Noninvasive Ventilation on Chronic Obstructive Pulmonary Disease (COPD) Patient Functionality
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Other: physical training
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 23
- 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).
- 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
- Arm && Interventions
Group Intervention Description Physical Training Group physical training This group performed aerobic physical training in treadmill. NIV Trained physical training This group performed aerobic physical training associated with ventilation in the bilevel modality (BiPAP®), using a nasal mask as an interface. On evaluation day, the levels of inspiratory positive airway pressure (IPAP) (between 10 and 15cmH2O) and expiratory positive airway pressure (EPAP) (between 4 and 6cmH2O) were defined, varying according to the comfort level of each patient.
- 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