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: Aerobic exercise training intensity
Other: 80%
aerobic exercise training intensity of 80%Wmax
Other: Aerobic exercise training intensity

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

Universidade Nova de Lisboa

Collaborators

Centro Hospitalar Lisboa Norte
Centro de Estudos de Doenças Crónicas

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.

General Publications

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.

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