Noninvasive Ventilation on Chronic Obstructive Pulmonary Disease (COPD) Patient Functionality - Full Text View

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

U.S. FDA Resources

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

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

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:

Casaburi R, Porszasz J, Burns MR, Carithers ER, Chang RS, Cooper CB. Physiologic benefits of exercise training in rehabilitation of patients with severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 May;155(5):1541-51.

Costes F, Agresti A, Court-Fortune I, Roche F, Vergnon JM, Barthélémy JC. Noninvasive ventilation during exercise training improves exercise tolerance in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2003 Jul-Aug;23(4):307-13.

Maltais F, Simard AA, Simard C, Jobin J, Desgagnés P, LeBlanc P. Oxidative capacity of the skeletal muscle and lactic acid kinetics during exercise in normal subjects and in patients with COPD. Am J Respir Crit Care Med. 1996 Jan;153(1):288-93.

Ambrosino N, Strambi S. New strategies to improve exercise tolerance in chronic obstructive pulmonary disease. Eur Respir J. 2004 Aug;24(2):313-22. Review.

Toledo A, Borghi-Silva A, Sampaio LM, Ribeiro KP, Baldissera V, Costa D. The impact of noninvasive ventilation during the physical training in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Clinics (Sao Paulo). 2007 Apr;62(2):113-20.

Zuwallack R. Physical activity in patients with COPD: the role of pulmonary rehabilitation. Pneumonol Alergol Pol. 2009;77(1):72-6. Review. No abstract available.

van 't Hul A, Gosselink R, Hollander P, Postmus P, Kwakkel G. Training with inspiratory pressure support in patients with severe COPD. Eur Respir J. 2006 Jan;27(1):65-72.

Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. Epub 2007 May 16. Review.

Puhan MA, Mador MJ, Held U, Goldstein R, Guyatt GH, Schünemann HJ. Interpretation of treatment changes in 6-minute walk distance in patients with COPD. Eur Respir J. 2008 Sep;32(3):637-43. Epub 2008 Jun 11.

Marrara KT, Marino DM, de Held PA, de Oliveira Junior AD, Jamami M, Di Lorenzo VA. Different physical therapy interventions on daily physical activities in chronic obstructive pulmonary disease. Respir Med. 2008 Apr;102(4):505-11. Epub 2008 Feb 1.

Brochard L, Mancebo J, Wysocki M, Lofaso F, Conti G, Rauss A, Simonneau G, Benito S, Gasparetto A, Lemaire F, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995 Sep 28;333(13):817-22.

Brochard L. Non-invasive ventilation for acute exacerbations of COPD: a new standard of care. Thorax. 2000 Oct;55(10):817-8. No abstract available.

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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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