Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

doi:10.21203/rs.3.rs-2097470/v1

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Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-2097470/v1

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published 15 Aug, 2023

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Background: Evidence has shown that patients with chronic obstructive pulmonary disease present significant deficits in the control of postural balance when compared to healthy subjects. In view of this, it is pertinent to investigate the effects of different therapeutic strategies used alone or in association with pulmonary rehabilitation with the potential to improve postural balance and other outcomes with clinical significance in patients with chronic obstructive pulmonary disease.

Objective: This study will investigate the effects of a 8-week (short-term) multimodal exercise program [inspiratory muscle training (IMT) plus neuromuscular electrical stimulation (NMES)] on postural balance in patients with chronic obstructive pulmonary disease enrolled in a pulmonary rehabilitation program compared to individualized addition of IMT or NMES to pulmonary rehabilitation or standard pulmonary rehabilitation.

Methods: Randomized, single-blind, 4-parallel-group trial. 40 patients with chronic obstructive pulmonary disease will be included prospectively to this study during a pulmonary rehabilitation program. Patients will be randomly assigned to one of four groups: multimodal exercise program (IMT + NMES + pulmonary rehabilitation group) or (IMT + pulmonary rehabilitation group) or (NMES + pulmonary rehabilitation group) or standard pulmonary rehabilitation group. Patients will receive two sessions per week for 8 weeks. The primary outcome will be static postural balance and secondary outcomes will include: static and dynamic postural balance, fear of falling, muscle strength and endurance (peripheral and respiratory), functional capacity, health-related quality of life, muscle architecture (quadriceps femoris and diaphragm) and laboratory biomarkers.

Discussion: This randomized clinical trial will investigate the effects of adding of short-term multimodal exercise program, in addition to pulmonary rehabilitation program, in postural balance in patients with chronic obstructive pulmonary disease enrolled in a pulmonary rehabilitation. Furthermore, this randomized control trial will enable important directions regarding the effectiveness of short-term intervention as part of the need to expand the focus of pulmonary rehabilitation to included balance management in chronic obstructive pulmonary disease patients will be generated.

Trial registration: ClinicalTrials.gov NCT04387318. Registered on May 13, 2020.

Breathing exercises

Electric stimulation

Postural balance

Rehabilitation

Oxidative stress is involved in the pathogenesis and progression of chronic obstructive pulmonary disease (COPD) causing cell damage [1]. In this scenario, clinical studies demonstrate in DNA a significant increase damage and inefficiency in repair mechanisms, may lead to genomic instability and cellular senescence in patients with COPD [2]. The primary pathophysiology of COPD is related to damage to the respiratory system [3]. However, the respiratory and limb muscle dysfunction appears to be a major systemic manifestation in COPD [4], contributing to reduction in functional capacity and health-related quality of life (HRQoL) [5].

Recent meta-analysis showed that compared with healthy controls, people with COPD have clinically meaningful balance reduction [6]. Balance impairment is one of the main risk factors for the occurrence of falls, and people with COPD are four times more likely to fall than healthy peers, leading to increased morbidity and mortality [6,7].

Because it is a complex and systemic disease, the treatment of COPD requires an integrated therapeutic approach, including the referral for pulmonary rehabilitation (PR) [3]. The PR has been demonstrated to reduce dyspnea, improve exercise capacity and HRQoL, whose core components include aerobic and strength training [8,9]. However, even accumulated evidence on balance impairment in patients with COPD, the routine assessment of this outcome is still not part of PR [8,9]. The American Thoracic Society (ATS)/European Respiratory Society (ERS) Statement on Pulmonary Rehabilitation briefly presents the broadened of the scope of outcomes assessment in PR including balance. Nevertheless, the focus of PR should be expanded to include the assessment, training and elucidate the potential mechanisms underlying balance deficits in COPD [6].

In addition, respiratory and limb muscle dysfunction have particular relevance in the COPD, because they are contributing factors to balance impairment [4,6,10]. In this sense, it is worth noting that the diaphragm plays an important role in postural balance and the impairment function of this muscle observed in COPD contributes to the deterioration in balance [11]. Therefore, it is reasonable to infer that multimodal exercise program [inspiratory muscle training (IMT) plus neuromuscular electrical stimulation (NMES)] could be considered as a potential procedure to improve postural balance. These therapeutic strategies have been used in an incipient way as complements to PR [12,13]. However, no studies have assessed the efficacy of short-term multimodal exercise program in addition to PR in COPD patients.

Therefore, the aim of this study will be to investigate the effects of short-term multimodal exercise program (IMT plus NMES) compared to individualized addition of IMT or NMES to PR or standard PR on postural balance, fear of falling, muscle strength and endurance (peripheral and respiratory), functional capacity, HRQoL, muscle architecture (quadriceps and diaphragm), inflammatory profile, endothelial function, oxidative stress, and DNA damage in patients with COPD. We hypothesize that the addition of multimodal exercise program can potentiate the aforementioned outcomes.

Study design

This is a protocol for a clinical, randomized, controlled, single-blind (outcomes assessor), four-arm parallel-group, conducted at the “X”. The study was approved by the ethics committee (process no. 3.208.982). The protocol was designed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and will be conducted according to the Consolidated Standards of Reporting Trials (CONSORT) statement. All laboratory specimens and data collection forms will be identified by a coded ID number to maintain participant confidentiality. All subjects will provide written informed consent, and the trial was registered at ClinicalTrials.gov (“X”). Any changes to the study protocol will be submitted to the local Research Ethics Committee.

The results of this study will be communicated to health authorities, health professionals, and the general public, at events and through publications in scientific journals as soon as the results are available. Furthermore, the patients will individually receive a report, end of the study, with the performance obtained in the evaluations in the pre- and post-intervention moments.

Study participants and eligibility criteria

The eligibility criteria include patients with 55 years or more (adult, older adult) of both sexes.

Inclusion Criteria:

Clinical diagnosis of COPD, stages II, III or IV [3];
Clinically stable, i.e., absence of infections or exacerbations in the last 3 months;
Medical clearance to participate in PR;
Availability of attending to the PR.

Exclusion criteria:

Unstable primary pathologies (cardiovascular, renal, metabolic or psychiatric);
Nutritional aspects (nutritional supplementation on the 4 weeks preceding the study or obesity (BMI > 30 Kg/m²));
Severe hearing, visual or vestibular disorders impairment recorded on patient chart or self-referred;
Evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control;
Contraindications to NMES;
Participation in PR programs in the 3 months previous to the study or physically active;
Active smoker and/or active alcohol;
Cognitive impairment.

Sample size

Based on the data from a previous study [13] it will be necessary in a minimum sample size of 10 individuals per group and a total of 40 patients, considering the variable of mean lateral displacement of the pressure center mid-lateral displacement amplitude (COPml) in the follow-up of the intervention group, which performed NMES associated with PR program (± 12.1 mm) and the control group that only performed standard PR (± 7.2 mm). We also considered p value < 0.05, power of 80% and loss of 20%.

Randomization and allocation

A computer-generated list of random numbers will be used, and a randomization sequence will be created by the Random Number Generator Pro v2.00 software (Segobit, Issaquah, WA, USA). Patients will be randomized (1:1:1:1) by single investigator blinded to patient identity (I.M.A.) to one of four groups: multimodal exercise program (IMT + NMES + PR group) or (IMT + PR group) or (NMES + PR group) or standard PR group. Assessments will be conducted by independent assessors who will be blinded to the group allocation. In addition, all data analyzes will also be blinded.

Procedures

All eligible patients will undergo the same assessments at the beginning and after 8 weeks of the study (Fig. 1).

Participant timeline

The participant timeline is shown in Fig. 2.

Primary outcome

Static postural balance

The primary outcome will be measured using the AMTI portable force platform model OR6-6-2000 (Advanced Mechanical Technologies, Inc.) with acquisition frequency of 100 Hz [14]. Standardized verbal instructions will be used to guide proper patient positioning. Three attempts lasting 30 seconds each, with 1 minute rest in between, will be performed (eyes open and then closed) and the average will be considered for analysis [15].

Body sway will be evaluated from the center of pressure (COP) and the variables will comprise COP anteroposterior displacement amplitude (COPap), COP mid-lateral displacement amplitude (COPml), COP displacement velocity (COPvel) and 95% ellipse area (AE). Then, the raw data obtained will be filtered using a fourth-order zero-lag Butterworth with 10 Hz cut-off frequency, and processed using custom Matlab routines (R2020a, The Mathworks, Inc., Massachusetts, USA).

Secondary outcomes

Secondary outcomes to be measured are static and dynamic postural balance, fear of falling, muscle strength and endurance (peripheral and respiratory), functional capacity, HRQoL, muscle architecture (quadriceps and diaphragm) and laboratory biomarkers.

Static postural balance

To assess vestibular, proprioceptive, and visual functions, dynamic flow-laser posturography will be used. Each evaluation will be performed three times for 20 seconds and considering for analysis the mean of the values obtained [16].

Dynamic postural balance

Dynamic postural balance will be assessed using the Timed Up and Go (TUG). Three tests will be performed and the best result one will be considered [17].

Static and dynamic postural balance

The Berg Balance Scale and the Balance Evaluation Systems Test (BESTest) will be also used to assess the static and dynamic postural balance [18,19].

Assessment of Fear of falling

The fear of falling will be assessed using the Falls Efficacy Scale-International-Brazil (FES-I-Brazil) [20] and the Activities-specific Balance Confidence (ABC) scale [21].

Respiratory muscle strength

The evaluation of respiratory muscle strength will be performed by means of measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with an MVD 300 digital manometer (MDI^®, RS, BR). The highest pressure of MIP and MEP will be considered [22].

Inspiratory Muscle Endurance

The assessment of inspiratory muscle endurance will be performed by using POWERbreathe® Medic Plus (POWERbreathe Medic Plus®, SP, BR), coupled to an analogical pressure transducer (WIKA, Alexander Wiegand SE & Co., Klingenberg, Germany). The evaluation will be composed of the incremental and constant tests [23].

Peripheral muscle strength

The assessment of upper limb muscle strength will be performed by hydraulic dynamometer (Saehan Corporation SH5001, Korea) and the highest value obtained in each limb considered for analysis [24]. Lower limb muscle strength will be evaluated using a MicroFET® (Hoggan Health Industries, West Jordan, UT, USA) handheld dynamometer. Five measurements will be taken for each limb, of which the highest and lowest values will be discarded and the average between the three remaining values calculated [25].

Peripheral muscle endurance

The peripheral muscle endurance will be evaluated through the 30-second sit-to-stand test (30-STST). The number of 30-s STS repetitions will be considered for analysis [26].

Functional capacity

Functional capacity will be evaluated by the six-minute walk test (6MWT) and the longest walk distance will be considered for analysis [27].

Health-related quality of life (HRQoL)

The HRQoL will be assessed using the Saint George's Respiratory Questionnaire [28].

Diaphragm and peripheral skeletal muscle architecture

Diaphragm and peripheral skeletal muscle architecture (cross-sectional area, muscle layer thickness and echogenicity) will be assessed with high-resolution US (Mindray Ultrasound, portable DP-2200, China), in B mode, with an echocardiologic transducer (65C15EA 5.0–9.0 MHz, 4W). The image analysis will be performed in ImageJ® software (NIH, Bethesda, MD, USA) [29,30].

Laboratorial biomarkers

Blood samples will be collected after a period 8-h overnight fast. Serum will be used for analysis of high-sensitivity C-reactive protein (hsCRP), total antioxidant capacity, total oxidant status, nitrate and nitrite, creatine phosphokinase and lactate dehydrogenase. The plasma will be used to assess the advanced oxidation protein products, ferric reducing ability of plasma, Thiobarbituric Acid-Reactive Substances assay, protein carbonylation, DNA damage and muscular. The biological samples will be stored in the Research Laboratories in Clinical Biochemistry and Biogenomics at “X”.

Inflammatory biomarker

The hsCRP will be used as an inflammatory biomarker and calculated using standard method on a Mindray automated system (BS 380®, Shenzhen, China).

Endothelial function

The nitrate and nitrite levels will be used to assess endothelial function, on the Mindray automated system (BS 380®, Shenzhen, China), according to the modified Griess method by Tatsch et al. (2011) [31].

Oxidative stress

The oxidant profile will be analyzed by the Thiobarbituric Acid-Reactive Substances assay, advanced oxidation protein products, protein carbonylation test and the total oxidant status. The antioxidant profile will be measured by means of the total antioxidant capacity and the ferric reducing ability of plasma. The sample treatment will be based on established methods.

Muscular damage

Muscle damage will be evaluated by the Total creatine phosphokinase, lactate dehydrogenase and lactate that will be calculated using standard method on a Mindray automated system (BS 380®, Shenzhen, China).

DNA damage

The DNA damage will be measured by the comet assay and micronuclei analysis. We will select and analysis images of 100 cells from each sample according to tail length from 0 (no migration) to 4 (maximal migration), resulting in single DNA damage score (DNA damage index) [32]. Two different evaluators will analyze the slides under blind conditions [33]. Micronuclei analysis will be performed in peripheral blood lymphocytes as previously described [34].

Interventions

After baseline evaluations, all subjects will receive the therapeutic modality proposed according to the group to which they will be randomly (Fig. 3). All interventions will occur under direct supervision of a physical therapist aiming to improve adherence to intervention protocols (blinded to outcome assessment), for 8 weeks, two times per week, totaling 16 sessions. Vital signs will be continuously monitored, and possible adverse events will be recorded. The patients will be instructed not to perform any other form of exercise during the intervention.

Inspiratory muscle training

The patients randomized to the groups (IMT + NMES + PR) and (IMT + PR) will performed IMT using the POWERbreathe® Medic Plus (POWERbreathe Medic Plus®, SP, BR). The training initial load in will be at 30% of the MIP (obtained by manovacuometry) during the first two weeks to allow for an adjustment period. Load increases will occur as follows: 35% of MIP in week 3, 40% of MIP in week 4, 45% of MIP in week 5, 50% of MIP at week 6, 55% of MIP in week 7, and 60% of MIP in weeks 8. The IMT will consist of five sets of 10 repetitions each, with a one-minute interval between each set, twice a week for eight weeks. During training, patients will instructed to maintain diaphragmatic breathing. In order to get feedback regarding perceived inspiratory effort, the modified Borg CR10 scale (4–6 out of 10) will be considered.

Neuromuscular electrical stimulation (NMES)

The groups (IMT + NMES + PR) and (NMES + PR) will receive the NMES for 16 sessions (2 days per week for 8 weeks). NMES will be applied bilaterally using an electrical stimulator (Neurodyn II, model N53, IBRAMED, SP, BR) with one proximal electrode (7.5 x 13 cm) in the motor point of the quadriceps muscle and another distal electrode above the upper pole of the patella [35]. The patient will be in dorsal decubitus, lower limbs on a foam wedge and knees flexed at 60° [35]. The NMES protocol will consist of the application of symmetrical biphasic rectangular pulses, 50 Hz frequency, 400 ms pulse width, stimulation (ON) time will be 5 s and relaxation (OFF) time is 15 s (first month) and 10 s ON and 30 s OFF (second month). The maximum intensity tolerated progressively will be used, resulting in should culminate in visible and comfortable muscle contraction [14,35].

Pulmonary rehabilitation programme

All patients will be performed PR programme for approximately 60 minutes per session. Firstly, aerobic training will be performed on a cycle ergometry (Kikos kr5.6 bivolt, SP, BR) for 30 minutes; whose training intensity target will initially be of 60% of the maximum work rate [36]. The increment of exercise intensity will also be based on the rating of perceived exertion (4–6 on the modified Borg scale) [8,9]. Furthermore, the heart rate target will be kept between 50 to 80% of resting HR [8]. Afterwards, strength training will be performed through exercises for the upper and lower limbs, three sets of 8 repetitions will be performed at intensities initially defined in 50% of the one repetition maximum (1RM) with weekly increase until reaching 80% of the 1RM at the end of 8 weeks [8,9].

Data analysis

The data will be analyzed using GraphPad Prism 5 (GraphPad Software Inc., San Diego, CA, USA). The normality of variables will be assessed by the Shapiro-Wilk test. The continuous variables with normal distribution and those with non-normal distribution will be presented as mean ± standard deviation (SD), 95% confidence interval (95% CI) and median (interquartile range), respectively, while categorical variables will be presented as absolute frequencies and percentages. Student's t test for paired samples (parametric data) or Wilcoxon test (non-parametric data) will be used to compare the results before and after the intragroup intervention according to data distribution, and the effect size will be calculated using Cohen's d. Comparison between groups will be performed using two-way analysis of variance (ANOVA) with repeated measures, followed by Bonferroni's post-hoc. In addition, we will use analysis of covariance (ANCOVA), as a supportive analysis, to compare differences between groups after the intervention, adjusting for values of the respective outcomes at baseline. Effect size was calculated using Cohen's d. Intention-to-treat analysis will be applied to include all randomised participants. The significance level will be set at 5% (p < 0.05).

It is noteworthy that, as far as we know, this is the first study to investigate the effects of short-term multimodal exercise program on postural balance and other outcomes with clinical significance in patients with COPD. Previous studies demonstrates that deficits in postural balance are increasingly recognized among the important secondary impairments in COPD patients [6,7,10]. In addition, many risk factors that lead to an impaired postural balance are common to aging process and systemic manifestations of COPD. Thus, it is reasonable to infer that most individuals with COPD are doubly affected [37]. However, the description of pulmonary rehabilitation components in the ATS/ERS Pulmonary Rehabilitation Statement do not address the use of resources or strategies focused on improving postural balance [8,9].

In this context, it is necessary to expand the focus of PR to include assessment and therapeutic strategies to improve balance. Considering that COPD is a complex inflammatory disease that involves several types of inflammatory cells and multiple inflammatory mediators [38], novel models of PR should address a comprehensive understanding that incorporate the physiological and functional implications of different intervention strategies in a clinical setting. Nevertheless, the current evidence on the effects of multimodal exercise program on postural balance in patients with COPD is a significant gap in the literature.

Based on recent recommendations from the official ATS workshop report international guidelines, a new approach to the future of pulmonary rehabilitation is needed [39]. Consistent with these recommendations and ensure the principle of personalized rehabilitation, a combination of interventions that included the use of IMT and NMES may be particularly relevant. Considering the IMT, Janssens et al. (2013) was pioneer to encourage further studies to determine the effects of IMT on the postural balance in patients with COPD [40]. Recently, a randomized controlled trial demonstrated that IMT combined with endurance training enhances inspiratory muscle function and balance in these patients [12]. Additionally, NMES was able to reduce DNA damage in patients with chronic kidney failure [35] and added to PR improve static postural balance in COPD patients [13]. In this sense, the results from this study will reveal relevant clinical information about the adoption of new PR models through multimodal exercise program. The results also could be able to transfer of knowledge into clinical practice in the field of physical therapy.

Our study has both strengths and limitations. Strengths include the adoption of multimodal exercise program because this strategy may to promotes additional benefits on clinically relevant outcomes; we will also use the protocol over a short-term intervention and we will include laboratory biomarkers of inflammatory profile, endothelial function, oxidative stress and DNA damage that had not been reported in previous studies comparing therapeutic strategies in COPD patients; we will implement a combination of strategies modalities considered of low-cost and feasible. The limitation refers to the impossibility of carrying out a multicenter study and due to the type of intervention it will not be possible to blind the therapist to the treatment allocation.

The results from will reveal relevant clinical information about the adoption of new PR models through multimodal exercise program. Thus allowing to expand the focus of PR to include the assessment and balance deficits training in COPD. Physical therapists will be able to transfer this knowledge in clinical practice to improve the treatment of these patients.

Trial Status Status Do Teste

ClinicalTrials.gov – NCT04387318. The protocol version is number 2.0, dated May 17, 2022. https://clinicaltrials.gov/ct2/show/NCT04387318?term=NCT04387318&draw=2&rank=1 The first patient was recruited on August 01, 2021; the recruitment will be completed on December 20, 2022.

ABC: Activities-specific Balance Confidence Scale

AE: 95% ellipse area

ANCOVA: Covariance

ANOVA: Two-way analysis of variance

ATS: American Thoracic Society

BESTest: Balance Evaluation Systems Test

CONSORT: Consolidated Standards of Reporting Trials

COP: Center of pressure

COPap: COP anteroposterior displacement amplitude

COPD: Chronic obstructive pulmonary disease

COPml: COP mid-lateral displacement amplitude

COPvel: COP displacement velocity

ERS: European Respiratory Society

FES-I-Brazil: Falls Efficacy Scale-International-Brazil

HRQoL: Health-related quality of life

hsCRP: High-sensitivity C-reactive protein

IMT: Inspiratory muscle training

MEP: Maximal expiratory pressure

MIP: Maximal inspiratory pressure

NMES: Neuromuscular electrical stimulation

95% CI: 95% confidence interval

PR: Pulmonary rehabilitation

6MWT: Six-minute walk test

SD: Standard deviation

SPIRIT: Recommendations for Interventional Trials

30-STST: 30-second sit-to-stand test

TUG: Timed Up and Go

1RM: One repetition maximum

Ethics approval and consent to participate

This study was approved by the Research Ethics Committee of the Federal University of Santa Maria (process no. 3.208.982) and will be carried out in accordance with ethical criteria in research with human beings of the Resolution of the National Commission for Ethics in Research (nº 466/12), National Health Council/Ministry of Health, and other Brazilian Ethical Resolutions. All subjects will provide written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors report no conflicts of interest.

Funding

Not applicable.

Authors' contributions

TDS, DMC, ARS, and IMA wrote the paper. TDS, ASP, IBMC, RNM and IMA organized the clinical support for execution of the trial. TDS and DMC developed the statistical analysis plan. IMA is the supervisor and lead contact. TDS and IMA conceived the study and led the proposal and protocol development. All authors contributed to the study design and to the development of the proposal. All authors read and approved the final manuscript.

Availability of data and materials

The datasets generated during and/or analyzed during the current study will be made available with other researchers on duly justified request. The authors TDS, DMC, AFS and IMA will have access to the final test data set.

Acknowledgements

The authors would like to express thanks for the financial grant support provided by CAPES.

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published 15 Aug, 2023

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Editorial decision: Major revision
01 Apr, 2023
Reviewers agreed at journal
11 Nov, 2022
Reviewers invited by journal
10 Nov, 2022
Editor assigned by journal
11 Oct, 2022
First submitted to journal
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Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Status:

Journal Publication

Version 1

Abstract

Figures

Introduction

Methods

Study design

Study participants and eligibility criteria

Sample size

Randomization and allocation

Procedures

Participant timeline

Primary outcome

Static postural balance

Secondary outcomes

Static postural balance

Dynamic postural balance

Static and dynamic postural balance

Assessment of Fear of falling

Respiratory muscle strength

Inspiratory Muscle Endurance

Peripheral muscle strength

Peripheral muscle endurance

Functional capacity

Health-related quality of life (HRQoL)

Diaphragm and peripheral skeletal muscle architecture

Laboratorial biomarkers

Inflammatory biomarker

Endothelial function

Oxidative stress

Muscular damage

DNA damage

Interventions

Inspiratory muscle training

Neuromuscular electrical stimulation (NMES)

Pulmonary rehabilitation programme

Data analysis

Discussion

Trial Status Status Do Teste

Abbreviations

Declarations

Ethics approval and consent to participate

Consent for publication

Competing interests

Funding

Authors' contributions

Availability of data and materials

Acknowledgements

References

Supplementary Files

Status:

Journal Publication

Version 1