Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease

Protocol for a Randomized Controlled Trial

Marla K. Beauchamp, Dina Brooks, Cindy Ellerton, Annemarie Louise Lee, Jennifer Alison, Pat G Camp, Gail Dechman, Kimberley Haines, Samantha L Harrison, Anne Holland, Alda Marques, Rahim Moineddin, Elizabeth H Skinner, Lissa Spencer, Michael K Stickland, Feng Xie, Roger S Goldstein

Research output: Contribution to journalArticleOtherpeer-review

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)
Original languageEnglish
Article numbere228
Number of pages11
JournalJMIR Research Protocols
Volume6
Issue number11
DOIs
Publication statusPublished - Nov 2017

Cite this

Beauchamp, Marla K. ; Brooks, Dina ; Ellerton, Cindy ; Lee, Annemarie Louise ; Alison, Jennifer ; Camp, Pat G ; Dechman, Gail ; Haines, Kimberley ; Harrison, Samantha L ; Holland, Anne ; Marques, Alda ; Moineddin, Rahim ; Skinner, Elizabeth H ; Spencer, Lissa ; Stickland, Michael K ; Xie, Feng ; Goldstein, Roger S. / Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease : Protocol for a Randomized Controlled Trial. In: JMIR Research Protocols. 2017 ; Vol. 6, No. 11.
@article{423db17939df473fb805c9fd8a752ccd,
title = "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)",
author = "Beauchamp, {Marla K.} and Dina Brooks and Cindy Ellerton and Lee, {Annemarie Louise} and Jennifer Alison and Camp, {Pat G} and Gail Dechman and Kimberley Haines and Harrison, {Samantha L} and Anne Holland and Alda Marques and Rahim Moineddin and Skinner, {Elizabeth H} and Lissa Spencer and Stickland, {Michael K} and Feng Xie and Goldstein, {Roger S}",
year = "2017",
month = "11",
doi = "10.2196/resprot.8178",
language = "English",
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Beauchamp, MK, Brooks, D, Ellerton, C, Lee, AL, Alison, J, Camp, PG, Dechman, G, Haines, K, Harrison, SL, Holland, A, Marques, A, Moineddin, R, Skinner, EH, Spencer, L, Stickland, MK, Xie, F & Goldstein, RS 2017, 'Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial', JMIR Research Protocols, vol. 6, no. 11, e228. https://doi.org/10.2196/resprot.8178

Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease : Protocol for a Randomized Controlled Trial. / Beauchamp, Marla K.; Brooks, Dina; Ellerton, Cindy; Lee, Annemarie Louise; Alison, Jennifer; Camp, Pat G; Dechman, Gail; Haines, Kimberley; Harrison, Samantha L; Holland, Anne; Marques, Alda; Moineddin, Rahim; Skinner, Elizabeth H; Spencer, Lissa; Stickland, Michael K; Xie, Feng; Goldstein, Roger S.

In: JMIR Research Protocols, Vol. 6, No. 11, e228, 11.2017.

Research output: Contribution to journalArticleOtherpeer-review

TY - JOUR

T1 - Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease

T2 - Protocol for a Randomized Controlled Trial

AU - Beauchamp, Marla K.

AU - Brooks, Dina

AU - Ellerton, Cindy

AU - Lee, Annemarie Louise

AU - Alison, Jennifer

AU - Camp, Pat G

AU - Dechman, Gail

AU - Haines, Kimberley

AU - Harrison, Samantha L

AU - Holland, Anne

AU - Marques, Alda

AU - Moineddin, Rahim

AU - Skinner, Elizabeth H

AU - Spencer, Lissa

AU - Stickland, Michael K

AU - Xie, Feng

AU - Goldstein, Roger S

PY - 2017/11

Y1 - 2017/11

N2 - 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)

AB - 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)

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DO - 10.2196/resprot.8178

M3 - Article

VL - 6

JO - JMIR Research Protocols

JF - JMIR Research Protocols

SN - 1929-0748

IS - 11

M1 - e228

ER -