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Pulmonary rehabilitation with balance training for fall reduction in chronic obstructive pulmonary disease: a randomized controlled trial

BMC Pulmonary Medicine volume 24, Article number: 408 (2024) Cite this article

Abstract

Background and objectives

Available evidence suggests that adults with chronic obstructive pulmonary disease (COPD) performed substantially worse than healthy controls on many balance measures and balance training can improve the balance measures in this population. We conducted this study to determine the effects of incorporating balance training into pulmonary rehabilitation (PR) on the incidence of falls at 12 months follow-up in high fall risk adults with COPD.

Methods

We conducted a prospective international multi-center randomized controlled trial. Eligible participants were adults with COPD at a high risk of future falls and were randomly assigned (1:1) to the intervention or control group. The intervention included personalized balance training for a targeted total of 90 min per week. Both the intervention and control groups received usual PR (2–3 times per week for 8–12 weeks). The primary outcome was the incidence of falls at 12-month follow-up using monthly fall diary calendars. Negative binomial regression or recurrent events models were used to examine the effects of the intervention on fall events. Multiple imputations were performed to deal with missing values.

Results

Of 258 participants who were enrolled in the trial, 178 provided falls information (intervention group = 91, control group = 87) and were included in the main analysis. Forty-one participants (45%) experienced at least one fall event in the intervention group and 33 (38%) in the control group (p = 0.34). The mean incidence of falls at 12 months was similar between the two groups (128 versus 128 per 100 person-years; mean difference: 0.30, 95% CI: -0.76 to 1.36 per 100 person-years). The results are robust after multiple imputations for missing data (n = 67).

Conclusions

PR incorporating balance training compared to PR alone did not reduce the incidence of falls over the 12-month period in high fall risk adults with COPD.

Trial registration

The study was registered with ClinicalTrials.gov (NCT02995681) on 14/12/2016.

Peer Review reports

Background

Chronic obstructive pulmonary disease (COPD) is a major public health problem and primarily affects breathing by causing airflow limitation and respiratory symptoms [1]. However, it can also cause various non-respiratory impairments such as pain, sleep disorders, depression, and cognitive decline [2]. An increased risk of falls is also one of the recognized non-respiratory impairments that is closely related to several adverse outcomes, including future falls, injury, emergency department visits, hospitalization, mobility disability and death [3,4,5]. Falls are also associated with increased health-related costs [4, 5].

In adults with stable COPD, the prevalence of individuals who fall is 30%, and the fall incidence rate varies from 117 to 149 events per 100 person-years [6]. Adults with COPD are 55% more likely to have accidental fall than non-COPD individuals [7]. Adults with COPD share similar fall risk factors to general older adults, including increased age, women, fall history in the past year, increased fear of falling, comorbidities, and polypharmacy [6]. In addition to these factors, the use of supplemental oxygen, heavy smoking history and impaired balance have been identified as specific fall risk factors related to individuals with COPD [6, 8]. Adults with COPD performed substantially worse than healthy controls on many balance measures, such as Timed Up and Go, single leg stance and Berg Balance Scale (BBS) [9].

Pulmonary rehabilitation (PR) is a core component of COPD management. It includes comprehensive multidisciplinary interventions such as exercise training, education, self-management strategies and psychosocial support to improve physical and emotional status [10]. Despite evidence suggest that adults with COPD performed substantially worse than healthy controls on many balance measures, guidelines for PR do not explicitly emphasize the importance of balance training in this population [10]. Previous studies have shown that adding balance training to PR significantly improves several functional balance measures [11,12,13,14,15,16,17]. For example, our research group conducted a pilot randomized controlled trial (RCT), which demonstrated that adding balance training (three times a week for six weeks) to PR significantly improved balance and physical function measures compared to PR alone [17]. However, whether the effectiveness of adding balance training to PR on these surrogate outcomes (e.g., balance measures) to falls can be transferred to effects on fall events is still unclear.

This RCT was conducted to determine the effect of 8–12 weeks of PR plus balance training compared to PR on falls, balance, and functional measures in individuals with COPD. We hypothesized that adding balance training to PR would reduce future falls and improve balance measures.

Methods

This prospective, parallel-group, international multi-center RCT was conducted in Canada, the United Kingdom, Portugal, and Australia. The RCT was registered with ClinicalTrials.gov (NCT02995681) on 14/12/2016, the study protocol was published before enrolling the first participant [18]. We are reporting the main findings of this RCT according to the CONSORT statement [19]. Nine research sites with outpatient PR programs obtained ethics approval and all participants provided written informed consent to participate in this study [18]. The committees’ names and approval numbers are provided in Appendix 1 and the declaration section.

Adults with COPD and high fall risk were recruited upon enrollment in PR programs at each site between 2017 and 2021. COPD was diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, in which post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) < 0.7 is mandatory [20]. This trial defined high fall risk as participants with self-reported balance impairment, a fall history within the last two years or a recent near fall [18]. The trial excluded participants if they could not communicate due to a lack of sufficient language skills (English or Portuguese required depending on the research site), were hearing or cognitively impaired or had comorbid conditions that severely limited mobility and postural control (i.e., that impeded the participant’s ability to safely complete the required balance training).

Eligible participants were randomly assigned (1:1) to the intervention or control groups. The central research coordinator generated a block randomization table using an online random number generator (www.randomizer.org) and created opaque envelopes for each research site. Once the baseline assessment was completed, the central research coordinator opened consecutive envelopes and informed the local site lead or a member of the study staff of the participant’s group allocation. The outcome assessors and data analysts were blinded to the group allocation.

Both the intervention and control groups participated in usual PR (2–3 times per week for 8–12 weeks, depending on the research site). All research sites offered PR following international guidelines: aerobic and resistance exercise, psychosocial support, and education [21, 22]. The duration of each PR session usually lasts one to two hours. After discharge from outpatient PR, all participants were instructed to continue individualized exercises such as walking and upper and lower extremity resistance exercises 2 to 3 times per week. All participants were asked to return monthly home exercise (completed duration for each exercise) and fall diary calendars using pre-paid envelopes; participants who had any fall events were asked to contact the research staff to provide additional information. Participants in both groups also received home visits by a physiotherapist at 3-, 6- and 9-months post-PR to help progress their home program.

Participants in the intervention group received 30 min of balance training three times per week (two sessions in clinic supervised by physical therapists and one at home for a total of 90 min) in addition to usual PR. Balance training exercises were prescribed based on the participants’ baseline balance assessment and the intervention details were presented in the protocol [18]. After completion of PR, participants were instructed to continue their home balance exercise program throughout the follow-up period and the frequency of home balance training was increased to three times per week to maintain a total of 90 min per week. Adequate adherence was defined as completing at least 70% of the planned balance training time. The home visits at 3-, 6- and 9-month post-intervention were used to progress balance training exercises in the intervention group.

The primary outcome was the incidence of falls at 12-month follow-up. A fall was defined as “an incident in which the body unintentionally comes to rest on the ground or other lower level which is not due to a violent blow, loss of consciousness, sudden onset of paralysis as in a stroke or an epileptic seizure” [23]. The injurious falls were identified as fall-related incidents requiring medical attention through follow-up phone interviews and self-reported responses. Additional fall details (i.e., circumstances of the fall(s), injurious vs non-injurious) were also documented. The research staff contacted participants by telephone if they did not return their fall diaries or if there was unclear data (e.g., unclear handwriting) on their monthly reports.

The secondary outcomes were balance measures. The pre-set minimal important difference (MID) values for each measure were used to interpret our findings. These balance measures include the Berg Balance Scale (BBS, range: 0–56, MID: 5 points), Balance Evaluation Systems Test (BESTest, range: 0–100%, MID: 13 points), and Activities-Specific Balance Confidence scale (ABC scale, range 0-100%, MID: 19) [24]. The 30-second Chair Stand Test (Sit to Stand test) was used to measure lower body strength. The outcome assessors administered these measures three times: pre-intervention (baseline), immediately post-intervention and 12-months post-intervention.

Statistical analysis

The target sample size was 400 based on the anticipated relative effect (30% risk reduction), baseline risk for falls (120 falls per 100-person years), type I error (5%), 80% power and loss to follow-up of 15–20%. However, the COVID-19 pandemic caused the suspension of participant recruitment when 246 participants (125 in the intervention group and 120 in the control group) were included. The steering committee subsequently stopped this trial due to site staffing limitations and the feasibility of recruiting more participants.

Incidence and number of falls, injurious falls, and the time to the first fall were reported according to the recommended methodology for reporting fall outcomes in clinical trials [25]. Negative binomial regression models with group allocation as the independent variable and age, sex and fall history as covariates were used to examine the effect of the intervention on the incidence and number of falls or injurious falls. Recurrent event models were used to examine the effect of the intervention on fall status by considering the status of events and the observed time. Marginal models with autoregressive covariance structures with baseline scores, age, gender, and fall history as covariates were used to examine the effect of the intervention on repeated measures, which included BBS, BESTest, ABC scale and 30-second repeated chair stand test.

Multiple imputations (Predictive Mean Matching method) by considering participants’ baseline variables, including age, gender, fall history, and baseline number of the 30-second chair stand test (due to statistically significant differences in these variables between the analyzed data and the complete missing dataset, Table E1), were conducted to deal with missing values on the number and incidence of falls, which yielded 10 complete datasets. The models were re-analyzed after imputation to evaluate the effect of the intervention on primary outcomes as a sensitivity analysis. All analyses were performed with Stata 17.0 or R 4.2. A two-sided p-value of less than 0.5 was considered statistically significant. Appendix 2 shows the code of the main analysis. Two sensitivity analyses were conducted based on fall history and adherence to balance training (at least 70% adherence). The analyses hypothesized that those with a fall history and those with high adherence to balance training would show a larger effect on fall outcomes. Appendix 3 presents the characteristics of participants, categorized by their missing status and provides distributions of the outcome measures.

Results

This study enrolled 258 participants. Figure 1 shows the flow chart of the study. After consented, 13 participants was excluded due to various reasons (Fig. 1) . This left 245 participants, with a mean age of 72 ± 9 years (ranging from 37 to 95 years), of whom 104 (42%) were female and 146 (60%) had a fall history. Of the 245 participants, 67 did not report any fall information during the 12-month follow-up period and were thus excluded from our primary analysis of falls. Therefore, 178 participants (intervention group = 91, control group = 87) were included in the main analysis with well-balanced baseline characteristics between the two groups (Table 1). Forty-four participants (48%) in the intervention group completed at least 70% of the planned balance training.

Fig. 1
figure 1

Flow chart of the study. Legends: ABC scale: Activities-specific balance confidence scale; AECOPD: Acute exacerbation ofhronic obstructive pulmonary disease;  BBS: berg balance scale; BESTest: balance evaluation systems test; PR: Pulmonary rehabilitation

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Table 1 Baseline characteristics of participants
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Fall outcomes

One fall incident was reported during a home balance training session. The incidence of falls was the same between the two groups (128 versus 128 per 100 person-years). There was no statistically significant effect of adding balance training to PR on the incidence of falls (mean difference [MD]: 0.30, 95% CI: -0.76 to 1.36 per 100 person-years) in the Negative Binomial regression models. The incidence of injurious falls was similar between the two groups and there was no significant effect of the intervention on injurious falls. Participants in the intervention group experienced a similar number of falls to those in the control group (1.10 versus 1.01,p = 0.57) (Table 2).

Table 2 The effect of the intervention on the number of fall outcomes
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The rate of recurrent fallers (24% versus 23%, p = 0.85, Table 3) and the time to first fall (5.1 versus 4.1 months, p = 0.30) was also similar between groups (Table 2). Forty-one participants (45%) experienced at least one fall event in the intervention group compared to 33 (38%) in the control group (p = 0.34, Table 3). Twenty-five participants (28%) experienced at least one injurious fall event in the intervention group and 18 (21%) in the control group (p = 0.34, Table 3). The results of recurrent survival models also showed no statistically significant effects of adding balance training to PR on the risk of falls, injurious falls, and recurrent falls (Table 3).

The analysis of fall outcomes after the imputations for missing data (65 imputed values for falls and 67 imputed values for injurious falls) yielded similar results as previous analyses (MD less than 1) (Appendix 4). The sensitivity analyses, which included only participants who completed at least 70% of the balance training (n = 44/91), as well as those with or without a fall history, did not reveal substantial differences in fall outcomes (Appendix 5).

Table 3 The effects of the intervention on fall status
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Balance and physical function measures

There was a significant between-group difference at the completion of PR in BBS scores (adjusted MD: 1.77, p = 0.038) and the number of repetitions in the 30-second repeated chair stand test (adjusted MD: 1.12 repetitions, p = 0.034) in favour of the intervention group, but no significant between-group differences in these outcomes at 12-month follow-up (Fig. 2, Appendix 3). There were no statistically significant between-group differences in BESTest scores and ABC scale scores post-PR/intervention or at 12-months (Fig. 2, Appendix 3).

Fig. 2
figure 2

The effects of the intervention on balance and physical function measures. Abbreviations MD: adjusted mean difference (adjusted for baseline score, age and sex)

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Discussion

In this international multi-center RCT, the incorporation of balance training into usual PR did not significantly reduce the occurrence of falls or injurious falls over a 12-month follow-up period compared to PR alone. Balance training added to PR improved balance as measured by the BBS and lower body strength as measured by the 30-second repeated chair stand test immediately after the intervention. However, these effects were not maintained at the 12-month follow-up.

The incidence of falls did not differ between the intervention and control groups. The final analysis included fewer participants than the targeted sample size, suggesting that the trial may be underpowered. However, an examination of the confidence intervals (CI) can offer further insight into this issue [26]. The lower boundary of the CI for the incidence of falls was 0.76 fewer per 100 person-years over 12 months. Moreover, none of the upper boundaries of CIs for balance measures surpassed the pre-set MID values, suggesting that incorporating balance training into PR did not result in meaningful changes for most patients. Taken together, these data imply that power was not the dominant concern in our analyses; even with continued participant recruitment, the trial was unlikely to yield clinically meaningful findings.

The intervention effects on balance measures in this trial align with previous studies that explored exercise-based interventions to reduce fall risk in patients with COPD, although those studies employed varied balance assessment methods [17, 27, 28]. The current trial revealed that integrating balance training with PR significantly enhanced BBS scores immediately after the intervention, while no significant improvement was observed in BESTest and ABC scores. Of note, the mean difference in BBS scores after the intervention was only 1.77 points, and this change may not be large enough to be noticeable to patients or beyond the margin of error, given that the MID for the BBS is reported to be at least 5 points [24]. Considering that a previous trial reported larger and more meaningful differences in balance on these measures after PR, [17] the findings of this larger multi-center trial may indicate that the balance training regimen employed was not sufficient to effect a meaningful enhancement in balance. The balance training components remained largely consistent between the previous and current trials. However, the previous trial incorporated 3 supervised training sessions, whereas the current trial employed 2 supervised training sessions and 1 home session.

The results of our study highlight potential challenges in implementing balance training programs to reduce falls for patients with COPD even though high-certainty evidence supports that such programs effectively prevent falls among older adults in community settings [29]. People with COPD are more likely to reside in deprived or rural areas, which could introduce additional factors influencing fall risk beyond physical limitations [30]. The trial did overlap with the COVID-19 pandemic period, which not only affected the recruitment of eligible participants but also contributed to the low adherence rate and the high proportion of missing data.

Given the low adherence rate to balance training, we need to incorporate related strategies to increase adherence rates or to modify the balance training protocol, such as increasing the number of supervised sessions, the duration of each session, or the overall length of the balance training. Previous research suggests that telerehabilitation programs can enhance adherence to therapeutic exercise, [31] and incorporating specific balance training (e.g., Taiji or Yoga) might be helpful to improve the effects of balance training [29, 32, 33].

After limiting the analysis to only those participants who had at least 70% adherence, we did not observe any significant differences in fall outcomes. Additionally, we did not detect any beneficial effects of balance training on fall outcomes by only including participants with a fall history. The restriction analyses according to compliance data or fall history post-randomization may introduce an imbalance in other effect modifiers or confounding factors, potentially affecting the validity of these analyses. Moreover, these analyses included fewer participants in each group, further warranting caution in interpretation. Further research is necessary to determine the efficacy of balance training on fall outcomes in this population.

Conclusions

Incorporating balance training into PR did not reduce the 12-month fall incidence among high fall risk adults with COPD compared with PR alone. Our observations revealed that while adding balance training to PR could lead to a small improvement in immediate post-intervention balance and lower body strength measures. However, these positive effects were not sustained after the 12-month follow-up period. Future studies should focus on investigating effective strategies for integrating challenging balance training with PR to effectively reduce falls in adults with COPD who are at high risk of falls.

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We thank Professors Paul Stratford (School of Rehabilitation Science, McMaster University; email: stratfor@mcmaster.ca) and Gordon Guyatt (Health Research Methods, Evidence, and Impact, McMaster University; email: guyatt@mcmaster.ca) for helping us choose the statistical models and interpret the results.

Funding

Funding for this study was provided by the Canadian Institutes for Health Research (CIHR). Marla K Beauchamp was supported by an Emerging Research Leader Initiative from the Canadian Respiratory Research Network, an Early Researcher Award from Ministry of Colleges and Universities of Ontario, and a Canada Research Chair in Mobility, Aging, and Chronic Disease. Dina Brooks was supported by a Canada Research Chair in Rehabilitation for Chronic Obstructive Pulmonary Disease (2008–2018) and a National Sanitarium Association Chair in Respiratory Rehabilitation (2019–2024). Samantha Harrison is supported by an NIHR Advanced Fellowship (NIHR300856). The sponsors were not involved in the study’s design, data collection, analysis, interpretation, manuscript writing, or the decision to submit for publication.

Author information

Authors and Affiliations

  1. School of Rehabilitation Science, Faculty of Health Science, McMaster University, IAHS, 1400 Main St. W, Hamilton, ON, L8S 1C7, Canada

    Qiukui Hao, Dina Brooks & Marla K. Beauchamp

  2. Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, ON, Canada

    Dina Brooks, Cindy Ellerton, Roger Goldstein & Marla K. Beauchamp

  3. Department of Physical Therapy, Faculty of Medicine, University of Toronto, Toronto, ON, Canada

    Dina Brooks, Cindy Ellerton & Roger Goldstein

  4. Rehabilitation Sciences Institute, School of Graduate Studies, University of Toronto, Toronto, ON, Canada

    Dina Brooks & Roger Goldstein

  5. Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada

    Dina Brooks & Roger Goldstein

  6. Institute for Breathing and Sleep, Melbourne, VIC, Australia

    Annemarie L. Lee & Anne E. Holland

  7. Department of Physiotherapy, School of Primary and Allied Health Care, Monash University, Melbourne, VIC, Australia

    Annemarie L. Lee & Elizabeth H. Skinner

  8. School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia

    Jennifer A. Alison & Lissa Spencer

  9. Allied Health, Sydney Local Health District, Sydney, Australia

    Jennifer A. Alison

  10. School of Physiotherapy, Faculty of Health, Dalhousie University, Halifax, NS, Canada

    Gail Dechman

  11. Physiotherapy Department, Western Health, Department of Critical Care, The University of Melbourne, Melbourne, VIC, Australia

    Kimberley J. Haines & Elizabeth H. Skinner

  12. School of Health and Life Sciences, Teesside University, Middlesbrough, UK

    Samantha L. Harrison

  13. Department of Physiotherapy, Alfred Health, Melbourne, VIC, Australia

    Anne E. Holland

  14. Respiratory Research, Monash University, Melbourne, VIC, Australia

    Anne E. Holland

  15. Lab3R-Respiratory Research and Rehabilitation Laboratory, School of Health Sciences (ESSUA), Institute of Biomedicine (iBiMED), University of Aveiro, Aveiro, Portugal

    Alda Marques

  16. Department of Physiotherapy, Royal Prince Alfred Hospital, Camperdown, NSW, Australia

    Lissa Spencer

  17. Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada

    Michael K. Stickland

  18. G.F. MacDonald Centre for Lung Health, Covenant Health, Edmonton, AB, Canada

    Michael K. Stickland

  19. Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada

    Pat G. Camp

  20. Centre for Heart Lung Innovation, University of British Columbia, Vancouver, BC, Canada

    Pat G. Camp

  21. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada

    Jinhui Ma

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  1. Qiukui Hao
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Contributions

DB, MB, CE, and RG contributed substantially to the study design and secured funding for this study. QH and JM analyzed the data. QH wrote the first draft of the manuscript. CE, AL, JA, GD, KH, SH, AH, AM, LS, MS, ES, and PC were involved in the data collection, data interpretation, and the revision of the manuscript. MB supervised the data analyses and the writing of the manuscript. All authors critically revised the manuscript. All authors approved the final version of the manuscript.

Corresponding author

Correspondence to Marla K. Beauchamp.

Ethics declarations

Ethics and consent to participate

Nine research sites with outpatient PR programs obtained ethics approval. All participants provided written informed consent to participate in this study. The committees’ names and approval numbers are provided in the following table and Appendix 1.

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Not applicable.

Competing interests

The authors declare no competing interests.

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Hao, Q., Brooks, D., Ellerton, C. et al. Pulmonary rehabilitation with balance training for fall reduction in chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med 24, 408 (2024). https://doi.org/10.1186/s12890-024-03215-2

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  • DOI: https://doi.org/10.1186/s12890-024-03215-2

Keywords

BMC Pulmonary Medicine

ISSN: 1471-2466

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