Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?

Lung Diseases Clinical Trial

Official title:

Does a Pulmonary Rehabilitation Program Improve Balance in Individuals With Respiratory Disease?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864084
• Other study ID #: B2009:007
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2009
• Last updated: August 26, 2014
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2014
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Diseases
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Pulmonary rehabilitation
Pulmonary rehabilitation involves the prescription of customized exercise programs and education on disease management.

Locations

Country	Name	City	State
Canada	The University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	The University of Queensland

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standing Balance - Sway Path	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.	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	No
Primary	Dynamic Balance	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}.	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	No
Primary	Standing Balance - Critical Point in Time	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.	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	No
Primary	Standing Balance - Critical Point in Distance	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.	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	No
Secondary	Balance Confidence	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}.	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	No
Secondary	Fear of Falling	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}.	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	No
Secondary	Confidence in Disease Management	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.	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	No