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

NCT ID: NCT01944072

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Chronic Obstructive Pulmonary Disease COPD Pulmonary rehabilitation Aerobic exercise CEDOC FCM UNL NOVA MEDICAL SCHOOL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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60%

aerobic exercise training intensity of 60%Wmax

Group Type OTHER

Aerobic exercise training intensity

Intervention Type OTHER

80%

aerobic exercise training intensity of 80%Wmax

Group Type OTHER

Aerobic exercise training intensity

Intervention Type OTHER

Interventions

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Aerobic exercise training intensity

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Hospitalar Lisboa Norte

OTHER

Sponsor Role collaborator

Centro de Estudos de Doenças Crónicas

OTHER

Sponsor Role collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catarina Santos, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Lisboa Ocidental

Fátima Rodrigues, MD, MSc

Role: STUDY_CHAIR

Centro Hospitalar Lisboa Norte

Cristina Bárbara, MD, PhD

Role: STUDY_DIRECTOR

Centro Hospitalar Lisboa Norte

References

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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.

Reference Type DERIVED
PMID: 26221044 (View on PubMed)

Other Identifiers

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NOVA-FCM-MSAR-001

Identifier Type: -

Identifier Source: org_study_id