Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes
September 12, 2013 updated by: Universidade Nova de Lisboa
Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes - a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 60%
aerobic exercise training intensity of 60%Wmax
|
|
|
Other: 80%
aerobic exercise training intensity of 80%Wmax
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Health-related quality-of-life measured by the St.George's respiratory questionnaire
Time Frame: 8 weeks (20 sessions)
|
8 weeks (20 sessions)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptoms control measured by the Mahler dyspnea index
Time Frame: 8 weeks (20 sessions)
|
8 weeks (20 sessions)
|
|
|
Exercise Tolerance
Time Frame: 8 weeks (20 sessions)
|
exercise tolerance assessed by the London-Chest activity of daily-living scale, 6-minute walk test, incremental exercise test and constant-load exercise test
|
8 weeks (20 sessions)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catarina Santos, PT, MSc, Centro Hospitalar Lisboa Ocidental
- Study Chair: Fátima Rodrigues, MD, MSc, Centro Hospitalar Lisboa Norte
- Study Director: Cristina Bárbara, MD, PhD, Centro Hospitalar Lisboa Norte
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
September 9, 2013
First Submitted That Met QC Criteria
September 12, 2013
First Posted (Estimate)
September 17, 2013
Study Record Updates
Last Update Posted (Estimate)
September 17, 2013
Last Update Submitted That Met QC Criteria
September 12, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOVA-FCM-MSAR-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.