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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kamilla Tays Marrara, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01464736
First received: October 27, 2011
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Other: physical training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Aerobic Physical Training Associated With Noninvasive Ventilation on COPD Patient Functionality - A Controlled Randomized Study

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • Impact of aerobic exercise, either associated or not with NIV, by two positive pressure levels on COPD patient functionality. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    It was measured by means of step-climbing repetitions and distance covered in the six-minute walk test as well as the CPT.


Secondary Outcome Measures:
  • Change in oxygen consumption. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 metabolic rate. [ Time Frame: 6 weeks. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 weeks. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in quality of life. [ Time Frame: 6 weeks. ] [ Designated as safety issue: No ]
    It was evaluated through the SF-36 (domains: physical functioning, role-physical, and vitality).


Enrollment: 23
Study Start Date: January 2006
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Training Group
This group performed aerobic physical training in treadmill.
Other: physical 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.
Other Names:
  • TFG: physical training group
  • PTGNIV: exercise plus bilevel ventilation group
Experimental: NIV Trained

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
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

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

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01464736

Locations
Brazil
Universidade Federal de São Carlos - UFSCar.
São Carlos, São Paulo, Brazil, 676
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
Principal Investigator: Kamilla T Marrara, Doutoranda Universidade Federal de São Carlos - UFSCar.
Study Chair: Diego M Marino, Doutorando Universidade Federal de São Carlos - UFSCar.
Study Chair: Maurício Jamami, Professor Universidade Federal de São Carlos - UFSCar.
Study Chair: Antônio D Oliveira Junior, Médico Santa Casa de Misericórdia de São Carlos
Study Director: Valéria A Pires Di Lorenzo, Professora Universidade Federal de São Carlos - UFSCar.
  More Information

Publications:

Responsible Party: Kamilla Tays Marrara, Doutoranda em Fisioterapia pela Universidade Federal de São Carlos - UFSCar., Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01464736     History of Changes
Other Study ID Numbers: UFSCar
Study First Received: October 27, 2011
Last Updated: October 31, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Sao Carlos:
aerobic exercise
noninvasive ventilation
functionality

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014