Fall Risk Assessment in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-14

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Proprioceptive Postural Control and Chronic Obstructive Pulmonary Disease (COPD)

NCT01505543

Proprioceptive Postural Control Chronic Obstructive Pulmonary Disease

COMPLETED

Clinical Evaluation of a Wireless Monitoring Device to Reduce Falls in the Elderly and Others at High Risk of Falling

NCT00249743

Accidental Falls Fractures Injuries

COMPLETED PHASE1/PHASE2

Determination of Factors Effecting Falls in Patients With COPD

NCT06483776

Pulmonary Disease, Chronic Obstructive Fall Balance; Distorted

NOT_YET_RECRUITING

Balance, Walking Speed, Quadriceps Femoris Muscle Strength and Quality of Life in Falling and Non-falling Individuals With COPD

NCT06099002

Copd

COMPLETED

Development of a Fall Prevention and Fall Detection System for Ambulatory Rehabilitation of Parkinson's Patients

NCT01262950

Parkinson's Disease

TEMPORARILY_NOT_AVAILABLE

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No