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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

physical training

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring aerobic exercise, noninvasive ventilation, functionality

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Universidade Federal de São Carlos - UFSCar.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Physical Training Group

NIV Trained

Arm Description

This group performed aerobic physical training in treadmill.

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.

Outcomes

Primary Outcome Measures

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

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.

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.

Change in oxygenation.

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.

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.

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

Full Information

NCT ID

NCT01464736

First Posted

October 27, 2011

Last Updated

October 31, 2011

Sponsor

Universidade Federal de Sao Carlos

1. Study Identification

Unique Protocol Identification Number

NCT01464736

Brief Title

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

Acronym

kmarrara

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Sao Carlos

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

aerobic exercise, noninvasive ventilation, functionality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical Training Group

Arm Type

Experimental

Arm Description

This group performed aerobic physical training in treadmill.

Arm Title

NIV Trained

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

physical training

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

It was measured by means of step-climbing repetitions and distance covered in the six-minute walk test as well as the CPT.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change in oxygen consumption.

Description

Time Frame

6 weeks

Title

Change in metabolic rate.

Description

Time Frame

6 weeks.

Title

Change in oxygenation.

Description

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.

Time Frame

6 weeks.

Title

Change in sensation of dyspnea.

Description

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.

Time Frame

6 weeks

Title

Change in quality of life.

Description

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

Time Frame

6 weeks.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: