Fall Risk Assessment in COPD

Completed

• Conditions: Pulmonary Disease; COPD

• Registration Number: NCT03229473
• Lead Sponsor: McMaster University

Brief Summary

People with chronic obstructive pulmonary disease (COPD) have balance problems and are at risk of falling. New guidelines recommend balance assessment be included in pulmonary rehabilitation (PR) however no specific tests are recommended. Our goal is to determine the best balance test for identifying COPD patients who are at risk of falling. In this study, COPD patients who report balance problems or falling in the last year will participate in a testing session. Balance, balance confidence, lower body strength, exercise tolerance and perceived physical limitations will be assessed. The number of falls over the following year will be recorded using monthly calendars.

Detailed Description

COPD is a leading cause of death, disability and hospitalization in Canada. In addition to the primary lung impairment, secondary effects of the disease are well established including impairments in muscle function, mobility and exercise capacity. Individuals with COPD also have marked deficits in balance and an increased risk of falls.

The updated American Thoracic Society/European Respiratory Society Statement on PR recommended expanding the scope of outcome assessment in COPD to include balance however no specific tests are suggested. An examination of brief balance measures feasible for fall risk screening has not been conducted. Such information will inform clinicians as to those most likely to benefit from targeted intervention. This study aims to determine the optimal balance measure for identifying patients with COPD who are high risk for falling.

The specific objectives of the study are to: 1) Investigate the construct validity (convergent and known-groups) and reliability (inter-rater and test-retest) of three short balance screening measures in people with COPD; 2) Investigate the predictive validity of the balance screening tests for falls; and 3) Identify cut-off scores for identifying fallers with COPD on the balance screening tool with the strongest psychometric properties.

One hundred and twenty individuals with COPD will be recruited from two sites. Upon enrolment, participants will undergo a physical assessment session measuring balance, functional lower body strength and exercise tolerance. Participants will also complete questionnaires of balance confidence, perceived physical function limitations, fall risk, dyspnea, global cognitive impairment and executive function. Participants will then be followed for 12 months to measure incidence of falls.

To assess inter-rater reliability of the primary measures, two raters will simultaneously administer the balance tests with a subset of the first 32 subjects to agree to participate in this study. This subset will also be asked to return for repeat testing two-three days after the baseline assessment to assess test-retest reliability.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-25
• Study Start: 2017-09-14
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• diagnosis of COPD according to GOLD guidelines
• history of one or more falls in the previous year or a self-reported problem with balance/fear of falling
• ability to provide written informed consent

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Exclusion Criteria

• inability to communicate because of language skills (e.g. aphasia, non-English speaking)
• inability to follow instructions due to dementia or severe cognitive impairment
• evidence of a condition that severely limits mobility (e.g Parkinson's disease, cerebrovascular accident)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timed Up and Go (TUG)	Upon enrolment, sub-group will repeat 2-3 days later.	Measure of balance and functional mobility in older adults. Includes a dual-task condition.
Incidence of Falls	baseline, 12 months	Falls during the previous year will be measured at baseline and then prospectively for 12 months using monthly fall diary calendars.
Brief-Balance Evaluation Systems Test (Brief-BESTest)	Upon enrolment, sub-group will repeat 2-3 days later.	Measure of balance. The Brief-BESTest is a shortened 6-item version of the 36-item full BESTest
Single-leg Stance Test (SLS)	Upon enrolment, sub-group will repeat 2-3 days later.	Measure of balance.

Secondary Outcome Measures

Name	Time	Method
Six-Minute Walk Test (6MWT)	Upon enrolment	Measure of exercise tolerance.
Fried's Frailty Phenotype	Upon enrolment	Measure of frailty including the following criteria: weight loss, exhaustion, physical activity, walk speed and grip strength in community-dwelling older adults.
Berg Balance Scale (BBS)	Upon enrolment	Measure of balance.
Activities-specific Balance Confidence Scale (ABC Scale)	Upon enrolment	Measure of balance confidence.
30-second Repeated Chair Stand Test	Upon enrolment	Measure of functional lower body strength.
Mini-Mental State Exam	Upon enrolment	Measure of five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.
Trail Making Test	Upon enrolment	Measure of cognitive executive function.
Self-reported function (PF-10)	Upon enrolment	Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey

Trial Locations

Locations (4)

Firestone Institute for Respiratory Health; 🇨🇦 Hamilton, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

North Hamilton Community Health Centre; 🇨🇦 Hamilton, Ontario, Canada

West Park Healthcare Centre; 🇨🇦 Toronto, Ontario, Canada