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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— kmarrara  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464736
• Other study ID #: UFSCar
• Status: Completed
• Phase: N/A
• First received: October 27, 2011
• Last updated: October 31, 2011
• Start date: January 2006
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos - UFSCar.	São Carlos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

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. — View Citation

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. — View Citation

Brochard L. Non-invasive ventilation for acute exacerbations of COPD: a new standard of care. Thorax. 2000 Oct;55(10):817-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1016/j.rmed.2007 — View Citation

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. doi: 10.1183/09031936.00140507. Epub 2008 Jun 11. — View Citation

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 chron — View Citation

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( — View Citation

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. — View Citation

Zuwallack R. Physical activity in patients with COPD: the role of pulmonary rehabilitation. Pneumonol Alergol Pol. 2009;77(1):72-6. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks	No
Secondary	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.	6 weeks	No
Secondary	Change in metabolic rate.	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.	No
Secondary	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.	6 weeks.	No
Secondary	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.	6 weeks	No
Secondary	Change in quality of life.	It was evaluated through the SF-36 (domains: physical functioning, role-physical, and vitality).	6 weeks.	No