Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. A growing body of evidence shows that individuals with COPD have important deficits in balance control that may be associated with an increased risk of falls. Pulmonary rehabilitation (PR) is a key therapeutic intervention for individuals with COPD; however, current international guidelines do not include balance training and fall prevention strategies. OBJECTIVE: The primary aim of this trial is to determine the effects of PR with balance training compared to PR with no balance training on the 12-month rate of falls in individuals with COPD. Secondary aims are to determine the effects of the intervention on balance, balance confidence, and functional lower body strength, and to estimate the cost-effectiveness of the program. METHODS: A total of 400 individuals from nine PR centers across Canada, Europe, and Australia will be recruited to participate in a randomized controlled trial. Individuals with COPD who have a self-reported decline in balance, a fall in the last 2 years, or recent near fall will be randomly assigned to an intervention or control group. The intervention group will undergo tailored balance training in addition to PR and will receive a personalized home-based balance program. The control group will receive usual PR and a home program that does not include balance training. All participants will receive monthly phone calls to provide support and collect health care utilization and loss of productivity data. Both groups will receive home visits at 3, 6, and 9 months to ensure proper technique and progression of home exercise programs. The primary outcome will be incidence of falls at 12-month follow-up. Falls will be measured using a standardized definition and recorded using monthly self-report fall diary calendars. Participants will be asked to record falls and time spent performing their home exercise program on the fall diary calendars. Completed calendars will be returned to the research centers in prepaid envelopes each month. Secondary measures collected by a blinded assessor at baseline (pre-PR), post-PR, and 12-month follow-up will include clinical measures of balance, balance confidence, functional lower body strength, and health status. The cost-effectiveness of the intervention group compared with the control group will be evaluated using the incremental cost per number of falls averted and the incremental cost per quality-adjusted life years gained. RESULTS: Recruitment for the study began in January 2017 and is anticipated to be complete by December 2019. Results are expected to be available in 2020. CONCLUSIONS: Findings from this study will improve our understanding of the effectiveness and resource uses of tailored balance training for reducing falls in individuals with COPD. If effective, the intervention represents an opportunity to inform international guidelines and health policy for PR in individuals with COPD who are at risk of falling

Age and Sex Differences in Balance Outcomes among Individuals with Chronic Obstructive Pulmonary Disease (COPD) at Risk of Falls

No previous research has examined age and sex differences in balance outcomes in individuals with chronic obstructive pulmonary disease (COPD) at risk of falls. A secondary analysis of baseline data from an ongoing trial of fall prevention in COPD was conducted. Age and sex differences were analyzed for the Berg Balance scale (BBS), Balance Evaluation System Test (BEST test) and Activities-specific Balance Confidence Scale (ABC). Overall, 223 individuals with COPD were included. Females had higher balance impairments than males [BBS: mean (SD) = 47 (8) vs. 49 (6) points; BEST test: 73 (16) vs. 80 (16) points], and a lower confidence to perform functional activities [ABC = 66 (21) vs. 77 (19)]. Compared to a younger age (50–65years) group, age >65years was moderately associated with poor balance control [BBS (r=− 0.37), BEST test (r=− 0.33)] and weakly with the ABC scale (r=− 0.13). After controlling for the effect of balance risk factors, age, baseline dyspnea index (BDI), and the 6-min walk test (6-MWT) explained 38% of the variability in the BBS; age, sex, BDI, and 6-MWT explained 40% of the variability in the BEST test; And BDI and the 6-MWT explained 44% of the variability in the ABC scale. This study highlights age and sex differences in balance outcomes among individuals with COPD at risk of falls. Recognition of these differences has implications for pulmonary rehabilitation and fall prevention in COPD, particularly among females and older adults.This study was funded by the Canadian Institute of Health Research - CIHR funding reference # PJT 148566.publishe

Validity of the activities-specific balance confidence scale in individuals with chronic obstructive pulmonary disease

Limited research assessed the validity of the Activities-specific Balance Confidence, ABC) Scale in individuals with chronic obstructive pulmonary disease, COPD) at risk of falls. We report on the scale's construct and criterion validity.publishe

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

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.</p

Reflections on the challenges of conducting an international multicentre randomized controlled trial of balance training in addition to pulmonary rehabilitation and its impact on fall incidence in people with COPD

Background: Pulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources. With the recent completion of the Balance Training for Fall Reduction in COPD RCT, we report on the design, implementation, and execution of our trial using project management phases. We also highlight our lessons learned for consideration in future multi-centre rehabilitation trials. Methods: This was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al. in 2010: (1) initiation, (2) planning, (3) execution, and (4) monitoring and controlling. We report descriptive statistics as percentages and counts and summarize our lessons learned. Results: Ten outpatient PR programs in three continents participated. Thirty-one personnel worked on the trial across all sites. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Approximately 1275 patients were screened, 455 (36%) were eligible, 258 (57%) consented, 243 (53%) participated, and 130 (61%) completed the 12-month follow-up assessment. Lessons learned through our experience included (1) ensuring awareness of funder policies and considering the impact on collaborating sites; (2) preparing for the possibility of human resource and program disruptions; (3) anticipating site dropout and having a contingency plan in place; (4) planning and monitoring process measure data before, during, and after trial initiation; (5) ensuring frequent and consistent communication with and between collaborating sites; (6) maximizing features of database platform to ensure data set completeness and controlled data access; and (7) identifying strategies for increasing patient engagement in a high-demand study. Conclusions: We identify seven lessons learned through our experience conducting an international, multicentre rehabilitation-based RCT. These lessons can provide guidance to other trialists conducting studies with similar logistics and may assist with future trial planning and implementation.</p

Balance measures for fall risk screening in community-dwelling older adults with COPD:A longitudinal analysis

Background: Chronic obstructive pulmonary disease (COPD) increases fall risk, but consensus is lacking on suitable balance measures for fall risk screening in this group. We aimed to evaluate the reliability and validity of balance measures for fall risk screening in community-dwelling older adults with COPD. Methods: In a secondary analysis of two studies, participants, aged ≥60 years with COPD and 12-month fall history or balance issues were tracked for 12-month prospective falls. Baseline balance measures – Brief Balance Evaluation Systems Test (Brief BESTest), single leg stance (SLS), Timed Up and Go (TUG), and TUG Dual-Task (TUG-DT) test – were assessed using intra-class correlation (ICC2,1) for reliability, Pearson/Spearman correlation with balance-related factors for convergent validity, t-tests/Wilcoxon rank-sum tests with fall-related and disease-related factors for known-groups validity, and area under the receiver operator characteristic curve (AUC) for predictive validity. Results: Among 174 participants (73 ± 8 years; 86 females) with COPD, all balance measures showed excellent inter-rater and test-retest reliability (ICC2,1 = 0.88–0.97) and moderate convergent validity (r = 0.34–0.77) with related measures. Brief BESTest and SLS test had acceptable known-groups validity (p &lt; 0.05) for 12-month fall history, self-reported balance problems, and gait aid use. TUG test and TUG-DT test discriminated between groups based on COPD severity, supplemental oxygen use, and gait aid use. All measures displayed insufficient predictive validity (AUC&lt;0.70) for 12-month prospective falls. Conclusion: Though all four balance measures demonstrated excellent reliability, they lack accuracy in prospectively predicting falls in community-dwelling older adults with COPD. These measures are best utilized within multi-factorial fall risk assessments for this population.</p

Reflections on the challenges of conducting an international multicentre randomized controlled trial of balance training in addition to pulmonary rehabilitation and its impact on fall incidence in people with COPD

Abstract Background Pulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources. With the recent completion of the Balance Training for Fall Reduction in COPD RCT, we report on the design, implementation, and execution of our trial using project management phases. We also highlight our lessons learned for consideration in future multi-centre rehabilitation trials. Methods This was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al. in 2010: (1) initiation, (2) planning, (3) execution, and (4) monitoring and controlling. We report descriptive statistics as percentages and counts and summarize our lessons learned. Results Ten outpatient PR programs in three continents participated. Thirty-one personnel worked on the trial across all sites. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Approximately 1275 patients were screened, 455 (36%) were eligible, 258 (57%) consented, 243 (53%) participated, and 130 (61%) completed the 12-month follow-up assessment. Lessons learned through our experience included (1) ensuring awareness of funder policies and considering the impact on collaborating sites; (2) preparing for the possibility of human resource and program disruptions; (3) anticipating site dropout and having a contingency plan in place; (4) planning and monitoring process measure data before, during, and after trial initiation; (5) ensuring frequent and consistent communication with and between collaborating sites; (6) maximizing features of database platform to ensure data set completeness and controlled data access; and (7) identifying strategies for increasing patient engagement in a high-demand study. Conclusions We identify seven lessons learned through our experience conducting an international, multicentre rehabilitation-based RCT. These lessons can provide guidance to other trialists conducting studies with similar logistics and may assist with future trial planning and implementation

Reflections on the challenges of conducting an international multicentre randomized controlled trial of balance training in addition to pulmonary rehabilitation and its impact on fall incidence in people with COPD

Abstract Background Pulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources. With the recent completion of the Balance Training for Fall Reduction in COPD RCT, we report on the design, implementation, and execution of our trial using project management phases. We also highlight our lessons learned for consideration in future multi-centre rehabilitation trials. Methods This was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al. in 2010: (1) initiation, (2) planning, (3) execution, and (4) monitoring and controlling. We report descriptive statistics as percentages and counts and summarize our lessons learned. Results Ten outpatient PR programs in three continents participated. Thirty-one personnel worked on the trial across all sites. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Approximately 1275 patients were screened, 455 (36%) were eligible, 258 (57%) consented, 243 (53%) participated, and 130 (61%) completed the 12-month follow-up assessment. Lessons learned through our experience included (1) ensuring awareness of funder policies and considering the impact on collaborating sites; (2) preparing for the possibility of human resource and program disruptions; (3) anticipating site dropout and having a contingency plan in place; (4) planning and monitoring process measure data before, during, and after trial initiation; (5) ensuring frequent and consistent communication with and between collaborating sites; (6) maximizing features of database platform to ensure data set completeness and controlled data access; and (7) identifying strategies for increasing patient engagement in a high-demand study. Conclusions We identify seven lessons learned through our experience conducting an international, multicentre rehabilitation-based RCT. These lessons can provide guidance to other trialists conducting studies with similar logistics and may assist with future trial planning and implementation