Clinical trial NCT03229473: Fall Risk Assessment in COPD
Official title: Validity and Reliability of Balance Screening Tests for Fall Risk Assessment in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
COPD
Keywords: Balance
Falls
Screening
COPD
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: West Park Healthcare Centre
First posted: 2017-07-25
Enrollment: 94
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brief-Balance Evaluation Systems Test (Brief-BESTest)
timeFrame: Upon enrolment, sub-group will repeat 2-3 days later.
measure: Timed Up and Go (TUG)
timeFrame: Upon enrolment, sub-group will repeat 2-3 days later.
measure: Single-leg Stance Test (SLS)
timeFrame: Upon enrolment, sub-group will repeat 2-3 days later.
measure: Incidence of Falls
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Upon enrolment
measure: Activities-specific Balance Confidence Scale (ABC Scale)
timeFrame: Upon enrolment
measure: 30-second Repeated Chair Stand Test
timeFrame: Upon enrolment
measure: Six-Minute Walk Test (6MWT)
timeFrame: Upon enrolment
measure: Self-reported function (PF-10)
timeFrame: Upon enrolment
measure: Fried's Frailty Phenotype
timeFrame: Upon enrolment
measure: Mini-Mental State Exam
timeFrame: Upon enrolment
measure: Trail Making Test
timeFrame: Upon enrolment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: North Hamilton Community Health Centre
state: Ontario
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health
state: Ontario
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Marla Beauchamp, PhD
role: PRINCIPAL_INVESTIGATOR
References: