Home Balance Pilot for Fall Reduction in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695342
• Other study ID #: Labarge-20004484
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Home balance exercise program

Locations

Country	Name	City	State
Canada	Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	West Park Healthcare Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of falls reported per participant	Fall history will be measured at baseline and prospectively using monthly fall diaries	Baseline, 6 months
Other	Patient satisfaction questionnaire	Measure of patient satisfaction	6 months
Other	Adverse events	Adverse event history will be tracked	6 months
Primary	Recruitment rate	Percentage of eligible patients that consent to enroll in the study	Baseline
Primary	Retention rate	Percentage of the sample that complete all 3 outcome assessments	6 months
Primary	Compliance	Mean number of prescribed exercise sessions completed	6 months
Secondary	Berg Balance Scale	Measure of balance	baseline, 3 months, 6 months
Secondary	Balance Evaluation Systems Test (BESTest)	Measure of balance	baseline, 3 months, 6 months
Secondary	Activity-Specific Balance Confidence questionnaire	Measure of balance confidence	baseline, 3 months, 6 months
Secondary	30-second Sit-to-Stand Test	Measure of functional lower body strength	baseline 3 months, 6 months
Secondary	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