Clinical trial NCT02695342: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Balance
Falls
Exercise
COPD
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: West Park Healthcare Centre
First posted: 2016-03-01
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
measure: Retention rate
timeFrame: 6 months
measure: Compliance
timeFrame: 6 months
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: baseline, 3 months, 6 months
measure: Balance Evaluation Systems Test (BESTest)
timeFrame: baseline, 3 months, 6 months
measure: Activity-Specific Balance Confidence questionnaire
timeFrame: baseline, 3 months, 6 months
measure: 30-second Sit-to-Stand Test
timeFrame: baseline 3 months, 6 months
measure: Self-reported function (PF-10)
timeFrame: baseline, 3 months, 6 months
Other outcomes:
measure: Number of falls reported per participant
timeFrame: Baseline, 6 months
measure: Patient satisfaction questionnaire
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Locations:
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Marla K Beauchamp, PhD
role: PRINCIPAL_INVESTIGATOR
References: