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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Aerobic Physical Training Associated With Noninvasive Ventilation on COPD Patient Functionality - A Controlled Randomized Study

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: physical training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Training Group<br>This group performed aerobic physical training in treadmill. | Other: physical training<br>* For both groups, the approximately hour-long sessions occurred three times a week on alternate days for six consecutive weeks (18 sessions). Each session began with five minutes of stretching that included the cervical muscles and the upper and lower limbs, which was followed by five minutes of warm-up on a treadmill at 2Km/h and 30 minutes of aerobic physical training at a constant 3% incline.<br>* Other names: PTGNIV: exercise plus bilevel ventilation group;|
| Experimental: NIV Trained<br>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. | Other: physical training<br>* For both groups, the approximately hour-long sessions occurred three times a week on alternate days for six consecutive weeks (18 sessions). Each session began with five minutes of stretching that included the cervical muscles and the upper and lower limbs, which was followed by five minutes of warm-up on a treadmill at 2Km/h and 30 minutes of aerobic physical training at a constant 3% incline.<br>* Other names: PTGNIV: exercise plus bilevel ventilation group;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxygen consumption. | 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. | 6 weeks | 
| Change in metabolic rate. | 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. | 6 weeks. | 
| Change in oxygenation. | 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. | 6 weeks. | 
| Change in sensation of dyspnea. | 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. | 6 weeks | 
| Change in quality of life. | It was evaluated through the SF-36 (domains: physical functioning, role-physical, and vitality). | 6 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerobic exercise, noninvasive ventilation, functionality