NCT03229473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 14, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

3.5 years

First QC Date

July 21, 2017

Last Update Submit

April 21, 2023

Conditions

Pulmonary DiseaseCOPD

Keywords

BalanceFallsScreeningCOPD

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • Single-leg Stance Test (SLS)

    Measure of balance.

    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.

    baseline, 12 months

Secondary Outcomes (8)

  • Berg Balance Scale (BBS)

    Upon enrolment

  • Activities-specific Balance Confidence Scale (ABC Scale)

    Upon enrolment

  • 30-second Repeated Chair Stand Test

    Upon enrolment

  • Six-Minute Walk Test (6MWT)

    Upon enrolment

  • Self-reported function (PF-10)

    Upon enrolment

  • +3 more secondary outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

North Hamilton Community Health Centre

Hamilton, Ontario, L8L 4N5, Canada

Location

Firestone Institute for Respiratory Health

Hamilton, Ontario, L8N 4A6, Canada

Location

West Park Healthcare Centre

Toronto, Ontario, M6M 2J6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 39957244DERIVED

MeSH Terms

Conditions

Lung DiseasesPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marla Beauchamp, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 25, 2017

Study Start

September 14, 2017

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations

CA(4)