Noninvasive Ventilation on Chronic Obstructive Pulmonary Disease (COPD) Patient Functionality

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01464736
• Lead Sponsor: Universidade Federal de Sao Carlos

Brief Summary

On the following tests, there would be a greater increase in the functionality of COPD patients who underwent combined therapy than in those who only exercised: a set of activities of daily living (ADLs), the six-minute walk test (6MWT), an incremental symptom-limited cardiopulmonary test (CPT), and the physical functioning scale of the Short-Form 36 quality of life questionnaire (SF-36).

Detailed Description

Impact of aerobic exercise plus noninvasive ventilation (NIV) on the functionality of patients with COPD. Thirty patients (70.5 - 8.5 years) with COPD (forced expiratory volume in the first second 48.5 - 15.4% of predicted) were randomized into either a physical training group involving aerobic treadmill exercise (PTG, n=12) or an exercise plus bilevel ventilation group (PTGNIV, n=11) with sessions three times a week for six weeks.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2011-10
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-10-31
• Last Update Submitted: 2011-10-31
• Study First Posted: 2011-11-03
• Last Update Posted: 2011-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

• COPD diagnosis
• with a forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC)<70%
• clinical stability in the previous two months (i.e., no exacerbation of the disease).

Exclusion Criteria

• decompensated heart failure or rheumatic, orthopedic or neuromuscular diseases that prevented the subjects from performing the tests due to exercise limitations;
• participation in a regular physical exercise program at the beginning of the study;
• noncompletion of one of the tests or the established protocol for any reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of aerobic exercise, either associated or not with NIV, by two positive pressure levels on COPD patient functionality.	6 weeks	It was measured by means of step-climbing repetitions and distance covered in the six-minute walk test as well as the CPT.

Secondary Outcome Measures

Name	Time	Method
Change in oxygen consumption.	6 weeks	It was evaluated through a MedGraphics VO2000 metabolic system which was operated via computer with Aerograph software and store the signals with the 20-second method at the peak of each activity in the set of ADLs and in the peak of CPT.
Change in metabolic rate.	6 weeks.	It was evaluated through a MedGraphics VO2000 metabolic system which was operated via computer with Aerograph software and store the signals with the 20-second method at the peak of each activity in the set of ADLs and in the peak of CPT.
Change in oxygenation.	6 weeks.	It was evaluated through a Dixtal® wrist oxymeter at the peak of each activity in the set of ADLs and in the peak of CPT.
Change in sensation of dyspnea.	6 weeks	It was evaluated through a modified Borg scale at the peak of each activity in the set of ADLs and in the peak of CPT.
Change in quality of life.	6 weeks.	It was evaluated through the SF-36 (domains: physical functioning, role-physical, and vitality).

Trial Locations

Locations (1)

Universidade Federal de São Carlos - UFSCar.; 🇧🇷 São Carlos, São Paulo, Brazil