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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
Universidade Nova de Lisboa
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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

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

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