum for adherence and showed that maternal adherence to PFMT declines over time, because the women often forget to train. Most mothers perform PFMT at home, and they often forget to train because they are busy with life and work and lack timely training reminders. Mobile fitness apps such as KEEP are easy to use and can be used at home to remind mothers to perform PFMT daily, which can help with pelvic floor rehabilitation. In addition, a study of women at 3 months postpartum showed that the cost of the program is one of the factors affecting their adherence to PFMT;^[11] the KEEP app used in this study is free, interactive, and practical, which may influence women’s willingness to participate and adhere to a PFMT program and provide a useful method to improve pelvic floor rehabilitation. In the future, studies of user characteristics and preferences for usage modes should be conducted to further improve the functions of the app.

4.2 App-based PFMT improves urinary incontinence in mothers with GDM

The results of this study showed that both groups had moderate maternal incontinence before the intervention that became mild after the intervention, with a greater improvement in the experimental group than in the control group. SUI occurs during pregnancy because of pregnancy-related hormonal changes, such as increased luteinizing hormone, decreased relaxin, and decreased collagen levels. In addition, the increased pressure on the pelvic floor muscles from the growing uterus and fetal weight may result in decreased pelvic floor muscle strength and sphincter function, which can contribute to SUI development. Urinary incontinence affects the quality of life in terms of physical activity, travel, social relationships and emotional well-being in approximately 54.3% of pregnant women.^[3] A risk factor for SUI is GDM.^{[26, 27]} Studies have confirmed the ameliorative effects of PFMT in preventing SUI during pregnancy and the postpartum period, including the frequency, amount of urine leakage, and perceived severity of SUI.^{[28, 29]} However, most previous studies have been conducted in women with normal blood glucose, and studies of women with GDM are lacking. The results of this study suggest that using the mobile fitness app KEEP for PFMT in puerperal women with GDM can effectively improve maternal urinary incontinence, which adds to the research evidence on pelvic floor rehabilitation in GDM. Health professionals should inform and advise women to perform PFMT promptly to reduce further aggravation of postpartum SUI. Moreover, the app used in this study is cost-effective and may provide motivation for the exercise, making it suitable for real-world application, and improving adherence directly affects the degree of urinary incontinence improvement.^[20]

4.3 App-based PFMT improves self-efficacy of women with GDM

The results of this study showed that maternal self-efficacy for PFMT was higher in both groups after the intervention than before the intervention and was higher in the experimental group than in the control group after the intervention. A study assessing the role of self-efficacy in adherence to PFMT for prevention of urinary incontinence in postmenopausal women found decreased self-efficacy levels over time, which demonstrates the importance of self-efficacy in sustained behavioral change.^[30] Chen and Tzeng^[20] found that self-efficacy in incontinent mothers directly affects and is a significant predictor of adherence to PFMT. Another study identified a positive correlation between self-efficacy and adherence to behavioral interventions.^[30] The higher the patient’s self-efficacy, the higher their adherence to the healthcare provider’s instructions and medical advice in terms of attitudes and behaviors.^[31] However, to date, evidence on self-efficacy and adherence to PFMT behavioral programs for women with GDM is lacking. The results of the present study suggest that app-based PFMT can increase maternal self-efficacy in puerperal women with GDM, which may promote increased maternal PFMT adherence. Self-efficacy may mediate maternal attitudes toward PFMT and perceived benefits, which influence adherence to the exercise program. Therefore, self-efficacy may serve as an indicator for nurses to tailor exercise training programs for puerperal women with GDM to increase adherence to PFMT.

4.4 App-based PFMT improves the KAP level of women with GDM

The results of this study showed that the total post-intervention PFMT KAP scores of both groups were higher than the pre-intervention scores, and the scores of the experimental group were higher than those of the control group after the intervention. Most KAP surveys on PFMT in pregnant women have been cross-sectional; only 27.9% of women answered all questions about PFMT correctly, and only 10.7% of women performed PFMT regularly during pregnancy.^[9] In 2022, a randomized controlled trial(RCT) pilot study trained pregnant women with urinary incontinence in PFMT based on the mHealth app and found that the pregnant women’s knowledge and attitudes improved and their self-efficacy and exercise adherence were enhanced.^[16] Hence, there is a potential interplay between self-efficacy, KAP, and adherence as suggested by existing literature.^[32] However, research specifically focusing on this interplay in the context of GDM is currently lacking. In the Knowledge-Belief-Behavior theory, knowledge is the foundation, belief is the motivation, and behavior is the goal. Our results verified the improvement effect of the KEEP app on KAP in mothers with GDM. KEEP can motivate mothers to adhere to PFMT by providing knowledge related to pelvic floor rehabilitation and other mothers’ successful pelvic floor rehabilitation experiences. After mothers receive theoretical knowledge, they may be motivated to adopt correct behaviors by forming a deeper understanding, which will stimulate strong beliefs about wanting to change and improve their PFMT adherence, thus promoting the rehabilitation of pelvic floor muscle function.

4.5 App-based PFMT improves pelvic floor muscle strength in women with GDM

In recent years, pelvic floor function screening in women with GDM has utilized pelvic floor surface electromyography (EMG) assessments to more directly reflect the condition of the maternal pelvic floor muscles. Electrodes are placed on the vaginal wall surface of the mother and connected to a signal processing system to show the action potential of the superficial muscles as amplitude changes, as well as through biofeedback.^[33] Although PFMT with EMG biofeedback has been studied in women with urinary incontinence,^[33] women with GDM have not been studied. In this study, we found that after the intervention, the maternal pelvic floor class I and II muscle strengths of the experimental group were higher than those of the control group, which proved the effectiveness of PFMT based on the KEEP app for puerperal women with GDM. Pelvic floor muscles are divided into class I and II muscle fibers. Class I muscle fibers, the main component, are slow-contracting fibers that are capable of tonic contraction, are not easily fatigued, and can maintain sustained tension. Class II muscle fibers are fast-contracting fibers that are capable of phasic contraction, are easily fatigued, and mainly maintain reflex and voluntary contractions.^[34] In the technology acceptance model, the two main factors affecting user acceptance of information technology are the perceived ease of use and usefulness, which are the gold standard in healthcare technology applications and affect the user’s intention to continue using the application.^[35] Perceived usefulness is the most common predictor of mHealth use and shows a moderately strong relationship with perceived ease of use. The KEEP app used in this study has a simple and interactive design that attracts maternal use. For the participants in this study, KEEP was easy to use and accessible, and the app deserves further utilization.

4.6 Limitations and future research directions

The PFMT in this study was based on the guidance of the KEEP app, which focused on all women who need pelvic floor rehabilitation exercises and lacked GDM-specific disease care knowledge. Application software specifically designed for mothers with GDM is unavailable and should be developed in the future. In addition, this study was conducted in a single hospital, and a multicenter randomized controlled study should be conducted in the future to expand the sample size. Moreover, the intervention period of this study was only 4 weeks and should be extended in the future to examine long-term effects. Furthermore, previous studies have used the same incontinence scale as the present study to allow patients to self-assess, which may be subjective; therefore, portable instruments could be used in the future to allow home measurements. Finally, qualitative interviews with the study participants should be conducted to identify facilitating and hindering factors in the use of the KEEP app and improve the corresponding functional modules to promote its application.

This study verified the role of the mobile fitness app KEEP in the adherence to PFMT and pelvic floor rehabilitation in puerperal women with GDM, providing valuable evidence for healthcare organizations to provide pelvic floor rehabilitation to women with GDM. The long-term effects of the KEEP app-based PFMT intervention on pelvic floor rehabilitation should be followed up in the future.

Clinical Messages

We examined fitness app-guided postpartum pelvic floor muscle training (PFMT) in puerperal women with gestational diabetes mellitus (GDM).
To our knowledge, this is the first app-based PFMT study in puerperal women with GDM.
Using the KEEP app improves PFMT compliance and promotes pelvic floor rehabilitation in postpartum women with GDM.

Acknowledgements

We would like to thank the participation of research subjects, our supervisor for her guidance with this thesis and Editage (https://www.editage.com) for English language editing.

Author Contributions

XH and YX designed the research study, collected and analyzed the data, and wrote the manuscript. BX, MZ, HZ, and XZ collected and analyzed the data. HZ provided supervision and guidance. All authors contributed to editorial changes in the manuscript. All authors read and approved the final manuscript.

Declaration of Conflicting Interests

The authors declare no conflict of interest.

Funding

This work was supported by the Startup Fund for Scientific Research, Fujian Medical University (Grant number: 2022QH1119) and Fujian Provincial Key Clinical Specialties Construction Project in 2022 (The Second Affiliated Hospital of Fujian Medical University Key Discipline Special Project, Grant number: HLZDZK202301).

a.Ethics approval and consent to participate

All experiments were performed in accordance with the guidelines and regulations of Helsinki. Written informed consent was obtained from the study participants, and the study was approved prior to implementation by the Ethics Committee of the Second Affiliated Hospital of Fujian Medical University, where the investigators were located (approval number: 2021; Ethical review no. 210; approval date: May 23, 2021).

b. Consent for publication

Not applicable.

c. Availability of data and materials

The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.

Practice Bulletin No. 180 Summary: Gestational Diabetes Mellitus. Obstet Gynecol. 2017;130:244–6.
Zhu Y, Zhang C. Prevalence of Gestational Diabetes and Risk of Progression to Type 2 Diabetes: a Global Perspective. Curr Diab Rep. 2016;16:7.
Sangsawang B. Risk factors for the development of stress urinary incontinence during pregnancy in primigravidae: a review of the literature. Eur J Obstet Gynecol Reprod Biol. 2014;178:27–34.
Kim C, McEwen LN, Sarma AV, et al. Stress urinary incontinence in women with a history of gestational diabetes mellitus. J Womens Health (Larchmt). 2008;17:783–92.
Chuang CM, Lin IF, Horng HC, et al. The impact of gestational diabetes mellitus on postpartum urinary incontinence: a longitudinal cohort study on singleton pregnancies. BJOG. 2012;119:1334–43.
Price N, Dawood R, Jackson SR. Pelvic floor exercise for urinary incontinence: a systematic literature review. Maturitas. 2010;67:309–15.
Saadia Z. Urinary Problems Amongst Gynecological Consultations. Association Between Prolapse, Gynecological Surgery and Diabetes. Med Arch. 2015;69:315–8.
Kegel AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948;56:238–48.
Temtanakitpaisan T, Bunyavejchevin S, Buppasiri P, et al. Knowledge, Attitude, and Practices (KAP) Survey Towards Pelvic Floor Muscle Training (PFMT) Among Pregnant Women. Int J Womens Health. 2020;12:295–9.
Bø K, Owe KM, Nystad W. Which women do pelvic floor muscle exercises six months' postpartum? Am J Obstet Gynecol. 2007;197:49e1–5.
Moosdorff-Steinhauser HFA, Albers-Heittner P, Weemhoff M, et al. Factors influencing postpartum women's willingness to participate in a preventive pelvic floor muscle training program: a web-based survey. Eur J Obstet Gynecol Reprod Biol. 2015;195:182–7.
Davidson T, McDonald A, McPherson G, et al. A comparison of an objective and subjective test of stress urinary incontinence (SUI) and their acceptability to participants. Trials. 2015;16:P58.
Nambiar AK, Bosch R, Cruz F, et al. EAU Guidelines on Assessment and Nonsurgical Management of Urinary Incontinence. Eur Urol. 2018;73:596–609.
Chen L, Zhang D, Li T, et al. Effect of a Mobile App-Based Urinary Incontinence Self-Management Intervention Among Pregnant Women in China: Pragmatic Randomized Controlled Trial. J Med Internet Res. 2023;25:e43528.
Wang X, Xu X, Luo J, et al. Effect of app-based audio guidance pelvic floor muscle training on treatment of stress urinary incontinence in primiparas: A randomized controlled trial. Int J Nurs Stud. 2020;104:103527.
Jaffar A, Mohd Sidik S, Foo CN, et al. Preliminary Effectiveness of mHealth App-Based Pelvic Floor Muscle Training among Pregnant Women to Improve Their Exercise Adherence: A Pilot Randomised Control Trial. Int J Environ Res Public Health. 2022;19:2332.
International Association of Diabetes and Pregnancy Study Groups Consensus panel, Metzger BE, Gabbe SG, et al. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010;33:676–82.
Yuan R, Liu L. Practice of improving maternal adherence to perinatal pelvic floor muscle exercise [J]. China Nurs Manage. 2018;18(11):4.
Gynecologic Pelvic Floor Group of the Chinese Medical Association Obstetrics and Gynecology Section. Guidelines for the diagnosis and treatment of female stress urinary incontinence (2017) [J]. Chin J Obstet Gynecol. 2017;52(5):5.
Chen SY, Tzeng YL. Path analysis for adherence to pelvic floor muscle exercise among women with urinary incontinence. J Nurs Res. 2009;17:83–92.
Wang C-H, Ye Q-H. Optimizing the clinical care of an electrical stimulation biofeedback protocol for the treatment of mixed urinary incontinence [J]. J Nurse Advancement. 2018;33(17):3.
Huang L, Le MA, Deng X, Chinese version of the International Consultative Committee on Incontinence Questionnaire (ICIQ). : a useful tool for clinical diagnosis, treatment and research of urinary incontinence[C]//The First Global Chinese Academic Conference on Obstetrics and Gynecology and the Third National Academic Conference of Young and Middle-aged Physicians in Obstetrics and Gynecology of the Chinese Medical Association.
Zhang M, Xiao Q, Wu Y. A survey on the knowledge, belief and demand for pelvic floor muscle exercise in puerperal women [J]. Chin J Mod Nurs. 2017;23(30):8.
Bai X, Su F, Li H. Reliability and validity of the Chinese version of the Pelvic Floor Muscle Exercise Self-Efficacy Scale [J]. Chin Family Med. 2015;18(15):4.
Borello-France D, Burgio KL, Goode PS, et al. Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors. Phys Ther. 2013;93:757–73.
Diez-Itza I, Arrue M, Ibañez L, et al. Postpartum impairment of pelvic floor muscle function: factors involved and association with prolapse. Int Urogynecol J. 2011;22:1505–11.
Zhu L, Li L, Lang JH, et al. Prevalence and risk factors for peri- and postpartum urinary incontinence in primiparous women in China: a prospective longitudinal study. Int Urogynecol J. 2012;23:563–72.
Kocaöz S, Eroğlu K, Sivaslıoğlu AA. Role of pelvic floor muscle exercises in the prevention of stress urinary incontinence during pregnancy and the postpartum period. Gynecol Obstet Invest. 2013;75:34–40.
Sangsawang B, Sangsawang N. Is a 6-week supervised pelvic floor muscle exercise program effective in preventing stress urinary incontinence in late pregnancy in primigravid women? a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016;197:103–10.
Messer KL, Hines SH, Raghunathan TE, et al. Self-efficacy as a predictor to PFMT adherence in a prevention of urinary incontinence clinical trial. Health Educ Behav. 2007;34:942–52.
Kaşıkçı MK. Using self-efficacy theory to educate a patient with chronic obstructive pulmonary disease: A case study of 1-year follow-up. Int J Nurs Pract. 2011;17:1–8.
Mori A, Kakiuchi M, Matsumoto E, et al. Ingenuity for enabling the habituation of pelvic floor muscle training. J Phys Ther Sci. 2017;29:1287–91.
Hagen S, Elders A, Stratton S, et al. Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial. BMJ. 2020;371:m3719.
Huang J, Ding Y, Cheng M. Effects of health education and pelvic floor muscle training on postpartum pelvic floor dysfunction[J]. China Clin Med. 2016;23(1):92–4.
David FD. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Q. 1989;13:319–40.

No competing interests reported.

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Use of mobile fitness app to improve pelvic floor muscle training in puerperal women with gestational diabetes mellitus: a randomized controlled trial

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Abstract

Background

Objective

Methods

Results

Conclusion

Figures

1 Introduction

2 Methods

2.1 Study design

2.2 Research participants

2.3 Sample size calculation

2.4 Interventions

2.5 Evaluation tools and data collection

2.5.1 PFMT compliance

2.5.2 Pelvic floor muscle strength

2.5.3 Urinary incontinence and quality of life

2.5.4 Knowledge and demand for pelvic floor muscle function training for puerperal women

2.5.5 PFMT self-efficacy

2.6 Statistical analysis

3 Results

3.1 Comparison of maternal general and disease information before intervention

3.2 Comparison of maternal PFMT adherence scores before and after intervention

3.3 Comparison of maternal ICIQ-SF scores before and after intervention

3.4 Comparison of maternal self-efficacy scores before and after intervention

3.5 Comparison of maternal PFMT Knowledge, Attitude, Belief, and Practice (KAP) scores before and after intervention

3.6 Comparison of maternal pelvic floor muscle strength after intervention

4 Discussion

4.1 App-based PFMT improves maternal adherence of women with GDM

4.2 App-based PFMT improves urinary incontinence in mothers with GDM

4.3 App-based PFMT improves self-efficacy of women with GDM

4.4 App-based PFMT improves the KAP level of women with GDM

4.5 App-based PFMT improves pelvic floor muscle strength in women with GDM

4.6 Limitations and future research directions

5 Conclusion

Declarations

References

Additional Declarations

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