Dataset Information

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

ABSTRACT: 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. TRIAL REGISTRATION:ClinicalTrials.gov NCT02995681; https://clinicaltrials.gov/ct2/show/NCT02995681 (Archived by WebCite at http://www.webcitation.org/6ukhxgAsg).

SUBMITTER: Beauchamp MK

PROVIDER: S-EPMC5715200 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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

Beauchamp Marla K MK Brooks Dina D Ellerton Cindy C Lee Annemarie A Alison Jennifer J Camp Pat G PG Dechman Gail G Haines Kimberley K Harrison Samantha L SL Holland Anne E AE Marques Alda A Moineddin Rahim R Skinner Elizabeth H EH Spencer Lissa L Stickland Michael K MK Xie Feng F Goldstein Roger S RS

JMIR research protocols 20171120 11

<h4>Background</h4>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.<h4>Objective</h4>The pr ...[more]

PMID: 29158206

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Project description:Background and objectivesAvailable 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.MethodsWe 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.ResultsOf 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).ConclusionsPR 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 registrationThe study was registered with ClinicalTrials.gov (NCT02995681) on 14/12/2016.

Project description:BackgroundWe have recently demonstrated the efficacy of balance training in addition to Pulmonary Rehabilitation (PR) at improving measures of balance associated with an increased risk of falls in individuals with Chronic Obstructive Pulmonary Disease (COPD). Few knowledge translation (KT) projects have been conducted in rehabilitation settings. The goal of this study was to translate lessons learnt from efficacy studies of balance training into a sustainable clinical service.MethodsHealth care professionals (HCPs) responsible for delivering PR were given an hour of instruction on the principles and practical application of balance training and the researchers offered advice regarding; prescription, progression and practical demonstrations during the first week. Balance training was incorporated three times a week into conventional PR programs. Following the program, HCPs participated in a focus group exploring their experiences of delivering balance training alongside PR. Service users completed satisfaction surveys as well as standardized measures of balance control. At six month follow-up, the sustainability of balance training was explored.ResultsHCPs considered the training to be effective at improving balance and the support provided by the researchers was viewed as helpful. HCPs identified a number of strategies to facilitate balance training within PR, including; training twice a week, incorporating an interval training program for everyone enrolled in PR, providing visual aids to training and promoting independence by; providing a set program, considering the environment and initiating a home-based exercise program early. Nineteen service users completed the balance training [ten male mean (SD) age 73 (6) y]. Sixteen patients (84%) enjoyed balance training and reported that it helped them with everyday activities and 18 (95%) indicated their wish to continue with it. Scores on balance measures improved following PR that included balance training (all p < 0.05). At six month follow-up balance training is being routinely assessed and delivered as part of standardised PR.ConclusionsImplementing balance training into PR programs, with support and training for HCPs, is feasible, effective and sustainable.Trail registrationClinical Trials ID: NCT02080442 (05/03/2014).

Project description:BackgroundChronic obstructive pulmonary disease (COPD) is characterised mainly by exertional dyspnoea, which may lead to activity reduction. Pulmonary rehabilitation (PR) is considered capable of mitigating these impairments. However, access to PR is limited to specialised centres, especially during the coronavirus disease 2019 pandemic. Moreover, low-cost home rehabilitation programmes have non-individualised prescriptions, which might lead to inconsistent clinical effects in patients with COPD. Therefore, it is important to develop new, low-cost protocols involving individualised prescriptions and staff supervision.MethodsThis is a descriptive protocol for a randomised controlled study at the Grade III A Hospital in Tianjin. The sample size was calculated according to a described formula. Fifty-six participants will be selected and randomly allocated into two groups: (I) control (traditional PR training, medication, and nursing interventions); and (II) intervention [PR training in the hospital and at home by the Cardiopulmonary Rehabilitation System Management Platform (CSM)]. The protocol will be performed twice a week for 8 consecutive weeks in the outpatient clinic, and the training will be performed by the application of the CSM system in the final 6 months of the trial. The study will assess lung function and physical fitness and analyse the scores of the modified Medical Research Council Dyspnoea Scale, the COPD assessment test, the International Classification of Functioning, Disability, and Health, and the 6-minute walk test before and after the training protocol. Comparison of differences will be performed using repeated measures analysis of variance, a linear mixed effects analysis, or a non-parametric test, which will include only participants who completed all outcome measures and followed the intervention protocol. The study results will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.DiscussionThe new, low-cost supervised rehabilitation programmes are expected to present positive results, making PR programmes more accessible and effective for patients with COPD.Trial registrationThe study was registered in the Chinese Clinical Trial Registry: ChiCTR2000040723.

Project description:IntroductionInspiratory muscle training (IMT) has been applied during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD). However, it remains unclear if the addition of IMT to a general exercise training programme leads to additional clinically relevant improvements in patients with COPD. In this study, we will investigate whether the addition of IMT to a general exercise training programme improves 6 min walking distance, health-related quality of life, daily physical activity and inspiratory muscle function in patients with COPD with inspiratory muscle weakness.Methods and analysisPatients with COPD (n=170) with inspiratory muscle weakness (Pi,max <60 cm H2O or <50%pred) will be recruited to a multicentre randomised placebo controlled trial of IMT and allocated into one of the two groups. Patients in both groups will follow a 3 month general exercise training programme, in combination with home-based IMT. IMT will be performed with a recently developed device (POWERbreathe KH1). This device applies an inspiratory load that is provided by an electronically controlled valve (variable flow resistive load). The intervention group (n=85) will undertake an IMT programme at a high intensity (?50% of their Pi,max), whereas the placebo group (n=85) will undertake IMT at a low training intensity (?10% of Pi,max). Total daily IMT time for both groups will be 21 min (6 cycles of 30 breaths). Improvement in the 6 min walking distance will be the primary outcome. Inspiratory muscle function, health-related quality of life and daily physical activity will be assessed as secondary outcomes.Ethics and disseminationEthics approval has been obtained from relevant centre committees and the study has been registered in a publicly accessible clinical trial database. The results will be easily interpretable and should immediately be communicated to healthcare providers, patients and the general public.ResultsThis can be incorporated into evidence-based treatment recommendations for clinical practice.ClinicaltrialsgovNCT01397396.

Dataset Information

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

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

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