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Completed

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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Key information

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

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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

Home balance exercise program

Behavioral

Primary outcomes

  1. Recruitment rate

    Time frame: Baseline

    Percentage of eligible patients that consent to enroll in the study

  2. Retention rate

    Time frame: 6 months

    Percentage of the sample that complete all 3 outcome assessments

  3. Compliance

    Time frame: 6 months

    Mean number of prescribed exercise sessions completed

Secondary outcomes

  1. Berg Balance Scale

    Time frame: baseline, 3 months, 6 months

    Measure of balance

  2. Balance Evaluation Systems Test (BESTest)

    Time frame: baseline, 3 months, 6 months

    Measure of balance

  3. Activity-Specific Balance Confidence questionnaire

    Time frame: baseline, 3 months, 6 months

    Measure of balance confidence

  4. 30-second Sit-to-Stand Test

    Time frame: baseline 3 months, 6 months

    Measure of functional lower body strength

  5. 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

  1. Number of falls reported per participant

    Time frame: Baseline, 6 months

    Fall history will be measured at baseline and prospectively using monthly fall diaries

  2. Patient satisfaction questionnaire

    Time frame: 6 months

    Measure of patient satisfaction

  3. 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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