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Balance Training for Fall Reduction in COPD

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ClinicalTrials.gov Identifier: NCT02995681
Recruitment Status : Not yet recruiting
First Posted : December 16, 2016
Last Update Posted : December 16, 2016
Sponsor:
Collaborators:
University of British Columbia
Dalhousie University
University of Alberta
University of Ottawa
Teesside University
University of Sydney
La Trobe University
Aveiro University
University of Toronto
Information provided by (Responsible Party):
Roger Goldstein, West Park Healthcare Centre

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.

Condition or disease Intervention/treatment Phase
Copd Fall Patients Other: Balance training Other: Pulmonary rehab Not Applicable

Detailed Description:

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality in Canada. In addition to lung impairment, secondary effects of the disease are well established including impairments in muscle function and exercise capacity. However, individuals with COPD also have marked deficits in balance and an increased risk of falls with a 3-5 times higher annual fall rate than those of similar age. The underlying mechanisms remain unclear, but several factors have been implicated including decreased physical activity, muscle weakness, altered trunk mechanics, comorbidities, hypoxemia and proprioceptive deficits. Given this unique impairment profile, tailored approaches to balance training and fall prevention are needed in COPD.

Pulmonary rehabilitation (PR) is an integral therapeutic intervention for individuals with COPD. The program typically consists of supervised exercise, disease-specific education, and psychological and social support. Balance training and fall prevention strategies are not currently included in international guidelines for PR and few programs include any balance assessment. We have previously shown that the exercise component of traditional PR has minimal effect on measures of balance and fall risk. We then conducted an RCT to examine the effects of balance training alongside PR, which specifically addressed the profile of balance deficits we had identified in COPD. Tailored balance training alongside PR results in clinically important improvements in balance performance compared to PR alone. Given these results, we now have the opportunity to build on our existing experience to test the effect of the intervention on falls.

The purpose of this study is to establish the efficacy of a tailored balance exercise program for reducing falls in individuals with COPD enrolled in PR. If participation in tailored balance training decreases falls compared to usual PR, this approach will represent an innovative and potential cost-saving strategy to prevent falls and reduce associated healthcare utilization in COPD. Our results will be relevant for guiding clinical and policy-based decision making, given the large population of individuals with COPD and the potential for severe consequences of falls in this population.

The primary objective of this study is to evaluate the long-term effects of tailored balance exercise on the rate of falls in individuals with COPD enrolled in PR. Secondary objectives are to determine 1) the long-term effects of the program on measures of balance, balance confidence and muscle strength; and 2) the cost-utility of the program.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Balance Training for Fall Reduction in Individuals With COPD
Study Start Date : January 2017
Estimated Primary Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Rehabilitation

Arm Intervention/treatment
Experimental: Pulmonary rehab and balance training
The intervention group will receive standard pulmonary rehab plus additional balance training.
Other: Balance training
Balance exercises will include: functional lower extremity training, gait training under challenging conditions and training to increase stability during changes in body positions.

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

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




Primary Outcome Measures :
  1. Number of falls [ Time Frame: 12 months ]
    Number of falls will be measured using monthly falls diaries


Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months ]
    Clinical measure of balance

  2. Balance Evaluation Systems Test (BESTest) [ Time Frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months ]
    Clinical measure of balance

  3. Activities Specific Balance Confidence Scale [ Time Frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months ]
    Balance confidence questionnaire

  4. 30 Second Repeated Chair Stand Test [ Time Frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months ]
    Functional lower body strength test

  5. European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L) [ Time Frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months ]
    Health status questionnaire


Other Outcome Measures:
  1. Baseline Dyspnea Index [ Time Frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months ]
    Descriptive measure of shortness of breath

  2. Falls Risk for Older People - Community Setting (FROP-Com) [ Time Frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months ]
    Descriptive measure of falls risk in community dwelling older people



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995681


Contacts
Contact: Dina Brooks, PhD 416-978-1739 dina.brooks@utoronto.ca
Contact: Cindy Ellerton, MSc 416-243-3600 ext 2653 c.ellerton@utoronto.ca

Locations
Australia, New South Wales
Royal Prince Alfred Hospital Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Jennifer Alison, PhD    +61 2 9351 9371    jennifer.alison@sydney.edu.au   
Contact: Lissa Spencer, PhD       david.g.spencer@bigpond.com   
Sub-Investigator: Jennifer Alison, PhD         
Sub-Investigator: Lissa Spencer, PhD         
Australia, Victoria
Alfred Health Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Annemarie Lee, PhD    +61 03 94795676    A.Lee3@LaTrobe.edu.au   
Sub-Investigator: Annemarie Lee, PhD         
Sub-Investigator: Anne Holland, PhD         
Western Health Not yet recruiting
Saint Albans, Victoria, Australia, 3021
Contact: Kimberley Haines, PhD    0401 288 292    kimberley.haines@wh.org.au   
Sub-Investigator: Kimberley Haines, PhD         
Canada, Alberta
G.F. Macdonald Centre for Lung Health Not yet recruiting
Edmonton, Alberta, Canada, T5K 0L4
Contact: Michael Stickland, PhD    780-492-1657    michael.stickland@ualberta.ca   
Sub-Investigator: Michael Stickland, PhD         
Canada, British Columbia
St. Paul's Pulmonary Rehab Program Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Pat Camp, PhD    604-806-9144    pat.camp@hli.ubc.ca   
Sub-Investigator: Pat Camp, PhD         
Canada, Nova Scotia
Colchester East Hants Health Authority Not yet recruiting
Truro, Nova Scotia, Canada, B2N 4Z9
Contact: Gail Dechman, PhD    902-494-2734    gail.dechman@dal.ca   
Sub-Investigator: Gail Dechman, PhD         
Canada, Ontario
Ottawa Hospital Rehabilitation Centre Not yet recruiting
Ottawa, Ontario, Canada, K1H 8M2
Contact: Jacqueline Sandoz, MD, PhD       jssandoz@yahoo.com   
Sub-Investigator: Jacqueline Sandoz, MD, PhD         
West Park Healthcare Centre Not yet recruiting
Toronto, Ontario, Canada, M6M2J5
Contact: Dina Brooks, PhD    416-978-1739    dina.brooks@utoronto.ca   
Contact: Cindy Ellerton, MSc    416-243-3600 ext 2653    c.ellerton@utoronto.ca   
Principal Investigator: Dina Brooks, PhD         
Principal Investigator: Roger Goldstein, MD         
Principal Investigator: Marla Beauchamp, PhD         
Portugal
School of Health Sciences, University of Aveiro Not yet recruiting
Aveiro, Portugal, 3810-193
Contact: Alda Marques, PhD    +351 234 372 462 ext 27132    amarques@ua.pt   
Sub-Investigator: Alda Marques, PhD         
United Kingdom
James Cook University Hospital Not yet recruiting
Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
Contact: Samantha Harrison, PhD    01642 384100    s.l.harrison@tees.ac.uk   
Sub-Investigator: Samantha Harrison, PhD         
Sponsors and Collaborators
West Park Healthcare Centre
University of British Columbia
Dalhousie University
University of Alberta
University of Ottawa
Teesside University
University of Sydney
La Trobe University
Aveiro University
University of Toronto
Investigators
Principal Investigator: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roger Goldstein, Respirologist, West Park Healthcare Centre
ClinicalTrials.gov Identifier: NCT02995681     History of Changes
Other Study ID Numbers: 16-018-WP
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Roger Goldstein, West Park Healthcare Centre:
COPD
Falls
Balance training