Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes
1 other identifier
interventional
34
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease
Started Sep 2009
Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 9, 2013
CompletedFirst Posted
Study publicly available on registry
September 17, 2013
CompletedSeptember 17, 2013
September 1, 2013
6 months
September 9, 2013
September 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-related quality-of-life measured by the St.George's respiratory questionnaire
8 weeks (20 sessions)
Secondary Outcomes (2)
Symptoms control measured by the Mahler dyspnea index
8 weeks (20 sessions)
Exercise Tolerance
8 weeks (20 sessions)
Study Arms (2)
60%
OTHERaerobic exercise training intensity of 60%Wmax
80%
OTHERaerobic exercise training intensity of 80%Wmax
Interventions
Eligibility Criteria
You may qualify if:
- Clinically stable COPD
- FEV1/FVC \< 70%
- Exercise training medical referral
You may not qualify if:
- Unable to attend 3-times/week program
- Infectious disease
- Metastatic cancer
- Unstable heart disease
- Neuromusculoskeletal disorder
- Cognitive or psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Nova de Lisboalead
- Centro Hospitalar Lisboa Nortecollaborator
- Centro de Estudos de Doenças Crónicascollaborator
Related Publications (1)
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.
PMID: 26221044DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2013
First Posted
September 17, 2013
Study Start
September 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
September 17, 2013
Record last verified: 2013-09