Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Aerobic exercise training intensity

• Registration Number: NCT01944072
• Lead Sponsor: Universidade Nova de Lisboa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Study First Posted: 2013-09-17
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60%	Aerobic exercise training intensity	aerobic exercise training intensity of 60%Wmax
80%	Aerobic exercise training intensity	aerobic exercise training intensity of 80%Wmax

Primary Outcome Measures

Name	Time	Method
Health-related quality-of-life measured by the St.George's respiratory questionnaire	8 weeks (20 sessions)

Secondary Outcome Measures

Name	Time	Method
Symptoms control measured by the Mahler dyspnea index	8 weeks (20 sessions)
Exercise Tolerance	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