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Home Balance Pilot for Fall Reduction in COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Home balance exercise program
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Balance, Falls, Exercise, COPD

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton
  • West Park Healthcare Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home balance exercise program

Arm Description

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.

Outcomes

Primary Outcome Measures

Recruitment rate
Percentage of eligible patients that consent to enroll in the study
Retention rate
Percentage of the sample that complete all 3 outcome assessments
Compliance
Mean number of prescribed exercise sessions completed

Secondary Outcome Measures

Berg Balance Scale
Measure of balance
Balance Evaluation Systems Test (BESTest)
Measure of balance
Activity-Specific Balance Confidence questionnaire
Measure of balance confidence
30-second Sit-to-Stand Test
Measure of functional lower body strength
Self-reported function (PF-10)
Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey

Full Information

First Posted
February 22, 2016
Last Updated
April 24, 2023
Sponsor
McMaster University
Collaborators
West Park Healthcare Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02695342
Brief Title
Home Balance Pilot for Fall Reduction in COPD
Official Title
Pilot Study of a Tailored Home Balance Exercise Program for Reducing Falls in Older Adults With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
West Park Healthcare Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Balance, Falls, Exercise, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home balance exercise program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home balance exercise program
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Percentage of eligible patients that consent to enroll in the study
Time Frame
Baseline
Title
Retention rate
Description
Percentage of the sample that complete all 3 outcome assessments
Time Frame
6 months
Title
Compliance
Description
Mean number of prescribed exercise sessions completed
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
Measure of balance
Time Frame
baseline, 3 months, 6 months
Title
Balance Evaluation Systems Test (BESTest)
Description
Measure of balance
Time Frame
baseline, 3 months, 6 months
Title
Activity-Specific Balance Confidence questionnaire
Description
Measure of balance confidence
Time Frame
baseline, 3 months, 6 months
Title
30-second Sit-to-Stand Test
Description
Measure of functional lower body strength
Time Frame
baseline 3 months, 6 months
Title
Self-reported function (PF-10)
Description
Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey
Time Frame
baseline, 3 months, 6 months
Other Pre-specified Outcome Measures:
Title
Number of falls reported per participant
Description
Fall history will be measured at baseline and prospectively using monthly fall diaries
Time Frame
Baseline, 6 months
Title
Patient satisfaction questionnaire
Description
Measure of patient satisfaction
Time Frame
6 months
Title
Adverse events
Description
Adverse event history will be tracked
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marla K Beauchamp, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Home Balance Pilot for Fall Reduction in COPD

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