NCT02080442

Brief Summary

The study will involve direct knowledge translation of a laboratory-based study of balance training for patients with COPD, first to the investigators PR program and then, after disseminating the results, this approach could be used to impact on clinical practice in any PR program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

March 3, 2014

Last Update Submit

March 4, 2014

Conditions

Keywords

COPDBalancePulmonary Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale (BBS)

    The BBS was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.

    at 6 weeks

  • Timed Up and Go (TUG):

    The TUG was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.

    at 6 weeks

Secondary Outcomes (2)

  • The Balance Evaluation Systems Test (BESTest)

    at 6 weeks

  • Activity-specific Balance Confidence (ABC) Scale

    at 6 weeks

Other Outcomes (5)

  • Balance training progression: the training prescription and progression will be recorded

    at 6 weeks

  • Therapists' and the participants' satisfaction

    at 6 weeks

  • Safety: any adverse events associated with balance training will be recorded

    at 6 weeks

  • +2 more other outcomes

Study Arms (1)

Chronic Obstructive Pulmonary Disease

Other: Balance training

Interventions

Training will consist of 30 minute sessions 2-3 times/week for a total of 18-24 sessions, in keeping with best practice guidelines for older adults.12 Sessions will be supervised by physical therapists, using a circuit training approach with different stations designed to target specific areas of impairment. Participants will work through stations in a group setting; however, will receive individualized exercise prescription regarding level of difficulty and exercise progression.

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COPD enrolled in PR

You may qualify if:

  • Diagnosis of COPD
  • Self-report of decline in balance or fall in the last 5 years or a recent near fall
  • Smoking history greater than 10 pack years
  • Are able to provide written informed consent.

You may not qualify if:

  • An inability to communicate because of language skills, hearing or cognitive impairment
  • Evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced Parkinson's disease, amputation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Park Healthcare Center

Toronto, Ontario, M6M 2J5, Canada

Location

Related Publications (1)

  • Harrison SL, Beauchamp MK, Sibley K, Araujo T, Romano J, Goldstein RS, Brooks D. Minimizing the evidence-practice gap - a prospective cohort study incorporating balance training into pulmonary rehabilitation for individuals with chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Jul 23;15:73. doi: 10.1186/s12890-015-0067-2.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ms Samantha Harrison

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 6, 2014

Study Start

May 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations