Pulmonary DiseaseNCT03229473
Fall Risk Assessment in COPD
An observational study of Pulmonary Disease and COPD, run by McMaster University at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pulmonary Disease, COPD
- How many people
- 94 participants
- Where
- 4 sitesCanada
- Study dates
- 14 Sep 2017to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
North Hamilton Community Health Centre
Hamilton, Ontario, L8L 4N5
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N 4A6
West Park Healthcare Centre
Toronto, Ontario, M6M 2J6
About this study
Official title: Validity and Reliability of Balance Screening Tests for Fall Risk Assessment in COPD
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.
Read the 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.
- Conditions
- Pulmonary Disease, COPD
- Keywords
- Balance, Falls, Screening, COPD
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Upon enrolment, sub-group will repeat 2-3 days later.
Timed Up and Go (TUG)
Measure of balance and functional mobility in older adults. Includes a dual-task condition.
Measured: Upon enrolment, sub-group will repeat 2-3 days later.
Single-leg Stance Test (SLS)
Measure of balance.
Measured: Upon enrolment, sub-group will repeat 2-3 days later.
Incidence of Falls
Falls during the previous year will be measured at baseline and then prospectively for 12 months using monthly fall diary calendars.
Measured: baseline, 12 months
Secondary outcomes (8)
Berg Balance Scale (BBS)
Measure of balance.
Measured: Upon enrolment
Activities-specific Balance Confidence Scale (ABC Scale)
Measure of balance confidence.
Measured: Upon enrolment
30-second Repeated Chair Stand Test
Measure of functional lower body strength.
Measured: Upon enrolment
Six-Minute Walk Test (6MWT)
Measure of exercise tolerance.
Measured: Upon enrolment
Self-reported function (PF-10)
Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey
Measured: Upon enrolment
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.
Measured: Upon enrolment
Mini-Mental State Exam
Measure of five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.
Measured: Upon enrolment
Trail Making Test
Measure of cognitive executive function.
Measured: Upon enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start14 Sep 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- West Park Healthcare Centre
- Responsible party
- Sponsor
- Investigators
- Marla Beauchamp, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229473
- Sponsor's protocol ID
- 3331
- Status last verified
- Apr 2023
- First submitted
- 21 Jul 2017
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nguyen KT, Ellerton C, Wald J, Raghavan N, Macedo LG, Brooks D, Goldstein R, Beauchamp MK. Validation of a clinical prediction model for falls in community-dwelling older adults with COPD: A preliminary analysis. Chron Respir Dis. 2025 Jan-Dec;22:14799731251321494. doi: 10.1177/14799731251321494.
PubMed 39957244
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Balance Screening Tests for Fall Risk Assessment in COPD
- ClinicalTrials.gov ID
- NCT03229473
- Acronym / sponsor ID
- 3331
- Conditions
- Pulmonary Disease, COPD
- Keywords
- Balance, Falls, Screening, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- West Park Healthcare Centre
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brief-Balance Evaluation Systems Test (Brief-BESTest)
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
Timed Up and Go (TUG)
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.
Single-leg Stance Test (SLS)
Time frame: Upon enrolment, sub-group will repeat 2-3 days later.
Measure of balance.
Incidence of Falls
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.
8 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Upon enrolment
Activities-specific Balance Confidence Scale (ABC Scale)
Time frame: Upon enrolment
30-second Repeated Chair Stand Test
Time frame: Upon enrolment
Six-Minute Walk Test (6MWT)
Time frame: Upon enrolment
Self-reported function (PF-10)
Time frame: Upon enrolment
Fried's Frailty Phenotype
Time frame: Upon enrolment
Mini-Mental State Exam
Time frame: Upon enrolment
Trail Making Test
Time frame: Upon enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Derived from this study: PubMed 39957244Nguyen KT, Ellerton C, Wald J, Raghavan N, Macedo LG, Brooks D, Goldstein R, Beauchamp MK. Validation of a clinical prediction model for falls in community-dwelling older adults with COPD: A preliminary analysis. Chron Respir Dis. 2025 Jan-Dec;22:14799731251321494. doi: 10.1177/14799731251321494.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marla Beauchamp, PhD principal investigator
McMaster University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and COPD, run by McMaster University at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief-Balance Evaluation Systems Test (Brief-BESTest) (time frame: Upon enrolment, sub-group will repeat 2-3 days later.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.