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Clinical Trials/NCT01464736
NCT01464736
Completed
Not Applicable

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

Universidade Federal de Sao Carlos1 site in 1 country23 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Universidade Federal de Sao Carlos
Enrollment
23
Locations
1
Primary Endpoint
Impact of aerobic exercise, either associated or not with NIV, by two positive pressure levels on COPD patient functionality.
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
December 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Universidade Federal de Sao Carlos
Responsible Party
Principal Investigator
Principal Investigator

Kamilla Tays Marrara

Doutoranda em Fisioterapia pela Universidade Federal de São Carlos - UFSCar.

Universidade Federal de Sao Carlos

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.

Outcomes

Primary Outcomes

Impact of aerobic exercise, either associated or not with NIV, by two positive pressure levels on COPD patient functionality.

Time Frame: 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 Outcomes

  • Change in oxygen consumption.(6 weeks)
  • Change in metabolic rate.(6 weeks.)
  • Change in oxygenation.(6 weeks.)
  • Change in sensation of dyspnea.(6 weeks)
  • Change in quality of life.(6 weeks.)

Study Sites (1)

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