Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?

This study has been completed.
Sponsor:
Collaborator:
The University of Queensland
Information provided by (Responsible Party):
Ms. Elizabeth Harvey, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00864084
First received: March 17, 2009
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether participation in pulmonary rehabilitation improves balance in people with respiratory disease.


Condition Intervention Phase
Lung Diseases
Other: Pulmonary rehabilitation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does a Pulmonary Rehabilitation Program Improve Balance in Individuals With Respiratory Disease?

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Standing Balance - Sway Path [ Time Frame: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks ] [ Designated as safety issue: No ]
    Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.

  • Dynamic Balance [ Time Frame: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks ] [ Designated as safety issue: No ]
    Dynamic balance was measured using the timed up and go (TUG) and Four Square Step Test (FSST). For the TUG, the time taken for the subject to stand from a chair, walk 3 m, turn around and return to the chair was recorded {Podsiadlo, 1991 #31}. Subjects were asked to do this as quickly and safely as possible. High test-retest reliability of the TUG has been reported in older community-dwelling individuals {Steffen, 2002 #34}. In the FSST, subjects were asked to step to four corners of a square in a clockwise and then counter-clockwise direction as quickly as possible {Dite, 2002 #1181}. The time taken to complete this circuit was recorded. This test has been shown to have high inter-rater and test-retest reliability {Dite, 2002 #1181}.

  • Standing Balance - Critical Point in Time [ Time Frame: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks ] [ Designated as safety issue: No ]
    Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.

  • Standing Balance - Critical Point in Distance [ Time Frame: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks ] [ Designated as safety issue: No ]
    Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.


Secondary Outcome Measures:
  • Balance Confidence [ Time Frame: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks ] [ Designated as safety issue: No ]
    Activity-Specific Balance Confidence (ABC) scale measures balance confidence during sixteen activities of progressive difficulty, such as going up and down stairs, reaching for objects and walking in crowded areas {Powell, 1995 #5}. It asks subjects to rate their level of confidence in performing an activity without losing balance on an 11-point scale ranging from 0% (no confidence) to 100% (completely confident). The score is calculated as the average score for each item. This questionnaire has been shown to be sensitive to detect changes in function following rehabilitation {Myers, 1998 #6} and has proven internal consistency and test-retest reliability {Powell, 1995 #5}.

  • Fear of Falling [ Time Frame: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks ] [ Designated as safety issue: No ]
    The Falls Efficacy Scale International (FESI) assesses fear of falling during a range of physical and social activities {Yardley, 2005 #1}. It asks about an individual's concern about the possibility of following during participation in sixteen common activities, such as cleaning the house, ascending and descending stairs and walking in various environmental conditions. Answers range from 1, "not at all" concerned, to 4, "very" concerned, on a 4-point scale, and score is calculated as the average response. This questionnaire has been shown to have excellent internal and test-retest reliability {Yardley, 2005 #1}.

  • Confidence in Disease Management [ Time Frame: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks ] [ Designated as safety issue: No ]
    The COPD Self-Efficacy Scale evaluates level of confidence in ability to manage or avoid breathing difficulty during a range of situations such as feeling frustrated and lifting heavy objects {Wigal, 1991 #3}. Possible answers range from "very confident" (5 points) to "not at all confident" (1 point) and the average score per question is calculated. This scale has been shown to have excellent internal consistency and good test-retest reliability.


Enrollment: 14
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulmonary rehabilitation
People with respiratory disease
Other: Pulmonary rehabilitation
Pulmonary rehabilitation involves the prescription of customized exercise programs and education on disease management.

Detailed Description:

Falls and chronic respiratory are two major health concerns affecting morbidity and mortality in older adults. Several factors that predispose falls, such as reduced balance, have been documented in people with respiratory disease. Pulmonary rehabilitation programs, which involve customized exercise prescription, are recommended to improve quality of life and disease management in people with chronic obstructive pulmonary disease (COPD). There are many documented benefits to participation in such programs; however, the impact on balance and other falls risk factors has not previously been investigated. Therefore, the aim of this study is to investigate the effect of a pulmonary rehabilitation program on balance and falls risk factors in individuals with respiratory disease. This study will enhance the current management of respiratory disease by improving our understanding of the effects of pulmonary rehabilitation.

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of lung disease
  • Committed to regular attendance at pulmonary rehabilitation program
  • A forced expiratory volume in 1 second (FEV1) < 80% of predicted
  • No change in medications for the past 2 months

Exclusion Criteria:

  • Unstable cardiac disease
  • Neurological conditions
  • Musculoskeletal conditions that prevent participation in exercise sessions.
  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: NCT00864084

Locations
Canada, Manitoba
The University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0T6
Sponsors and Collaborators
University of Manitoba
The University of Queensland
Investigators
Principal Investigator: Michelle D Smith, PhD The University of Queensland
  More Information

No publications provided

Responsible Party: Ms. Elizabeth Harvey, Ms, University of Manitoba
ClinicalTrials.gov Identifier: NCT00864084     History of Changes
Other Study ID Numbers: B2009:007
Study First Received: March 17, 2009
Results First Received: September 30, 2013
Last Updated: August 26, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014