NCT Number: NCT02695342
Home Balance Pilot for Fall Reduction in 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.
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Notify MeKey information
Conditions
Age range
60 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Recruitment rate
Time frame: Baseline
Percentage of eligible patients that consent to enroll in the study
-
Retention rate
Time frame: 6 months
Percentage of the sample that complete all 3 outcome assessments
-
Compliance
Time frame: 6 months
Mean number of prescribed exercise sessions completed
Secondary outcomes
-
Berg Balance Scale
Time frame: baseline, 3 months, 6 months
Measure of balance
-
Balance Evaluation Systems Test (BESTest)
Time frame: baseline, 3 months, 6 months
Measure of balance
-
Activity-Specific Balance Confidence questionnaire
Time frame: baseline, 3 months, 6 months
Measure of balance confidence
-
30-second Sit-to-Stand Test
Time frame: baseline 3 months, 6 months
Measure of functional lower body strength
-
Self-reported function (PF-10)
Time frame: baseline, 3 months, 6 months
Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey
Other outcomes
-
Number of falls reported per participant
Time frame: Baseline, 6 months
Fall history will be measured at baseline and prospectively using monthly fall diaries
-
Patient satisfaction questionnaire
Time frame: 6 months
Measure of patient satisfaction
-
Adverse events
Time frame: 6 months
Adverse event history will be tracked
Sponsors and collaborators
Lead sponsor
McMaster University
Other
Collaborators
- West Park Healthcare Centre
Registry information
Official study title
Pilot Study of a Tailored Home Balance Exercise Program for Reducing Falls in Older Adults With COPD
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Mar 1, 2016
- Registry last updated
- Apr 26, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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