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| Name | Class |
|---|---|
| The University of Queensland | OTHER |
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The purpose of this study is to determine whether participation in pulmonary rehabilitation improves balance in people with respiratory disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary rehabilitation | Experimental | People with respiratory disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary rehabilitation | Other | Pulmonary rehabilitation involves the prescription of customized exercise programs and education on disease management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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}. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle D Smith, PhD | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manitoba | Winnipeg | Manitoba | R3E 0T6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26814219 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Rehabilitation | An 8-week out-patient pulmonary rehabilitation program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Rehabilitation | People with respiratory disease |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | cm/s | Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participation | Participant data collection at baseline (pre-pulmonary rehabilitation), participation in an 8-week outpatient pulmonary rehabilitation program and data collection at follow-up (post-pulmonary rehabilitation). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms Elizabeth Harvey | The University of Manitoba | 204-977-5656 | harveye@cc.umanitoba.ca |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
| Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
| 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 |
| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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}. | Posted | Mean | Standard Deviation | seconds | Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
|
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| 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}. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
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| 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}. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
|
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | s | Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
|
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| 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. | Posted | Mean | Standard Deviation | cm | Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks |
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| 0 |
| 11 |
| 0 |
| 11 |
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| Mediolateral critical point in time |
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| Mediolateral critical point in distance |
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