NCT01464736

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
Last Updated

November 3, 2011

Status Verified

October 1, 2011

Enrollment Period

4.8 years

First QC Date

October 27, 2011

Last Update Submit

October 31, 2011

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

aerobic exercisenoninvasive ventilationfunctionality

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Change in oxygen consumption.

    6 weeks

  • Change in metabolic rate.

    6 weeks.

  • Change in oxygenation.

    6 weeks.

  • Change in sensation of dyspnea.

    6 weeks

  • Change in quality of life.

    6 weeks.

Study Arms (2)

Physical Training Group

EXPERIMENTAL

This group performed aerobic physical training in treadmill.

Other: physical training

NIV Trained

EXPERIMENTAL

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

Interventions

physical trainingOTHER

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.

Also known as: TFG: physical training group, PTGNIV: exercise plus bilevel ventilation group
NIV TrainedPhysical Training Group

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Carlos - UFSCar.

São Carlos, São Paulo, 676, Brazil

Location

Related Publications (12)

  • 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. doi: 10.1164/ajrccm.155.5.9154855.

    PMID: 9154855RESULT

  • Costes F, Agresti A, Court-Fortune I, Roche F, Vergnon JM, Barthelemy 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. doi: 10.1097/00008483-200307000-00008.

    PMID: 12894005RESULT

  • Maltais F, Simard AA, Simard C, Jobin J, Desgagnes 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. doi: 10.1164/ajrccm.153.1.8542131.

    PMID: 8542131RESULT

  • Ambrosino N, Strambi S. New strategies to improve exercise tolerance in chronic obstructive pulmonary disease. Eur Respir J. 2004 Aug;24(2):313-22. doi: 10.1183/09031936.04.00002904.

    PMID: 15332404RESULT

  • 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. doi: 10.1590/s1807-59322007000200004.

    PMID: 17505694RESULT

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

    PMID: 19308913RESULT

  • 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. doi: 10.1183/09031936.06.00036505.

    PMID: 16387937RESULT

  • 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. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.

    PMID: 17507545RESULT

  • Puhan MA, Mador MJ, Held U, Goldstein R, Guyatt GH, Schunemann 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.

    PMID: 18550610RESULT

  • 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.2007.12.004. Epub 2008 Feb 1.

    PMID: 18242069RESULT

  • 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. doi: 10.1056/NEJM199509283331301.

    PMID: 7651472RESULT

  • Brochard L. Non-invasive ventilation for acute exacerbations of COPD: a new standard of care. Thorax. 2000 Oct;55(10):817-8. doi: 10.1136/thorax.55.10.817. No abstract available.

    PMID: 10992531RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kamilla T Marrara, Doutoranda

    Universidade Federal de São Carlos - UFSCar.

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

  • Valéria A Pires Di Lorenzo, Professora

    Universidade Federal de São Carlos - UFSCar.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doutoranda em Fisioterapia pela Universidade Federal de São Carlos - UFSCar.

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 3, 2011

Study Start

January 1, 2006

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

November 3, 2011

Record last verified: 2011-10

Locations

BR(1)