Impact of Feedback on Physical Activity and Health-related Outcomes During Pulmonary Rehabilitation in COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary rehabilitation (PR) plus PA-focused intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic obstructive pulmonary disease, COPD, Pulmonary rehabilitation, Physical activity, Exercise
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
- ≥ 18 years old
- clinical stability for 1 month prior to the study (no hospital admissions or exacerbations)
Exclusion Criteria:
- presence of severe psychiatric, neurologic or musculoskeletal conditions and/or unstable cardiovascular disease
- participation in regular exercise prior to the study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Activity group
Arm Description
Pulmonary rehabilitation plus physical activity intervention
Outcomes
Primary Outcome Measures
Change in physical activity levels
Physical activity data will be collected using a triaxial accelerometer. Number of steps per day and time spent in sedentary, light and moderate-to-vigorous intensity activities will be assessed. Time spent in different postures (i.e., standing, sitting and lying) will also be determined.
Secondary Outcome Measures
Change in exercise capacity
Exercise tolerance will be assessed with the 6-minute walk test, following the American Thoracic Society guidelines. The maximal distance walked during 6 minutes and the associated respiratory symptoms will be collected.
Change in peripheral muscle strength
Isometric muscle strength of the upper and lower limbs will be assessed with the 10-RM following the American College of Sports Medicine guidelines.
Change in activities limitation resulting from breathlessness
The Modified British Medical Research Council questionnaire comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
Change in functional balance
The Timed Up and Go (TUG) test is a functional balance test in which the time needed to perform the test is recorded.
Change in health-related quality of life
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure quality of life in patients with chronic lung disease. It has 3 domains: symptoms, activities and impact. Higher scores indicate poorer quality of life.
Patients' perspectives about the intervention
Semi-structured focus group interviews will be conducted with patients to explore their perspectives about the use of activity monitors and the feedback given.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02725931
Brief Title
Impact of Feedback on Physical Activity and Health-related Outcomes During Pulmonary Rehabilitation in COPD
Official Title
Impact of Feedback on Physical Activity Levels and Health-related Outcomes of Patients With COPD During Pulmonary Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate whether providing feedback on physical activity (PA) levels to patients with Chronic Obstructive Pulmonary Disease (COPD) is feasible and enhances daily PA and health-related outcomes during pulmonary rehabilitation (PR).
Patients will participate in a 12-week PR program and a PA-focused intervention. Patients' daily PA will be monitored during the first (W1), seventh (W7) and 12th (W12) weeks of the PR program using the activity monitors GT3X+ (ActiGraph, Pensacola, FL) and feedback will be given to them in the following weeks. Each participant will also receive individualised recommendations to improve or maintain their PA levels, based on the results of the previous week.
It is expected that, by receiving individualised feedback and goals regarding their PA levels during the PR program, patients with COPD will become more active and improve their health-related outcomes.
Detailed Description
Patients with Chronic Obstructive Pulmonary Disease (COPD) present lower levels of physical activity (PA), which have been associated with adverse outcomes including increased healthcare utilisation and reduced survival. Thus, improving PA levels has become one of the main goals of COPD research.
Pulmonary rehabilitation (PR) is a cornerstone of COPD management with well-documented effects on exercise capacity and quality of life. However, its effects in increasing patients' physical activity (PA) levels are limited. Previous research has suggested that PR with PA monitoring and feedback may be a suitable approach to increase and/or maintain patients' PA levels.
Patients with COPD will participate in a 12-week PR program plus a PA-focused intervention. Daily PA will be measured using activity monitors GT3X+ (ActiGraph, Pensacola, FL) on weeks (W) 1, 7 and 12 and feedback will be given to participants in the following weeks regarding: daily steps; time spent in sedentary, light and moderate-to-vigorous (MVPA) intensity activities.
The impact of the intervention will be explored using a mixed-methods approach.
Assessments will be conducted immediately before (W1) and after (W12) the PR program. Breathlessness, exercise capacity, functional balance, peripheral muscle strength and health-related quality of life will be assessed in both time points.
Descriptive statistics will be used to characterise the sample. To analyse changes in outcome measures, data from the two time points will be compared. Correlations between PA data and health-related outcomes will be performed at W1 and using the change scores (i.e., W12-W1).
Patients will also be invited to attend focus groups after the intervention to assess their perspectives about the use of activity monitors and the feedback given.
This is a pilot study which will inform the main study (including the sample size calculation).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Chronic obstructive pulmonary disease, COPD, Pulmonary rehabilitation, Physical activity, Exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activity group
Arm Type
Experimental
Arm Description
Pulmonary rehabilitation plus physical activity intervention
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary rehabilitation (PR) plus PA-focused intervention
Intervention Description
Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychosocial support and education sessions (once a week). Patients will also have their PA levels monitored on weeks (W) 1, 7 and 12 and receive feedback in the following weeks.
Primary Outcome Measure Information:
Title
Change in physical activity levels
Description
Physical activity data will be collected using a triaxial accelerometer. Number of steps per day and time spent in sedentary, light and moderate-to-vigorous intensity activities will be assessed. Time spent in different postures (i.e., standing, sitting and lying) will also be determined.
Time Frame
weeks 1, 7 and 12
Secondary Outcome Measure Information:
Title
Change in exercise capacity
Description
Exercise tolerance will be assessed with the 6-minute walk test, following the American Thoracic Society guidelines. The maximal distance walked during 6 minutes and the associated respiratory symptoms will be collected.
Time Frame
immediately before (week 1) and after (week 12) the PR program
Title
Change in peripheral muscle strength
Description
Isometric muscle strength of the upper and lower limbs will be assessed with the 10-RM following the American College of Sports Medicine guidelines.
Time Frame
immediately before (week 1) and after (week 12) the PR program
Title
Change in activities limitation resulting from breathlessness
Description
The Modified British Medical Research Council questionnaire comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
Time Frame
immediately before (week 1) and after (week 12) the PR program
Title
Change in functional balance
Description
The Timed Up and Go (TUG) test is a functional balance test in which the time needed to perform the test is recorded.
Time Frame
immediately before (week 1) and after (week 12) the PR program
Title
Change in health-related quality of life
Description
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure quality of life in patients with chronic lung disease. It has 3 domains: symptoms, activities and impact. Higher scores indicate poorer quality of life.
Time Frame
immediately before (week 1) and after (week 12) the PR program
Title
Patients' perspectives about the intervention
Description
Semi-structured focus group interviews will be conducted with patients to explore their perspectives about the use of activity monitors and the feedback given.
Time Frame
Immediately after the PR program (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
≥ 18 years old
clinical stability for 1 month prior to the study (no hospital admissions or exacerbations)
Exclusion Criteria:
presence of severe psychiatric, neurologic or musculoskeletal conditions and/or unstable cardiovascular disease
participation in regular exercise prior to the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alda S. Marques, PhD
Organizational Affiliation
Aveiro University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25278009
Citation
Cruz J, Brooks D, Marques A. Impact of feedback on physical activity levels of individuals with chronic obstructive pulmonary disease during pulmonary rehabilitation: A feasibility study. Chron Respir Dis. 2014 Nov;11(4):191-8. doi: 10.1177/1479972314552280. Epub 2014 Oct 2.
Results Reference
result
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Impact of Feedback on Physical Activity and Health-related Outcomes During Pulmonary Rehabilitation in COPD
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