RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection
NCT06149494
COPD, COPD Exacerbation Acute
London, United Kingdom
View Trial DetailsNCT Number: NCT03229473
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.
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Notify Me60 year and older
All sexes
Observational
Firestone Institute for Respiratory Health, Hamilton, Ontario, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: Upon enrolment, sub-group will repeat 2-3 days later.
Measure of balance.
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.
Time frame: Upon enrolment
Measure of balance.
Time frame: Upon enrolment
Measure of balance confidence.
Time frame: Upon enrolment
Measure of functional lower body strength.
Time frame: Upon enrolment
Measure of exercise tolerance.
Time frame: Upon enrolment
Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey
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.
Time frame: Upon enrolment
Measure of five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.
Time frame: Upon enrolment
Measure of cognitive executive function.
McMaster University
Other
Validity and Reliability of Balance Screening Tests for Fall Risk Assessment in COPD
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