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Fall Risk Assessment in COPD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03229473
Enrollment
94
Registered
2017-07-25
Start date
2017-09-14
Completion date
2021-03-31
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Pulmonary Disease

Keywords

Balance, Falls, Screening, COPD

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.

Interventions

None listed

Sponsors

West Park Healthcare Centre
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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
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.
Single-leg Stance Test (SLS)Upon enrolment, sub-group will repeat 2-3 days later.Measure of balance.
Incidence of Fallsbaseline, 12 monthsFalls during the previous year will be measured at baseline and then prospectively for 12 months using monthly fall diary calendars.

Secondary

MeasureTime frameDescription
Self-reported function (PF-10)Upon enrolmentPhysical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey
Fried's Frailty PhenotypeUpon enrolmentMeasure 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 enrolmentMeasure of balance.
Trail Making TestUpon enrolmentMeasure of cognitive executive function.
Mini-Mental State ExamUpon enrolmentMeasure of five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.
Activities-specific Balance Confidence Scale (ABC Scale)Upon enrolmentMeasure of balance confidence.
30-second Repeated Chair Stand TestUpon enrolmentMeasure of functional lower body strength.
Six-Minute Walk Test (6MWT)Upon enrolmentMeasure of exercise tolerance.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026