Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?

NCT00864084 | Completed Phase 1 Results

• 1 other identifier: B2009:007
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• Balance Confidence

  Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks

• Fear of Falling

  Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks

• Confidence in Disease Management

  Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks

Study Arms (1)

Pulmonary rehabilitation

EXPERIMENTAL

People with respiratory disease

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation OTHER

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

Pulmonary rehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• The University of Queensland: collaborator

Study Sites (1)

The University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Related Publications (1)

• 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.

  PMID: 26814219 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Limitations and Caveats

This sample size in this study was small. Study participants received an individualised exercise program which means that exercises given and number of pulmonary rehabilitation sessions attended were not standardized between study participants.

Results Point of Contact

• Title: Ms Elizabeth Harvey
• Organization: The University of Manitoba

harveye@cc.umanitoba.ca

204-977-5656

Study Officials

• Michelle D Smith, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 5, 2014
• Results First Posted: August 20, 2014

Record last verified: 2014-08

Locations

CA (1)