Chronic Obstructive Pulmonary Disease (COPD)kmarraraNCT01464736
Noninvasive Ventilation on Chronic Obstructive Pulmonary Disease (COPD) Patient Functionality
A study testing physical training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 60 to 80 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos - UFSCar.
São Carlos, São Paulo, 676
About this study
Official title: 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).
Read the 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.
- Being tested
- physical training
- Keywords
- aerobic exercise, noninvasive ventilation, functionality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical trainingOther
Also called TFG: physical training group, PTGNIV: exercise plus bilevel ventilation group
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Training Group | Experimental | This group performed aerobic physical training in treadmill. Receives: 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. Receives: Other: physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (5)
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.
Measured: 6 weeks
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.
Measured: 6 weeks.
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.
Measured: 6 weeks.
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.
Measured: 6 weeks
Change in quality of life.
It was evaluated through the SF-36 (domains: physical functioning, role-physical, and vitality).
Measured: 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startJan 2006
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamilla Tays Marrara, Universidade Federal de Sao Carlos
- Investigators
- Kamilla T Marrara, Doutoranda, Principal investigator, Universidade Federal de São Carlos - UFSCar.Diego M Marino, Doutorando, Study chair, Universidade Federal de São Carlos - UFSCar.Maurício Jamami, Professor, Study chair, Universidade Federal de São Carlos - UFSCar.Antônio D Oliveira Junior, Médico, Study chair, Santa Casa de Misericórdia de São CarlosValéria A Pires Di Lorenzo, Professora, Study director, Universidade Federal de São Carlos - UFSCar.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464736
- Sponsor's protocol ID
- UFSCar
- Acronym
- kmarrara
- Status last verified
- Oct 2011
- First submitted
- 27 Oct 2011
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1164/ajrccm.155.5.9154855.
PubMed 9154855Costes 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.
PubMed 12894005Maltais 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.
PubMed 8542131Ambrosino 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.
PubMed 15332404Toledo 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.
PubMed 17505694Zuwallack R. Physical activity in patients with COPD: the role of pulmonary rehabilitation. Pneumonol Alergol Pol. 2009;77(1):72-6. No abstract available.
PubMed 19308913van '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.
PubMed 16387937Rabe 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.
PubMed 17507545Puhan 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.
PubMed 18550610Marrara 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.
PubMed 18242069Brochard 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.
PubMed 7651472Brochard 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.
PubMed 10992531
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Physical Training Associated With Noninvasive Ventilation on COPD Patient Functionality - A Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT01464736
- Acronym / sponsor ID
- kmarrara / UFSCar
- Keywords
- aerobic exercise, noninvasive ventilation, functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Training Group | Experimental | Other: physical trainingThis group performed aerobic physical training in treadmill. |
| NIV Trained | Experimental | Other: physical trainingThis 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical trainingAlso: TFG: physical training group, PTGNIV: exercise plus bilevel ventilation groupFor 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 | NIV Trained, Physical Training Group |
Primary outcome
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.
5 secondary outcomes
Change in oxygen consumption.
Time frame: 6 weeks
Change in metabolic rate.
Time frame: 6 weeks.
Change in oxygenation.
Time frame: 6 weeks.
Change in sensation of dyspnea.
Time frame: 6 weeks
Change in quality of life.
Time frame: 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2011.
- Results publication: PubMed 9154855Casaburi 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.
- Results publication: PubMed 12894005Costes 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.
- Results publication: PubMed 8542131Maltais 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.
- Results publication: PubMed 15332404Ambrosino 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.
- Results publication: PubMed 17505694Toledo 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.
- Results publication: PubMed 19308913Zuwallack R. Physical activity in patients with COPD: the role of pulmonary rehabilitation. Pneumonol Alergol Pol. 2009;77(1):72-6. No abstract available.
- Results publication: PubMed 16387937van '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.
- Results publication: PubMed 17507545Rabe 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.
- Results publication: PubMed 18550610Puhan 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.
- Results publication: PubMed 18242069Marrara 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.
- Results publication: PubMed 7651472Brochard 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.
- Results publication: PubMed 10992531Brochard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamilla T Marrara, Doutoranda principal investigator
Universidade Federal de São Carlos - UFSCar.
Diego M Marino, Doutorando study chair
Universidade Federal de São Carlos - UFSCar.
Maurício Jamami, Professor study chair
Universidade Federal de São Carlos - UFSCar.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of aerobic exercise, either associated or not with NIV, by two positive pressure levels on COPD patient functionality. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01464736, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2011.