Home Balance Pilot for Fall Reduction in COPD

NCT02695342 | Completed

• 1 other identifier: Labarge-20004484
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Balance; Falls; Exercise; COPD

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Percentage of eligible patients that consent to enroll in the study

  Baseline

• Retention rate

  Percentage of the sample that complete all 3 outcome assessments

  6 months

• Compliance

  Mean number of prescribed exercise sessions completed

  6 months

Secondary Outcomes (5)

• Berg Balance Scale

  baseline, 3 months, 6 months

• Balance Evaluation Systems Test (BESTest)

  baseline, 3 months, 6 months

• Activity-Specific Balance Confidence questionnaire

  baseline, 3 months, 6 months

• 30-second Sit-to-Stand Test

  baseline 3 months, 6 months

• Self-reported function (PF-10)

  baseline, 3 months, 6 months

Other Outcomes (3)

• Number of falls reported per participant

  Baseline, 6 months

• Patient satisfaction questionnaire

  6 months

• Adverse events

  6 months

Study Arms (1)

Home balance exercise program

EXPERIMENTAL

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.

Behavioral: Home balance exercise program

Interventions

Home balance exercise program BEHAVIORAL

Home balance exercise program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• West Park Healthcare Centre: collaborator

Study Sites (2)

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

Hamilton, Ontario, L8N 4A6, Canada

Location

West Park Healthcare Centre

Toronto, Ontario, M6M 2J6, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marla K Beauchamp, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 1, 2016
• Study Start: March 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)