Trial Outcomes & Findings for Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease? (NCT NCT00864084)

NCT ID: NCT00864084

Last Updated: 2014-09-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
• Results posted on: 2014-09-05

Participant Flow

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.

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.

Participant milestones

Measure	Pulmonary Rehabilitation An 8-week out-patient pulmonary rehabilitation program.
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?

Baseline characteristics by cohort

Measure	Pulmonary Rehabilitation n=14 Participants People with respiratory disease
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	69.6 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Canada	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Pre-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.	Post-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Post-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
Standing Balance - Sway Path Anteroposterior sway path	1.57 cm/s Standard Deviation 0.91	3.40 cm/s Standard Deviation 3.10	1.65 cm/s Standard Deviation 0.61	2.59 cm/s Standard Deviation 1.68
Standing Balance - Sway Path Mediolateral sway path (cm/s)	0.60 cm/s Standard Deviation 0.35	1.22 cm/s Standard Deviation 0.90	0.67 cm/s Standard Deviation 0.36	0.79 cm/s Standard Deviation 0.43

PRIMARY outcome

Timeframe: 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}.

Outcome measures

Measure	Pre-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Pre-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.	Post-pulmonary Rehabilitation - Eyes Open Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Post-pulmonary Rehabilitation - Eyes Closed Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
Dynamic Balance Timed Up and Go	10.7 seconds Standard Deviation 4.45	9.26 seconds Standard Deviation 3.36	—	—
Dynamic Balance Four Square Step Test	11.1 seconds Standard Deviation 5.03	9.23 seconds Standard Deviation 2.72	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Pre-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.	Post-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Post-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
Standing Balance - Critical Point in Time Anteroposterior critical point in time (s)	1.17 s Standard Deviation 0.48	0.87 s Standard Deviation 0.57	1.18 s Standard Deviation 0.71	0.81 s Standard Deviation 0.42
Standing Balance - Critical Point in Time Mediolateral critical point in time	1.26 s Standard Deviation 0.51	1.22 s Standard Deviation 0.76	1.08 s Standard Deviation 0.21	0.95 s Standard Deviation 0.45

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Pre-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.	Post-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Post-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
Standing Balance - Critical Point in Distance Anteroposterior critical point in distance (cm)	0.54 cm Standard Deviation 0.34	1.36 cm Standard Deviation 1.25	0.71 cm Standard Deviation 0.65	1.05 cm Standard Deviation 0.84
Standing Balance - Critical Point in Distance Mediolateral critical point in distance	0.19 cm Standard Deviation 0.28	0.55 cm Standard Deviation 0.67	0.21 cm Standard Deviation 0.21	0.17 cm Standard Deviation 0.18

SECONDARY outcome

Timeframe: 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}.

Outcome measures

Measure	Pre-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Pre-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.	Post-pulmonary Rehabilitation - Eyes Open Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Post-pulmonary Rehabilitation - Eyes Closed Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
Balance Confidence	75.3 units on a scale Standard Deviation 20.3	72.0 units on a scale Standard Deviation 21.4	—	—

SECONDARY outcome

Timeframe: 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}.

Outcome measures

Measure	Pre-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Pre-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.	Post-pulmonary Rehabilitation - Eyes Open Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Post-pulmonary Rehabilitation - Eyes Closed Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
Fear of Falling	1.78 scores on a scale Standard Deviation 0.63	1.83 scores on a scale Standard Deviation 0.59	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-pulmonary Rehabilitation - Eyes Open n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Pre-pulmonary Rehabilitation - Eyes Closed n=11 Participants Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.	Post-pulmonary Rehabilitation - Eyes Open Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.	Post-pulmonary Rehabilitation - Eyes Closed Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
Confidence in Disease Management	3.27 scores on a scale Standard Deviation 0.68	3.56 scores on a scale Standard Deviation 0.71	—	—

Adverse Events

Study Participation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ms Elizabeth Harvey

The University of Manitoba

Phone: 204-977-5656

Email: harveye@cc.umanitoba.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place