NCT01424098

Brief Summary

A growing body of evidence suggests that individuals with chronic lung disease have important deficits in balance control that may be associated with an increased risk of falls. The main purpose of this study is to examine the effects of a balance training program on measures of balance and fall risk in people with chronic lung disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2011

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

August 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

August 22, 2011

Last Update Submit

April 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale

    All outcomes will be assessed upon admission to pulmonary rehabilitation (baseline) and again upon completion of the program, an expected average of 6 weeks from baseline.

  • Balance Evaluation Systems Test

    At baseline and 6 weeks.

Secondary Outcomes (3)

  • Balance confidence/falls self-efficacy

    At baseline and 6 weeks.

  • Functional strength

    At baseline and 6 weeks.

  • Self-reported physical function

    At baseline and 6 weeks.

Study Arms (2)

Balance Training

EXPERIMENTAL

The treatment group will complete a specific balance training program in addition to conventional pulmonary rehabilitation.

Behavioral: Balance training program

Usual care

NO INTERVENTION

The control group will undergo the usual pulmonary rehabilitation program offered at our centre with no additional balance training classes.

Interventions

Training will consist of 30 minute sessions 3 times/week for 6 weeks in keeping with best practice guidelines for older adults. 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.

Balance Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD; a 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; and are able to provide written informed consent.

You may not qualify if:

  • Inability to communicate because of language skills, hearing or cognitive impairment; and 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 Centre

Toronto, Ontario, M6M2J5, Canada

Location

Related Publications (1)

  • Beauchamp MK, Janaudis-Ferreira T, Parreira V, Romano JM, Woon L, Goldstein RS, Brooks D. A randomized controlled trial of balance training during pulmonary rehabilitation for individuals with COPD. Chest. 2013 Dec;144(6):1803-1810. doi: 10.1378/chest.13-1093.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dina Brooks, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR
  • Roger S Goldstein, MD

    West Park Healthcare Centre

    PRINCIPAL INVESTIGATOR
  • Marla K Beauchamp, MSc.PT

    University of Toronto

    STUDY CHAIR
  • Tania Janaudis-Ferreira, PhD

    West Park Healthcare Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Respiratory Medicine

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 26, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations