Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic exercise training intensity
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, COPD, Pulmonary rehabilitation, Aerobic exercise, CEDOC, FCM, UNL, NOVA MEDICAL SCHOOL
Eligibility Criteria
Inclusion Criteria:
- Clinically stable COPD
- FEV1/FVC < 70%
- Exercise training medical referral
Exclusion Criteria:
- Unable to attend 3-times/week program
- Infectious disease
- Metastatic cancer
- Unstable heart disease
- Neuromusculoskeletal disorder
- Cognitive or psychiatric disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
60%
80%
Arm Description
aerobic exercise training intensity of 60%Wmax
aerobic exercise training intensity of 80%Wmax
Outcomes
Primary Outcome Measures
Health-related quality-of-life measured by the St.George's respiratory questionnaire
Secondary Outcome Measures
Symptoms control measured by the Mahler dyspnea index
Exercise Tolerance
exercise tolerance assessed by the London-Chest activity of daily-living scale, 6-minute walk test, incremental exercise test and constant-load exercise test
Full Information
NCT ID
NCT01944072
First Posted
September 9, 2013
Last Updated
September 12, 2013
Sponsor
Universidade Nova de Lisboa
Collaborators
Centro Hospitalar Lisboa Norte, Centro de Estudos de Doenças Crónicas
1. Study Identification
Unique Protocol Identification Number
NCT01944072
Brief Title
Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes
Official Title
Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Nova de Lisboa
Collaborators
Centro Hospitalar Lisboa Norte, Centro de Estudos de Doenças Crónicas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group design studied the effect of two aerobic exercise-training intensities in COPD patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise training intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. Outcomes were assessed with St.George's respiratory questionnaire (primary outcome), Mahler dyspnea index, London Chest activity of daily living scale, 6-minute walk, constant load and incremental exercise tests. Patient's allocation sequence was computer-generated, with consignment in a safe deposit box.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Pulmonary rehabilitation, Aerobic exercise, CEDOC, FCM, UNL, NOVA MEDICAL SCHOOL
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
60%
Arm Type
Other
Arm Description
aerobic exercise training intensity of 60%Wmax
Arm Title
80%
Arm Type
Other
Arm Description
aerobic exercise training intensity of 80%Wmax
Intervention Type
Other
Intervention Name(s)
Aerobic exercise training intensity
Primary Outcome Measure Information:
Title
Health-related quality-of-life measured by the St.George's respiratory questionnaire
Time Frame
8 weeks (20 sessions)
Secondary Outcome Measure Information:
Title
Symptoms control measured by the Mahler dyspnea index
Time Frame
8 weeks (20 sessions)
Title
Exercise Tolerance
Description
exercise tolerance assessed by the London-Chest activity of daily-living scale, 6-minute walk test, incremental exercise test and constant-load exercise test
Time Frame
8 weeks (20 sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically stable COPD
FEV1/FVC < 70%
Exercise training medical referral
Exclusion Criteria:
Unable to attend 3-times/week program
Infectious disease
Metastatic cancer
Unstable heart disease
Neuromusculoskeletal disorder
Cognitive or psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catarina Santos, PT, MSc
Organizational Affiliation
Centro Hospitalar Lisboa Ocidental
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fátima Rodrigues, MD, MSc
Organizational Affiliation
Centro Hospitalar Lisboa Norte
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cristina Bárbara, MD, PhD
Organizational Affiliation
Centro Hospitalar Lisboa Norte
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26221044
Citation
Santos C, Rodrigues F, Santos J, Morais L, Barbara C. Pulmonary Rehabilitation in COPD: Effect of 2 Aerobic Exercise Intensities on Subject-Centered Outcomes--A Randomized Controlled Trial. Respir Care. 2015 Nov;60(11):1603-9. doi: 10.4187/respcare.03663. Epub 2015 Jul 28.
Results Reference
derived
Learn more about this trial
Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes
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