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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
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 22, 2016
    Last Updated
    March 29, 2016
    Sponsor
    Aveiro University
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    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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