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Completed

NCT Number: NCT01464736

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

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

60 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de São Carlos - UFSCar.

São Carlos, São Paulo, 676, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical training

Other

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.

Other names: TFG: physical training group, PTGNIV: exercise plus bilevel ventilation group

Primary outcomes

  1. 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

  1. Change in oxygen consumption.

    Time frame: 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.

  2. Change in metabolic rate.

    Time frame: 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.

  3. Change in oxygenation.

    Time frame: 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.

  4. Change in sensation of dyspnea.

    Time frame: 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.

  5. Change in quality of life.

    Time frame: 6 weeks.

    It was evaluated through the SF-36 (domains: physical functioning, role-physical, and vitality).

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Registry information

Official study title

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

Acronym: kmarrara

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 3, 2011
Registry last updated
Nov 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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