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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944072
• Other study ID #: NOVA-FCM-MSAR-001
• Status: Completed
• Phase: N/A
• First received: September 9, 2013
• Last updated: September 12, 2013
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: September 2013
• Source: Universidade Nova de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Aerobic exercise training intensity

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Centro de Estudos de Doenças Crónicas, Centro Hospitalar Lisboa Norte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality-of-life measured by the St.George's respiratory questionnaire		8 weeks (20 sessions)	No
Secondary	Symptoms control measured by the Mahler dyspnea index		8 weeks (20 sessions)	No
Secondary	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	8 weeks (20 sessions)	No