Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00864084

Enrollment

Registered

2009-03-18

Start date

2009-04-30

Completion date

2009-12-31

Last updated

2014-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

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.

Interventions

OTHERPulmonary rehabilitation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
Standing Balance - Sway Path	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	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	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	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	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	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	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	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

Measure	Time frame	Description
Fear of Falling	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	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	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	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.
Balance Confidence	Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks	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}.

Countries

Canada

Participant flow

Recruitment details

Eleven individuals with stable chronic respiratory disease who were attendees of an institutional outpatient pulmonary rehabilitation program participated in this study. Recruitment occurred in April 2009 and at the pulmonary rehabilitation program.

Pre-assignment details

People enrolled in the pulmonary rehabilitation programs who had a clinical diagnosis of respiratory disease were included in the study. Exclusion criteria were: unstable cardiac disease, neurological conditions, or musculoskeletal conditions that prevented participation in pulmonary rehabilitation or testing sessions.

Participants by arm

Arm	Count
Pulmonary Rehabilitation People with respiratory disease	14
Total	14

Baseline characteristics

Characteristic	Pulmonary Rehabilitation
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	10 Participants
Age, Categorical Between 18 and 65 years	4 Participants
Age, Continuous	69.6 years STANDARD_DEVIATION 8.3
Region of Enrollment Canada	14 participants
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 11
serious Total, serious adverse events	0 / 11

Outcome results

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}.