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

October 31, 2011 updated by: Kamilla Tays Marrara, Universidade Federal de Sao Carlos

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 676
        • Universidade Federal de São Carlos - UFSCar.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

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.
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks.
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.
6 weeks.
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.
6 weeks
Change in quality of life.
Time Frame: 6 weeks.
It was evaluated through the SF-36 (domains: physical functioning, role-physical, and vitality).
6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

November 3, 2011

Last Update Submitted That Met QC Criteria

October 31, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFSCar

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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