Balance Training for Fall Reduction in COPD

NCT02995681 | Terminated DMC

• 1 other identifier: 16-018-WP
• Study Type: interventional
• Target: 258
• Locations: 4 countries
• Sites: 10

Brief Summary

People living with Chronic Obstructive Pulmonary Disease (COPD) have problems with their balance and a high incidence of falls compared to those of a similar age. Pulmonary rehabilitation is recommended for people with COPD, however, these training programs do not typically include balance training or fall prevention strategies. In this study, patients with COPD who report problems with their balance or have had a fall in the last two years will be assigned to a treatment group (balance training plus pulmonary rehabilitation) or control group (standard pulmonary rehabilitation). We will record the number of falls using monthly diaries and evaluate patient's balance, strength, confidence and quality of life.

Conditions

Copd; Fall Patients

Keywords

COPD; Falls; Balance training

Outcome Measures

Primary Outcomes (1)

• Number of falls

  Number of falls will be measured using monthly falls diaries

  12 months

Secondary Outcomes (5)

• Berg Balance Scale

  Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months

• Balance Evaluation Systems Test (BESTest)

  Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months

• Activities Specific Balance Confidence Scale

  Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months

• 30 Second Repeated Chair Stand Test

  Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months

• European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)

  Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months

Other Outcomes (2)

• Baseline Dyspnea Index

  Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months

• Falls Risk for Older People - Community Setting (FROP-Com)

  Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months

Study Arms (2)

Pulmonary rehab and balance training

EXPERIMENTAL

The intervention group will receive standard pulmonary rehab plus additional balance training.

Other: Balance training; Other: Pulmonary rehab

Pulmonary rehab

ACTIVE COMPARATOR

The control group will receive pulmonary rehab only and a pulmonary rehab home program (walking and lower extremity resistance exercises) upon discharge from pulmonary. They will also receive the same monthly phone calls and three home visits at three, six and nine months to ensure proper technique and progression.

Other: Pulmonary rehab

Interventions

Balance training OTHER

Balance exercises will include: functional lower extremity training, gait training under challenging conditions and training to increase stability during changes in body positions.

Pulmonary rehab and balance training

Pulmonary rehab OTHER

Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.

Pulmonary rehab; Pulmonary rehab and balance training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a physician diagnosis of COPD based on GOLD criteria; a self-reported decline in balance, a fall within the last two years or a recent near fall; and an ability to provide written informed consent

You may not qualify if:

• severe cognitive impairment (dementia, neurological condition) an inability to communicate because of language skills (aphasia, non-English speaking), or evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g. cerebrovascular accident, Parkinson's Disease, amputation) and may jeopardize their safety or influence their balance.

Sponsors & Collaborators

• West Park Healthcare Centre: lead
• University of British Columbia: collaborator
• Dalhousie University: collaborator
• University of Alberta: collaborator
• University of Ottawa: collaborator
• Teesside University: collaborator
• University of Sydney: collaborator
• Aveiro University: collaborator
• University of Toronto: collaborator
• La Trobe University: collaborator

Study Sites (10)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Western Health

Saint Albans, Victoria, 3021, Australia

Location

G.F. Macdonald Centre for Lung Health

Edmonton, Alberta, T5K 0L4, Canada

Location

St. Paul's Pulmonary Rehab Program

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Colchester East Hants Health Authority

Truro, Nova Scotia, B2N 4Z9, Canada

Location

Ottawa Hospital Rehabilitation Centre

Ottawa, Ontario, K1H 8M2, Canada

Location

West Park Healthcare Centre

Toronto, Ontario, M6M2J5, Canada

Location

School of Health Sciences, University of Aveiro

Aveiro, 3810-193, Portugal

Location

James Cook University Hospital

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

Location

Related Publications (3)

• Nguyen KT, Brooks D, Macedo LG, Ellerton C, Goldstein RS, Alison J, Dechman G, Harrison S, Holland AE, Lee A, Marques A, Spencer L, Stickland MK, Skinner EH, Haines KJ, Beauchamp MK. Development of a clinical prediction model for falls in individuals with COPD. BMJ Open Respir Res. 2025 Dec 25;12(1):e002556. doi: 10.1136/bmjresp-2024-002556.

  PMID: 41448796 DERIVED

• Hao Q, Brooks D, Ellerton C, Goldstein R, Lee AL, Alison JA, Dechman G, Haines KJ, Harrison SL, Holland AE, Marques A, Spencer L, Stickland MK, Skinner EH, Camp PG, Ma J, Beauchamp MK. Pulmonary rehabilitation with balance training for fall reduction in chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med. 2024 Aug 24;24(1):408. doi: 10.1186/s12890-024-03215-2.

  PMID: 39182033 DERIVED

• Beauchamp MK, Brooks D, Ellerton C, Lee A, Alison J, Camp PG, Dechman G, Haines K, Harrison SL, Holland AE, Marques A, Moineddin R, Skinner EH, Spencer L, Stickland MK, Xie F, Goldstein RS. Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Nov 20;6(11):e228. doi: 10.2196/resprot.8178.

  PMID: 29158206 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dina Brooks, PhD

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

• Roger Goldstein, MD

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

• Marla Beauchamp, PhD

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respirologist

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); PT (1); AU (3); CA (5)