Fall Risk Assessment in COPD

Overview

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.

Full Title of Study: “Validity and Reliability of Balance Screening Tests for Fall Risk Assessment in COPD”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2021

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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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 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)

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McMaster University
  • Collaborator
    • West Park Healthcare Centre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marla Beauchamp, PhD, Principal Investigator, McMaster University
  • Overall Contact(s)
    • Marla Beauchamp, PhD, 416-574-7065, beaucm1@mcmaster.ca

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