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

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ClinicalTrials.gov Identifier: NCT01944072
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
Sponsor:
Collaborators:
Centro Hospitalar Lisboa Norte
Centro de Estudos de Doenças Crónicas
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Aerobic exercise training intensity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes - a Randomized Controlled Trial
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
60%
aerobic exercise training intensity of 60%Wmax
Other: Aerobic exercise training intensity
80%
aerobic exercise training intensity of 80%Wmax
Other: Aerobic exercise training intensity



Primary Outcome Measures :
  1. Health-related quality-of-life measured by the St.George's respiratory questionnaire [ Time Frame: 8 weeks (20 sessions) ]

Secondary Outcome Measures :
  1. Symptoms control measured by the Mahler dyspnea index [ Time Frame: 8 weeks (20 sessions) ]
  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944072


Sponsors and Collaborators
Universidade Nova de Lisboa
Centro Hospitalar Lisboa Norte
Centro de Estudos de Doenças Crónicas
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidade Nova de Lisboa
ClinicalTrials.gov Identifier: NCT01944072     History of Changes
Other Study ID Numbers: NOVA-FCM-MSAR-001
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

Keywords provided by Universidade Nova de Lisboa:
Chronic Obstructive Pulmonary Disease
COPD
Pulmonary rehabilitation
Aerobic exercise
CEDOC
FCM
UNL
NOVA MEDICAL SCHOOL

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases