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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01464736
Acronym
kmarrara
Enrollment
23
Registered
2011-11-03
Start date
2006-01-31
Completion date
2010-12-31
Last updated
2011-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

aerobic exercise, noninvasive ventilation, functionality

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.

Interventions

OTHERphysical training

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.

Sponsors

Universidade Federal de Sao Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
60 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in oxygen consumption.6 weeksIt 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 weeksIt 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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026