Home Balance Pilot for Fall Reduction in COPD

NCT ID: NCT02695342

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Home balance exercise program

Intervention Type BEHAVIORAL

Interventions

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Home balance exercise program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Park Healthcare Centre

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marla K Beauchamp, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

West Park Healthcare Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Labarge-20004484

Identifier Type: -

Identifier Source: org_study_id

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