Fall Risk Assessment in COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229473
• Other study ID #: 3331
• Status: Completed
• Start date: September 14, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Pulmonary Disease

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Single-leg Stance Test (SLS)	Measure of balance.	Upon enrolment, sub-group will repeat 2-3 days later.
Primary	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	Berg Balance Scale (BBS)	Measure of balance.	Upon enrolment
Secondary	Activities-specific Balance Confidence Scale (ABC Scale)	Measure of balance confidence.	Upon enrolment
Secondary	30-second Repeated Chair Stand Test	Measure of functional lower body strength.	Upon enrolment
Secondary	Six-Minute Walk Test (6MWT)	Measure of exercise tolerance.	Upon enrolment
Secondary	Self-reported function (PF-10)	Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey	Upon enrolment
Secondary	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
Secondary	Mini-Mental State Exam	Measure of five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.	Upon enrolment
Secondary	Trail Making Test	Measure of cognitive executive function.	Upon enrolment