Fall Risk Assessment in COPD

Validity and Reliability of Balance Screening Tests for Fall Risk Assessment in COPD

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; COPD

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.

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
    • Hamilton, Ontario, Canada, L8N 4A6
      • Firestone Institute for Respiratory Health
    • Hamilton, Ontario, Canada, L8L 4N5
      • North Hamilton Community Health Centre
    • Toronto, Ontario, Canada, M6M 2J6
      • West Park Healthcare Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Individuals greater than 60 years of age diagnosed with COPD who have had one or more falls in the last year or who self-report problems with their balance or fear of falling.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: West Park Healthcare Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Balance; COPD; Screening; Falls
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 3331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No