The effective of Otago Exercise Program on the physical frailty，cognitive function and ADL of elderly with cognitive frailty living in Nursing Homes: a randomized control trial

Abstract

Introduction:Cognitive frailty can affect elderly in multiple domian which including poor quality of life, dementia, disability even death. Timely intervention may become the main target for primary prevention. This study was to assess the effectiveness of group OEP program for elderly with cognitive frailty.

Method:This study was conducted from July 2020 to October 2020. Participants were elderly aged 75-95 years old who lived in nursing homes. Individuals in the study were randomly assigned to Otago Exercise Program(OEP) group (n = 31) and control group (n = 31). Besides sleep and diet-related health education, The intervetion in the OEP gourp consisted of 30-min session, twice a week and 12-week group exercise programme. The physical frailty, cognitive function and activities of daily living(ADL) were used to assess.

Results:After intervention, the mean score (SD) of frailty scores in the OEP group VS control group at T1 was (2.03 (0.81)) vs (1.41 (0.98)); At T2 was (2.00 (0.96)) vs (1.17 (1.00)).The mean score (SD) of MOCA scores in the OEP group VS control group at T1 was ( 22.17 (2.99)) vs (20.30 (2.96)); At T2 was (23.45 (3.66) ) vs (19.90 (3.25)). But group effect (p < 0.05) and the interaction effect (p < 0.05) was significant which indicated that the group effects on the frailty score and MOCA score change from baseline differed significantly over time. However, there was no significant group and interaction effect (P>0.05) of ADL scores between the intervention groups.

Conclusion:12-week OEP had better outcomes with respect to physical frailty and cognitive function for cognitive frailty elderly,but no effective on ADL.Further studies may also be able to find the OEP scheme on improving ADL.

Trial registration: The study was registered in the Chinese Ethics Clinical Trials Registry ( Registration Number - ChiCTR2000039592- Date of Registration 02/11/2020. Accessed on http://www.chictr.org.cn/index.aspx)

Introduction

According to the statistics,65 years or older people were 8.5% of the global population and this will be increasing to 16.7% by 2050[1].Ageing is accompanied by deterioration of multiple bodily functions and inflammation, which collectively contribute to frailty[2].As while,ageing population’s rapid expansion has brought a concomitant number of the frailty elderly rise meanwhile pressure on health-care systems worldwide will be increasing[3, 4].

Frailty is a complex age-related health state,and physiological capacity declined across organ systems, with a resultant increased susceptibility to stressors.Frailty includes physical frailty,cognitive frailty,and social frailty.Many reports focus on that physical frailty is closely associated with cognitive impairment[5, 6].And in 2013,“cognitive frailty” was proposed by the International Academy of Nutrition and Aging and the International Association of Gerontology and Geriatrics as a heterogeneous clinical manifestation characterized by the simultaneous presence of both physical frailty and mild cognitive impairment(MCI), but excluding Alzheimer's dementia or other dementias[7].

The prevalence of cognitive frailty has been reported between 0.72% and 50.1% because of different assessment tools and individuals[5, 8, 9]. And that in nursing homes has been reported as 26.2%[10].An epidemiologic population-based study found that cognitive frailty was a risk factor for poor quality of life, dementia, disability even death[11].Evidence exists that individuals with cognitive frailty had the highest risks of the activities of daily living(ADL) limitations[12]. Meanwhile several studies have shown that functional disabilities of frailty are associated with poor quality of life[13].Fortunately, frailty is a pathological aging process that is reversible[14], timely intervention may achieve better outcomes, and it has become the main target for primary prevention[15].

Therefore, effective strategies that target the prevention and management of frailty are needed,such as pharmaceuticals or nutraceuticals[16],and exercise[17].A progressive exercise beginning with flexibility and balancing training, followed by resistance and endurance training has shown to be effective in the elderly[18].In fact, the most recent updated American College of Sports Medicine guidelines recommend that resistance and balance training should precede for the elderly[19].Many authors acknowledge that physical activity has a positive impact on the functional performance of elderly individuals[16, 20].

A previous study showed that resistance exercise training was an effective strategy for cognitive frailty[21]. The Otago exercise programme (OEP) was originally designed as a home-based, supervised, progressive balance and muscle-strengthening programme for the elderly[22]. Benefits of the OEP contain reducing falls by improving balance, strength and cognitive function[23, 24]. However, very few studies have directly evaluated the impact of OEP for those with cognitive frailty elderly on frailty itself[25].

The main aim of this research was to assess the physical frailty,cognitive function and ADL of 12 weeks group OEP among the elderly with cognitive frailty who were living in nursing homes in China.

We hypothesize that:(1) there would be significant differences in physical frailty,cognitive function and ADL among individuals who received the OEP intervention after 12 weeks; and(2) the level of the physical frailty,cognitive function and ADL would be higher in the intervention group after 12 weeks than in the control group.

Materials And Methods

Trial design

Our study was a parallel-group, assessor-blind randomised controlled trial (RCT) for 12 weeks from July 2020 to October 2020 in a nursing home.The study had two groups:group 1,control (usual care)group;group 2, experimental (OEP) group. Control group received usual care, including health education and basic exercise,while participants in the OEP group received 12-week group OEP training for 30 min per session, three sessions per week. The study was registered in the Chinese Ethics Clinical Trials Registry ( Registration Number - ChiCTR2000039592- Date of Registration 02/11/2020. Accessed on http://www.chictr.org.cn/index.aspx). 

Participants

The study was conducted in two groups randomly selected from a nursing home for elderly people suffering from cognitive frailty in Changsha,China.Participants who were eligible for the trial were required to comply with the following criteria:age,≥75 years;Fried scores≥1[14];the Beijing version of the Montreal Cognitive Assessment (MOCA-BJ) scale score ranged 19–25[26];able to perform OEP as determined by a physiotherapist;resident in the nursing home for more than 3 months; literate; and willing to participate.The exclusion criteria were: suffering severe diseases, such as paralysis, severe heart disease, or fractures,and participating in another clinical exercise study;Participate in other exercise intervention.

Interventions

An active interventions were received for both groups for 12 weeks in total.The same interventions in two groups included 30 min of health education at least once a month covering exercise knowledge,the benefit of exercise, recommendations of physical activity for older people, and how to exercise scientifically, based on a Chinese exercise book. In addition, we provided sleep- and diet-related information.Before and after each workout, participants’ vital signs were monitored,which were contains blood pressure,heart rate,temperature, and oxyhemoglobin saturation. If the oxyhemoglobin saturation was lower than 90%,the blood pressure was lower than 90/60 mmHg or higher than 140/90 mmHg,Participant was required to stop the exercise and called a doctor for treatment[27].

The subjects were randomly assigned to one of the two groups:

Group 1,control (usual care)group: The programme included health education and the elements of active.participants were asked to maintain their regular activity habits and requested not to receive another intervention exercise programme during the study period.

Group 2, experimental (OEP) group:In addition to sleep- and diet-related information as the control group, we provide 12 weeks of group OEP training, with a frequency of three sessions a week at 30 min per session.

The OEP were performed the following scheme:5 min warm-up, 10 min resistance training and 15 min balance exercise.The OEP was guided by a physiotherapist who had rich experience with the elderly. Each movement had different levels, and different requirements. 5 min warm-up included head and neck exercise, body warm-up, and ankle warm-up. 10 min resistance training included knee extensors, knee flexors and hip abductors (repeated as they could or 10 times), ankle plantarflexors and ankle dorsiflexors(10 repetitions, using a handrail or not),and Sandbags weighing about 0.5 kg were used. 15 min balance exercise comprised knee bends, backwards walking, ‘8’ shape walking, sideways walking, tandem stand, heel-toe walking, one-leg standing, heel walking, toe walking, backwards heel-toe walking, sit-to-stand exercises and stair walking[24]. Physiotherapists guided participants to increase or decrease the exercise level according to an exercise level table. More detail is available from the Otago Medical School website (www.acc.co.nz/otagoexerciseprogramme)[27]. 

Outcome measures

Data were collected at baseline and 6 weeks and 12 weeks after the beginning of the intervention.Data regarding age,gender,marriage status,education, religion,Body Mass Index(BMI) and comorbidity was taken from gathered during interviews with the participants by trained research assistants who were blinded to group assignment.

Physical frailty was assessed by Fried phenotype including five domains: unintentional weight loss; exhaustion,drawn from the Center for Epidemiological Studies Depression scale(CESD)[28], with answers of more than 3 days considered as exhaustion; low physical activity according to the Minnesota Questionnaire Assessment Scale[29]; weak muscle strength as evaluated by hand strength, which was measured by using electronic hand dynamometer (Zhongshan Camry Electronic Co. Ltd, Guangdong, China) and slowness was evaluated by gait speed, which was identified by measuring the time needed to walk 4.6 m as quickly as possible. Weak muscle strength and slowness cut-off points were based on sex and BMI respectively[30]. Participants were classified as frail (presence of three or more criteria), pre-frail (presence one or two criteria) or robust (no criteria).

Cognitive function was measured using the Beijing version of the Montreal Cognitive Assessment (MOCA-BJ) scale. The test covers seven domains: visualisation/executive functions (maximum is equal to 5), naming (maximum is equal to 3), attention (maximum is equal to 3), language facilities (maximum is equal to 3), delayed memory (maximum is equal to 5), abstraction (maximum is equal to 2) and orientation (maximum is equal to 6)[26]. The total MOCA-BJ score ranges from 0 to 30 points, and scores between 19 and 25 indicate MCI.

Barthel Index was used which were translated and adapted in Chinese to evaluate ADL.Barthel Index comprises 10 items,they are feeding, bathing,make up, dressing, controlling bowel,controlling bladder,personal toileting, moving from wheelchair to bed and returning,walking on level surface, and ascending and descending stairs.The total score ranges

between 0 and 100 (the lower the score, the greater the dependence)[31].  

Ethics

The study protocol was approved by the Ethics Committee of Xiangya Nursing School of Central South University,China (No. E202042). The elderly gave their informed consent to participate in the research project. 

Randomization

A random number table was used to randomly divided these participants into two equal-sized 

Groups (31 participants in each group). The participants and physiotherapist were unable to be blinded, but the outcome evaluation and data analysis assessor were blinded to the randomization. 

Statistical methods

SPSS version 18.0 was used to perform all data analyses.Descriptive statistics were used to describe and compare participants' baseline demographic data between groups. Continuous and categorical variables were described by Mean ± standard deviation and percentage. The differences between two groups were used to assess by Two-sample t tests, Kruskal–Wallis tests, and chi-square tests. The outcomes were measures by Repeated measurement (group × time). Analyses were assessd at a 0.05 level of significance.

Results

Demographic and clinical characteristics

One hundered and sixty-five elderly who living in nursing homes was assessed by training nurse. One hundered and three were included at the beginning, of 83 individual did not meet the inclusion criteria, and 15 dividual declined to participate. Face to face interview were used to screen and all participants were given informed consent. Finally, sisty-two elderly were paticipate in the study, they all coded by number. Figure 1 shows the flow diagram of the study progress.

At baseline, sixty-two participants were divied into OEP group and control group randomed. Six weeks later, two participants was withdrew from this study because of hospitalization, and one was refused continue the project at 12 weeks. Finally, the control group included 30 participants and the OEP group included 29 participants.

There were no statistically significant differences at baseline in sociodemographic and clinical characteristics between the two groups (see Table 1). Table 2 summarizes the main outcome in the two groups. There were no significant differences between the two groups in baseline scores for the physical frailty, MOCA and ADL.  

Outcome

Physical frailty measures for the two groups

The changes of frailty score between baseline and follow-up assessments for the intervention and control groups are shown in Table 3. After 6 weeks intervention (T1), the mean score (SD) of the OEP group (2.03 (0.81)) was higher than the score of the control group (1.41 (0.98)). And after 12 weeks follow-up (T2), the mean score (SD) of the OEP group (2.00 (0.96)) was much higher than control group was (1.17 (1.00)). The significant time effect (p < 0.05), group effect (p < 0.05) and the interaction effect between the intervention groups and time (p < 0.05) indicated that the group effects on the frailty score change from baseline differed significantly over time. Figure 2 depicts the changes from baseline for the physical frailty during the study period, the scores of control group was basically as the same as baseline, while the scores of OEP group decreased significantly over time.  

MOCA measures for the two groups

After intervention, the mean score (SD) of MOCA scores in the OEP group VS control group at T1 was ( 22.17 (2.99)) vs (20.30 (2.96)); At T2, the mean score (SD) of MOCA scores in the OEP group was higher than in control group (23.45 (3.66) ) vs (19.90 (3.25)). The results in table 3 revealed no significant time effect (p > 0.05) in two groups. But group effect (p < 0.05) and the interaction effect (p < 0.05) was significant which indicated that the group effects on the MOCA score change from baseline differed significantly over time. As shown in Figure 3, the scores of MOCA in OEP group was increased over time, while decreased in control group during the study period. 

ADL measures for the two groups

The mean MOCA score (SD) of the OEP group was 90.52 (9.39) in T1 and the same as T2. While in the control group, the MOCA scores at T1 was 89.00 (10.78), and at T2 was 88.50 (10.84).There was no significant group and interaction effect (P>0.05) of ADL scores between the intervention groups. Figure 4 depicts that mean changes of ADL score in OEP group was basically the same as baseline, While was decreased in the control group for the ADL scores over the 12-weeks.

Discussion

Aging compromises the body to external stimuli or the adaptive stress responses of an organ, for example,the ability to adapt in response to abrupt changes in health conditions[16].People with advanced age and cognitive frailty are more vulnerable.Previous studies suggested that it is important to have effective strategies for the delivery of care that range across the continuum of frailty,because of the heterogeneity of frailty in clinical presentation and the dynamically transition between states[18].But in the literature on this subject, there are only a few reports on OEP for cognitive frailty old persons. So our study aimed to determine the effects of 12 weeks of OEP training on physical frailty,cognitive statement and ADL outcomes among elderly people with cognitive frailty living in nursing homes.

The results of the study demonstrated that cognitive frailty old persons who participated in OEP sessions per week for a12-week period had increased parameters that helped assess physical frailty and cognitive condition.The larger positive changes were established in the OEP group.Our results support a recent study that reported exercise-based training was an effective therapy for physical performance and reducing physical frailty levels among elderly people[32].A systematic review provided evidence that frail older adults seemed to benefit from exercise interventions on most of the outcome measurements including mobility,balance and muscle strength[20].Guidelines from International Conference of Frailty and Sarcopenia Research(ICFSR)[33] suggested the suitable frequency of exercise was 2–3 times per week for 30–45 min one time, which was consistent with OEP in our study.Based on previous studies and recommendations regarding group physical activity sessions were more effective in improving frailty than individual sessions according to a systematic review[34].And our research for group OEP intervention is consistent with this conclusion.However, another study[35] suggested a duration of exercise more than 5 months may contribute to better outcomes. Therefore, further research could be needed to explore the optimal dose of OEP for cognitive frailty elderly.

Functional mobility and balance are affected by physiological ageing and degeneration of proprioception, and the vestibular system occurs as one grows older,and ageing is associated with lowered cognitive and physical function[36].Cognitive frailty is defined as medical syndromes identified physical frailty and mild cognitive impairment,and physical frailty includes unintentional weight loss,self-reported exhaustion,low physical activity,weakness and slowness.In one hand,Our study showed that the OEP can improve the physical frailty,which is related to improve physical activity and weakness as defined.And in our anther report,we found that OEP improved mobility and balance in the cognitive frailty elderly[27],which also explained the reason for improving physical frailty.In another hand,We found significant improvements in cognitive impairment following the OEP training compared with the control group after 12 weeks.That is because OEP is helpful in training the brain and coordination of muscles and nerves, improving the body's proprioceptive ability and training the visual vestibular function[37].

The results of our study may be useful when developing further strategies that aim to improve the cognitive frailty condition.But the results of this study indicate that there was no significant effect of OEP on ADL for cognitive frailty. It was the same in the paper which reported inefficacy of physical activity on ADL functional[38]. But a recent randomized controlled trial showed that a protocol of semi-immersive video-game based therapy may be effective for improving quality of life in patients with subacute stroke in 8 weeks[39].So future research could be necessary to answer the question about how long time and which exercises should benefit cognitive frailty elderly on improving ADL.

Conclusions

In conclusion, our findings indicate that the 12-week OEP had better outcomes with respect to physical frailty and cognitive function for cognitive frailty elderly,but no effective on ADL.Further studies may also be able to find the OEP scheme on improving ADL.

Abbreviations

MCI:mild cognitive impairment;ADL: Activities of daily living;OEP:Otago exercise programme;RCT:randomised controlled trial;MOCA-BJ:the Beijing version of the Montreal Cognitive Assessment;ANOVA:analysis of variance;ICFSR:International Conference of Frailty and Sarcopenia Research 

Declarations

Ethics approval and consent to participate

In line with the provisions set forth in the Declaration of Helsinki the seniors were informed about the purpose of the study. Mmeanwhile, we get informed consent from all subjects. Ethical approval was obtained from the Ethics Committee of the Xiangya Nursing school, Central South University (No. E202042). All methods were carried out in accordance with relevant guidelines and regulations. 

Funding 

The study is supported by National Natural Science Foundation of China (Grant No.81770833, 81974223, 82071593), Health and Family Planning Commission of Hunan Province, China (Grant No.202214012762), Natural Science Foundation of Hunan Province (Grant No.2021JJ70068), the Educational Reform Project of the Central South University(2020jy165), and the Nursing Research Project of the Second Xiangya Hospital, Central South University (2019-HLKY-32，2021-HLKY-03).   

Authors’ contributions

Conception and design, drafting the manuscript, Xi Chen;supervision,Liping ZHAO, Jianliang CHEN, Jinnan OU,Youshuo LIU; formal analysis,Zhiming ZHOU, Dongli WEI, Fu MIN, and Xiaomei YANG ;Conception and design,Hua ZHANG, Yan LI; investigation,Jin HUANG; Conceptualization,Caili MA. Drafting manuscript, Haiwan ZHANG.All authors have read and agreed to the published version of the manuscript. The author(s) read and approved the final manuscript. 

Acknowledgments

The authors would like to thank Changsha NO.1 Social Welfare Institution and Geriatric Rehabilitation Hospital of Changsha, and all those participants for their collaboration. 

Consent for publication

Not applicable. 

Competing interests

The authors declare that they have no competing interests. 

Availability of data and materials

In this study all data used were stored at http://www.chictr.org.cn/index.aspx 

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Tables

Table 1 

Baseline characteristics by study groups

 BMI:Body mass index; a: Independent t-test, b:Fisher’s Exact Test;* p＜0.05.

Table 2

Baseline outcome variables of participants in the control and OEP groups

MoCA: Montreal Cognitive Assessment; ADL: Activities of Daily Living. 

Table 3

Comparison of mean scores of outcome variables between two groups

MoCA: Montreal Cognitive Assessment; ADL: Activities of Daily Living; MD, mean difference; SD, Stadard deviation;*p＜0.05.