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Home Balance Pilot for Fall Reduction in COPD

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ClinicalTrials.gov Identifier: NCT02695342
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
West Park Healthcare Centre
Information provided by (Responsible Party):
McMaster University

Brief Summary:
There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary effects of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: Home balance exercise program Not Applicable

Detailed Description:

Chronic obstructive pulmonary disease (COPD) is highly prevalent among older adults and is a leading cause of death, disability and hospitalization in Canada. There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary efficacy of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.

The primary objective of this pilot study is to determine the feasibility of a tailored home balance intervention for older adults with COPD in terms of recruitment, retention and adherence. The secondary objective is to examine the within-subject effects of the home-balance intervention on intermediate outcomes linked to falls including balance, functional strength and self-reported disability.

Thirty-five older adults with COPD will be recruited from respirology clinics at West Park Healthcare Centre (Toronto) and the Firestone Institute for Respiratory Health (Hamilton) to participate in a single-group, non-randomized clinical trial. Eligible participants will be enrolled in a 6-month balance home exercise intervention. The home program will be supervised by a physiotherapist and outcome measures will be collected at home at baseline, 3- and 6-months by a research assistant not involved in the intervention.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of a Tailored Home Balance Exercise Program for Reducing Falls in Older Adults With COPD
Study Start Date : March 1, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home balance exercise program
The home-based exercise program will be tailored to address the underlying balance deficits in COPD and individualized according to each participant's ability. Physiotherapists will teach the program in four home visits over the first 6 weeks of the study; in the event of an exacerbation, a fifth visit will be provided to modify the program. Participants will be given an exercise DVD (with portable player), and will be instructed to perform the program 3 times/week for 6 months. Therapists will provide bi-monthly telephone support.
Behavioral: Home balance exercise program



Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: Baseline ]
    Percentage of eligible patients that consent to enroll in the study

  2. Retention rate [ Time Frame: 6 months ]
    Percentage of the sample that complete all 3 outcome assessments

  3. Compliance [ Time Frame: 6 months ]
    Mean number of prescribed exercise sessions completed


Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: baseline, 3 months, 6 months ]
    Measure of balance

  2. Balance Evaluation Systems Test (BESTest) [ Time Frame: baseline, 3 months, 6 months ]
    Measure of balance

  3. Activity-Specific Balance Confidence questionnaire [ Time Frame: baseline, 3 months, 6 months ]
    Measure of balance confidence

  4. 30-second Sit-to-Stand Test [ Time Frame: baseline 3 months, 6 months ]
    Measure of functional lower body strength

  5. Self-reported function (PF-10) [ Time Frame: baseline, 3 months, 6 months ]
    Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey


Other Outcome Measures:
  1. Number of falls reported per participant [ Time Frame: Baseline, 6 months ]
    Fall history will be measured at baseline and prospectively using monthly fall diaries

  2. Patient satisfaction questionnaire [ Time Frame: 6 months ]
    Measure of patient satisfaction

  3. Adverse events [ Time Frame: 6 months ]
    Adverse event history will be tracked



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a clinical diagnosis of COPD;
  • age ≥ 60 yrs;
  • a history of 1 or more falls in the previous year;
  • ability to provide written informed consent.

Exclusion Criteria:

  • inability to communicate in English;
  • history of significant cardiovascular disease;
  • marked decrease in arterial oxygen saturation at rest or during previous assessments of exercise capacity;
  • severe cognitive impairment;
  • evidence of a condition that severely limits mobility and may jeopardize safety;
  • completion of a course of rehabilitation in the last 6 months or on a wait list for admission to rehabilitation.

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): NCT02695342


Contacts
Contact: Marla K Beauchamp, PhD 4165747065 beaucm1@mcmaster.ca

Locations
Canada, Ontario
Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Marla K Beauchamp, PhD    416-574-7065    beaucm1@mcmaster.ca   
Contact: Cindy Ellerton, MSc    416-543-1659    ellertoc@mcmaster.ca   
Sub-Investigator: Stuart Pugsley, MD         
Sub-Investigator: Julie Richardson, PhD         
West Park Healthcare Centre Recruiting
Toronto, Ontario, Canada, M6M 2J6
Contact: Marla K Beauchamp, PhD    4165747065    beaucm1@mcmaster.ca   
Contact: Cindy Ellerton    416-243-3600 ext 2653    c.ellerton@utoronto.ca   
Sub-Investigator: Dina Brooks, PhD         
Sub-Investigator: Roger Goldstein, MD         
Sponsors and Collaborators
McMaster University
West Park Healthcare Centre
Investigators
Principal Investigator: Marla K Beauchamp, PhD McMaster University

Additional Information:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02695342     History of Changes
Other Study ID Numbers: Labarge-20004484
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by McMaster University:
Balance
Falls
Exercise
COPD

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive