Home Balance Pilot for Fall Reduction in COPD

Pilot Study of a Tailored Home Balance Exercise Program for Reducing Falls in Older Adults With COPD

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Behavioral: Home balance exercise program

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
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton
    • Toronto, Ontario, Canada, M6M 2J6
      • West Park Healthcare Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Percentage of eligible patients that consent to enroll in the study	Baseline
Retention rate	Percentage of the sample that complete all 3 outcome assessments	6 months
Compliance	Mean number of prescribed exercise sessions completed	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	Measure of balance	baseline, 3 months, 6 months
Balance Evaluation Systems Test (BESTest)	Measure of balance	baseline, 3 months, 6 months
Activity-Specific Balance Confidence questionnaire	Measure of balance confidence	baseline, 3 months, 6 months
30-second Sit-to-Stand Test	Measure of functional lower body strength	baseline 3 months, 6 months
Self-reported function (PF-10)	Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey	baseline, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of falls reported per participant	Fall history will be measured at baseline and prospectively using monthly fall diaries	Baseline, 6 months
Patient satisfaction questionnaire	Measure of patient satisfaction	6 months
Adverse events	Adverse event history will be tracked	6 months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: West Park Healthcare Centre
• Investigators: Principal Investigator: Marla K Beauchamp, PhD, McMaster University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 24, 2016
• First Posted (Estimate): March 1, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Balance; COPD; Falls
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Labarge-20004484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No