search
Back to results

Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?

Primary Purpose

Lung Diseases

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Manitoba

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary rehabilitation

Arm Description

People with respiratory disease

Outcomes

Primary Outcome Measures

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.
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}.
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.
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.

Secondary Outcome Measures

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}.
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}.
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.

Full Information

First Posted
March 17, 2009
Last Updated
August 26, 2014
Sponsor
University of Manitoba
Collaborators
The University of Queensland
search

1. Study Identification

Unique Protocol Identification Number
NCT00864084
Brief Title
Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?
Official Title
Does a Pulmonary Rehabilitation Program Improve Balance in Individuals With Respiratory Disease?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
The University of Queensland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
People with respiratory disease
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
Pulmonary rehabilitation involves the prescription of customized exercise programs and education on disease management.
Primary Outcome Measure Information:
Title
Standing Balance - Sway Path
Description
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.
Time Frame
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
Title
Dynamic Balance
Description
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}.
Time Frame
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
Title
Standing Balance - Critical Point in Time
Description
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.
Time Frame
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
Title
Standing Balance - Critical Point in Distance
Description
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.
Time Frame
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
Secondary Outcome Measure Information:
Title
Balance Confidence
Description
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}.
Time Frame
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
Title
Fear of Falling
Description
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}.
Time Frame
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
Title
Confidence in Disease Management
Description
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.
Time Frame
Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle D Smith, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26814219
Citation
Smith MD, Harvey EH, van den Hoorn W, Shay BL, Pereira GM, Hodges PW. Out-Patient Pulmonary Rehabilitation Improves Medial-Lateral Balance in Subjects With Chronic Respiratory Disease: Proof-of-Concept Study. Respir Care. 2016 Apr;61(4):510-20. doi: 10.4187/respcare.04109. Epub 2016 Jan 26.
Results Reference
derived

Learn more about this trial

Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?

We'll reach out to this number within 24 hrs