Clinical trial NCT01464736: Noninvasive Ventilation on Chronic Obstructive Pulmonary Disease (COPD) Patient Functionality
Official title: Impact of Aerobic Physical Training Associated With Noninvasive Ventilation on COPD Patient Functionality - A Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: aerobic exercise
noninvasive ventilation
functionality
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 23
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of aerobic exercise, either associated or not with NIV, by two positive pressure levels on COPD patient functionality.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in oxygen consumption.
timeFrame: 6 weeks
measure: Change in metabolic rate.
timeFrame: 6 weeks.
measure: Change in oxygenation.
timeFrame: 6 weeks.
measure: Change in sensation of dyspnea.
timeFrame: 6 weeks
measure: Change in quality of life.
timeFrame: 6 weeks.
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Universidade Federal de São Carlos - UFSCar.
state: São Paulo
Study officials:
affiliation: Universidade Federal de São Carlos - UFSCar.
name: Kamilla T Marrara, Doutoranda
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de São Carlos - UFSCar.
name: Diego M Marino, Doutorando
role: STUDY_CHAIR
affiliation: Universidade Federal de São Carlos - UFSCar.
name: Maurício Jamami, Professor
role: STUDY_CHAIR
affiliation: Santa Casa de Misericórdia de São Carlos
name: Antônio D Oliveira Junior, Médico
role: STUDY_CHAIR
affiliation: Universidade Federal de São Carlos - UFSCar.
name: Valéria A Pires Di Lorenzo, Professora
role: STUDY_DIRECTOR
References:
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