Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Balance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by West Park Healthcare Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ontario Lung Association
Information provided by (Responsible Party):
Roger Goldstein, West Park Healthcare Centre
ClinicalTrials.gov Identifier:
NCT01424098
First received: August 22, 2011
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Behavioral: Balance training program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Balance Training in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by West Park Healthcare Centre:

Primary Outcome Measures:
  • Berg Balance Scale [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Balance Evaluation Systems Test [ Time Frame: At baseline and 6 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Balance confidence/falls self-efficacy [ Time Frame: At baseline and 6 weeks. ] [ Designated as safety issue: No ]
  • Functional strength [ Time Frame: At baseline and 6 weeks. ] [ Designated as safety issue: No ]
  • Self-reported physical function [ Time Frame: At baseline and 6 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: August 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Balance Training
The treatment group will complete a specific balance training program in addition to conventional pulmonary rehabilitation.
Behavioral: Balance training program
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.
No Intervention: Usual care
The control group will undergo the usual pulmonary rehabilitation program offered at our centre with no additional balance training classes.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424098

Contacts
Contact: Marla K Beauchamp, MSc.PT 416-243-3600 ext 3665 marla.beauchamp@utoronto.ca

Locations
Canada, Ontario
West Park Healthcare Centre Recruiting
Toronto, Ontario, Canada, M6M2J5
Contact: Marla K Beauchamp, MSc.PT    416-243-3600 ext 3665    marla.beauchamp@utoronto.ca   
Sponsors and Collaborators
Roger Goldstein
Ontario Lung Association
Investigators
Principal Investigator: Dina Brooks, PhD University of Toronto
Principal Investigator: Roger S Goldstein, MD West Park Healthcare Centre
Study Chair: Marla K Beauchamp, MSc.PT University of Toronto
Study Chair: Tania Janaudis-Ferreira, PhD West Park Healthcare Centre
  More Information

No publications provided by West Park Healthcare Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roger Goldstein, Director, Respiratory Medicine, West Park Healthcare Centre
ClinicalTrials.gov Identifier: NCT01424098     History of Changes
Other Study ID Numbers: Goldstein_OTSBalanceRCT_2012
Study First Received: August 22, 2011
Last Updated: August 24, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014