Home Balance Pilot for Fall Reduction in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02695342
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : July 21, 2017
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

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 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 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: 3 months, 6 months ]
  2. Balance Evaluation Systems Test (BESTest) [ Time Frame: 3 months, 6 months ]
  3. Activity-Specific Balance Confidence questionnaire [ Time Frame: 3 months, 6 months ]
  4. Functional strength [ Time Frame: 3 months, 6 months ]
    30 seconds sit-to-stand test

  5. Self-reported function (PF-10) [ Time Frame: 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 ]
  3. Adverse events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT02695342

Contact: Marla K Beauchamp, PhD 4165747065

Canada, Ontario
West Park Healthcare Centre Recruiting
Toronto, Ontario, Canada, M6M2E6
Contact: Marla K Beauchamp, PhD    4165747065   
Contact: Tamara Araujo    416-243-3600 ext 2518   
Sponsors and Collaborators
McMaster University
West Park Healthcare Centre
Principal Investigator: Marla K Beauchamp, PhD McMaster University

Additional Information:
Responsible Party: McMaster University Identifier: NCT02695342     History of Changes
Other Study ID Numbers: Labarge-20004484
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by McMaster University:

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