Chronic Obstructive Pulmonary DiseaseBVPS-123NCT01529489

Effect of Two Physical Training Programs on Oxygen Uptake and Heart Rate On-kinetics in Patients COPD

A study testing Resisted/Aerobic physical training and Interval physical training in elliptical equipament in people with Chronic Obstructive Pulmonary Disease and Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease, Healthy
What is being tested?: Resisted/Aerobic physical training and Interval physical training in elliptical equipament
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteBrazil
Study dates: Jan 2008to Dec 2011
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 55 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Experimental Group:
Patients with clinical and spyrometric diagnosis of COPD presenting FEV1/FVC < 70% and FEV1 < 80% predicted by pulmonary function observed and were classified as patients with moderate to very severe obstruction (GOLD, 2010).
Clinically stable with no history infection or exacerbation of the respiratory symptoms or change in medication for two months preceding the study.
Patients were non oxygen dependent, smokers or former smokers.
No subject in the COPD group had ever participated in a pulmonary rehabilitation program (i.e., sedentary during the year preceding admission to the study).
Adherence to the individually prescribed treatment regimen.

Show all 10Show fewer

Control Group:
Pulmonary Function normal.
Subjects in the control group were free of chronic pulmonary, cardiovascular, immune, and metabolic disease.
Healthy controls who were sedentary during the year preceding admission to the study.

Who cannot join

Patients with clinical diagnosis of COPD presenting FEV1/FVC ≥ 70% FEV1 ≥ 80% predicted (GOLD, 2010).
Malignancy, orthopedic or neurological conditions affecting the ability to exercise, peripheral arterial disease, clinically apparent heart failure, and/or any renal, hepatic or inflammatory disease.
Changed the type of medication during the study.
Uncontrolled hypertension patients.
Peripheral oxygen saturation below 90% at rest.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of sao Carlos
São Carlos, São Paulo, 13565-905

Other trials in Brazil

About this study

Official title: Effect of the Combined (Aerobic/Resisted) and Interval Physical Training on Oxygen Uptake and Heart Rate On-kinetics Responses in Patients With Moderate to Very Severe COPD: Double-blind, Randomized, Controlled Trial

Patients with chronic obstructive pulmonary disease (COPD) present slowed pulmonary oxygen uptake (VO2) and heart rate (HR) kinetics compared with age-matched controls. Patients with COPD present significant loss of body mass, decreased strength and endurance of respiratory muscles and lower limbs, leading reduced exercise capacity. This reduced exercise capacity can be marked by slowed kinetics of VO2 and HR at the onset of heavy-intensity exercise. Additionally, derangements in the diffusive and convective transport of oxygen to skeletal muscle mitocondria, and intramyocyte metabolic machinery, higher ventilation and disturbances in mechanics of breathing, hypoxemia, pulmonary hemodynamics, autonomic balance, and peripheral vasodilation, and accumulation of by-products that might be related to increased muscle fatigability could slow the response of systemic (central) and peripheral (microvascular) oxygen delivery to a point where the kinetics of VO2 might become limited by O2 availability and HR. Thus, the physical training programs of the lower limbs, in addition to presenting scientific evidence "A", are important components, resulting in the reversal of the manifestations of COPD, resulting in improvement in exercise capacity, well significantly speeded VO2 and HR kinetics in patients with COPD. However, it should be taken into account the choice of an appropriate program limitations and severity of disease. Assuming that COPD patients present slower VO2 and HR kinetics, the investigators hypothesized that the heavy-intense interval physical training in equipament elliptical would promote a greater increase in the functionality (functional performance) and speeded kinetics in the cycle ergometer and elliptical equipment constant-load intense exercises tests of COPD patients. In this context, the present study intends to evaluate and compare the effects of resistive plus aerobic physical training and interval physical training on oxygen consumption (VO2) and heart rate (HR) kinetics responses at the onset in cycle ergometer and elliptical equipment constant-load intense exercises tests in patients with COPD.

Read the detailed description

Subjects performed after and before of two physical training program the following tests: lung function test,cardiopulmonary exercise testing (CPT), constant-load exercise test in cycle ergometer, Constant-load exercise test in elliptical equipament, one repetition maximum test(1RM), on alternate days.

Lung function: All patients underwent spirometry with the determination of FEV1 and FVC according to American Thoracic Society recommendations. Spirometry was performed using a COSMED microQuark PC - based Spirometer ®, (Pavona di Albano - Roma, Itália), which was calibrated before each test.
Cardiopulmonary Exercise Testing (CPT): Incremental symptom-limited exercise testing was performed on a cycle-ergometer(Ergo FIT®, model Ergo 167 Cycle, Pirmasens, Germany) using a computer-based ventilatory expired gas analysis system (VO2000, Medgraphics Corp., St. Paul, MN). All subjects underwent a CPT to determine the peak work rate and the peak oxygen uptake (peak VO2). The subjects' electrocardiographic recordings were monitored using a cardiac monitor, SpO2, BP and sensation of dyspnea and fatigue using the BE-CR-10. A gas analyzer (VO2000 Medgraphics®, St Paul MN, USA) was used to obtain the participants' VO2 at each stage of the test. The ergospirometric values were recorded by the mean value measured every three breaths using the Aerograph® program. The VO2 was determined choosing the higher and more coherent value in the final 30 seconds of each stage.
Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical equipament: The two exercise tests were performed at 70% of the previously determined work rate in CPT. During the CSET, VO2 was measured breath-by-breath and averaged every three respiration, while SpO2, HR, and the electrocardiogram were continuously monitored, and calculated a on-Kinetics of VO2 and HR.
Physical training program:
The interval physical training on the elliptical trainer (Kiko's® HM 6022, São Paulo, SP, Brazil) totalized 18 sessions that the individuals of both groups had to attend at least twice a week. Each session lasted not more than 60 minutes and they were all individual meetings. The minimal work rate of the equipment was 40W and the lower increment work rate was 10W. The elliptical trainer allowed combined exercise with the upper limb, however, in the present study, the exercise was performed with the arms fixed, and every participant's HR was monitored using a pulse frequency meter (Polar® FS2cTM Kempele, Finland), the pulse oxygen saturation (SpO2) using a pulse oximeter (Nonin®, model 8500A, Minneapolis, Mn, USA), the blood pressure (BP) using a mercury sphygmomanometer (Oxigel®, São Paulo, SP, Brazil) and the sensation of dyspnea and lower limb fatigue using the Modified Borg CR-10 Scale (BE-CR10). The elliptical exercise was an interval training and was based on studies that performed interval training exercise in cycle ergometer. This was a 30-minute exercise with a rest interval established in one minute. The exercise's work rateworkload was the maximal achieved in the CPT, and it was not modified until the sessions were finished The individuals who did not reach 40W in the CPT performed 30 seconds exercising periods at 40W with 1-minute resting interval. The volunteers who achieved workload equal or higher 40W performed 1-minute exercising periods at the workload achieved in the CPT with 1-minute resting interval. During the exercise on the equipment, the individuals should keep the speed between 40 and 50 rpm.Vital signs (HR, BP, SpO2) were recorded at the beginning and at the end of each session, as well as monitored before, during and after the elliptical exercise. During the training, the vital signs were recorded on the first 30 seconds of each resting interval.
The aerobic associate resisted physical training consisted of thirty minutes oa aerobic training at 60-70% of work rate obtained in CPT and subsequently three sets of fifteen repetitions of resistance training in lower limbs on leg press with an intensity of 40-60% of one repetition maximum test.

Conditions: Chronic Obstructive Pulmonary Disease, Healthy
Being tested: Resisted/Aerobic physical training, Interval physical training in elliptical equipament
Keywords: Chronic Obstructive Pulmonary Disease, Physical training, Oxygen uptake kinetic, Heart rate kinetic
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.

Resisted/Aerobic physical trainingOther
Also called COPD,, aerobic physical training in cicloergometer,, resisted physical training in cicloergometer,, oxygen uptake kinetic,
COPD, aerobic physical training in cicloergometer, resisted physical training in cicloergometer, oxygen uptake kinetic, heart rate kinetic.
Interval physical training in elliptical equipamentOther
Also called Control group (healthy individuals),, interval physical training in elliptical equipment,, oxygen uptake kinetic,, heart rate kinetic.
Control group (healthy individuals), interval physical training, elliptical equipment, oxygen uptake kinetic, heart rate kinetic.
Interval physical training in elliptical equipamentOther
Also called COPD,, interval physical training in elliptical equipament,, oxygen uptake kinetic,, heart rate kinetic.
COPD, interval physical training, elliptical equipament, oxygen uptake kinetic, heart rate kinetic
Resisted/Aerobic physical trainingOther
Also called Control group,, aerobic physical training in cicloergometer,, resisted physical training in leg-press,, oxygen uptake kinetic,
Control group, aerobic physical training in cicloergometer, resisted physical training in leg-press oxygen uptake kinetic heart rate kinetic

Study groups in NCT01529489
Study group	Role	What they receive
Interval physical training Control group	Active comparator	Not described Receives: Other: Interval physical training in elliptical equipament
Resisted/Aerobic physical training group	Experimental	Not described Receives: Other: Resisted/Aerobic physical training
Aerobic/resisted physical training group	Active comparator	Not described Receives: Other: Resisted/Aerobic physical training
Interval physical training group	Experimental	COPD, interval physical training, elliptical equipament, oxygen uptake kinetic, heart rate kinetic Receives: Other: Interval physical training in elliptical equipament

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of aerobic and resisted physical training and interval physical training on oxygen uptake and heart rate on-kinetics in patients with COPD.
The kinetic analysis was measured before and after interval physical training and aerobic and resisted physical training by Cardiopulmonary Exercise Testing (CPT; Incremental symptom-limited exercise testing), Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical equipament. The on-transient (first 180 seconds) response of VO2 and HR was modeled according to a monoexponencial fit.
Measured: baseline and 6 weeks

Secondary outcomes (8)

Change in oxygen consumption, minute ventilation, ventilatory limitation, pulmonary carbon dioxide output, 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 three breath method at the peak of CPT and in the peak of Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical equipament before and after interval physical training and aerobic and resisted physical training
Measured: baseline and 6 weeks
Change in oxygenation
It was evaluated through a Nonin® (modelo 2500, Minneapolis, Mn, USA)wrist pulse oxymeter at the peak of CPT and peak of Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical before and after aerobic/resisted physical training and interval physical training in elliptical equipament.
Measured: baseline and 6 weeks
Change in heart rate and heart rate reserve
It was evaluated through a Polar® cardiofrequency (Polar® FS2cTM Kempele, Finland) at the peak of CPT and peak of Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical before and after aerobic/resisted physical training and interval physical training in elliptical equipament.
Measured: baseline and 6 weeks
Change in dyspnea and perceived discomfort in lower limbs
It was evaluated through a Borg scale (BORG, 1982) at the peak of CPT and peak of Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical before and after aerobic/resisted physical training and interval physical training in elliptical equipament.
Measured: baseline and 6 weeks
Change in quality of life and Daily Life Activities
It was evaluated through a St George's Respiratory Questionnaire (SGRQ) and London Chest Activity of Daily Living Scale (LCADL)(PITTA et al, 2008; CARPES et al, 2008) before and after aerobic/resisted physical training and interval physical training in elliptical equipament.
Measured: baseline and 6 weeks
Change in Body composition
It was evaluated through a body composition monitor, evaluated weight, body fat percentage, muscle mass free, basal metabolic rate, bone mass and total body water percentage before and after aerobic/resisted physical training and interval physical training in elliptical equipament.
Measured: baseline and 6 weeks
Change in BODE Index
It was evaluated through multidimensional index comprising of Body Mass Index (BMI), degree of airway obstruction (FEV1), functional dyspnea (MRC dyspnea scale), and exercise capacity by the 6 minute walk test (6MWT). For calculation of the BODE index, we used an empirical model as previously described by Celli et al. (2004), before and after aerobic/ resisted physical training and interval physical training in elliptical equipament.
Measured: baseline and 6 weeks
Change in exercise capacity
It was evaluated through of performance obtained at the peak of CPT and in the peak of Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical equipament before and after interval physical training and aerobic and resisted physical training
Measured: baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Dec 2011

First posted8 Feb 2012 (estimated)
Study startJan 2008
Primary completionDec 2010
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (37)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01529489
Sponsor's protocol ID: BVPS-123
Acronym: BVPS-123
Status last verified: Feb 2012
First submitted: 2 Feb 2012
Last updated: 8 Feb 2012
Results posted: No
Data monitoring committee: No

Publications

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893
Dourado VZ, Tanni SE, Vale SA, Faganello MM, Sanchez FF, Godoy I. Systemic manifestations in chronic obstructive pulmonary disease. J Bras Pneumol. 2006 Mar-Apr;32(2):161-71. doi: 10.1590/s1806-37132006000200012. English, Portuguese.
PubMed 17273586
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.
PubMed 17507545
Knudson RJ, Lebowitz MD, Holberg CJ, Burrows B. Changes in the normal maximal expiratory flow-volume curve with growth and aging. Am Rev Respir Dis. 1983 Jun;127(6):725-34. doi: 10.1164/arrd.1983.127.6.725.
PubMed 6859656
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 9154855
Nasis IG, Vogiatzis I, Stratakos G, Athanasopoulos D, Koutsoukou A, Daskalakis A, Spetsioti S, Evangelodimou A, Roussos C, Zakynthinos S. Effects of interval-load versus constant-load training on the BODE index in COPD patients. Respir Med. 2009 Sep;103(9):1392-8. doi: 10.1016/j.rmed.2009.03.003. Epub 2009 Apr 5.
PubMed 19349153
Vogiatzis I, Nanas S, Roussos C. Interval training as an alternative modality to continuous exercise in patients with COPD. Eur Respir J. 2002 Jul;20(1):12-9. doi: 10.1183/09031936.02.01152001.
PubMed 12166558
Kortianou EA, Nasis IG, Spetsioti ST, Daskalakis AM, Vogiatzis I. Effectiveness of Interval Exercise Training in Patients with COPD. Cardiopulm Phys Ther J. 2010 Sep;21(3):12-9.
PubMed 20957074
Franssen FM, Broekhuizen R, Janssen PP, Wouters EF, Schols AM. Effects of whole-body exercise training on body composition and functional capacity in normal-weight patients with COPD. Chest. 2004 Jun;125(6):2021-8. doi: 10.1378/chest.125.6.2021.
PubMed 15189917
Spruit MA, Gosselink R, Troosters T, De Paepe K, Decramer M. Resistance versus endurance training in patients with COPD and peripheral muscle weakness. Eur Respir J. 2002 Jun;19(6):1072-8. doi: 10.1183/09031936.02.00287102.
PubMed 12108859
Panton LB, Golden J, Broeder CE, Browder KD, Cestaro-Seifer DJ, Seifer FD. The effects of resistance training on functional outcomes in patients with chronic obstructive pulmonary disease. Eur J Appl Physiol. 2004 Apr;91(4):443-9. doi: 10.1007/s00421-003-1008-y. Epub 2003 Nov 25.
PubMed 14639479
Misic MM, Valentine RJ, Rosengren KS, Woods JA, Evans EM. Impact of training modality on strength and physical function in older adults. Gerontology. 2009;55(4):411-6. doi: 10.1159/000227804. Epub 2009 Jul 3.
PubMed 19590159
Egana M, Donne B. Physiological changes following a 12 week gym based stair-climbing, elliptical trainer and treadmill running program in females. J Sports Med Phys Fitness. 2004 Jun;44(2):141-6.
PubMed 15470311
Kim JK, Nho H, H Whaley M. Inter-modal comparisons of acute energy expenditure during perceptually based exercise in obese adults. J Nutr Sci Vitaminol (Tokyo). 2008 Feb;54(1):39-45. doi: 10.3177/jnsv.54.39.
PubMed 18388406

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of the Combined (Aerobic/Resisted) and Interval Physical Training on Oxygen Uptake and Heart Rate On-kinetics Responses in Patients With Moderate to Very Severe COPD: Double-blind, Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT01529489
Acronym / sponsor ID: BVPS-123 / BVPS-123
Conditions: Chronic Obstructive Pulmonary Disease, Healthy
Keywords: Chronic Obstructive Pulmonary Disease, Physical training, Oxygen uptake kinetic, Heart rate kinetic
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Universidade Federal de Sao CarlosUniversity, hospital or other
Study start: Jan 2008
Primary completion: Dec 2010 (actual)
Study completion: Dec 2011 (actual)
First posted: 8 Feb 2012 (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.

Detailed description

Lung function: All patients underwent spirometry with the determination of FEV1 and FVC according to American Thoracic Society recommendations. Spirometry was performed using a COSMED microQuark PC - based Spirometer ®, (Pavona di Albano - Roma, Itália), which was calibrated before each test.
Cardiopulmonary Exercise Testing (CPT): Incremental symptom-limited exercise testing was performed on a cycle-ergometer(Ergo FIT®, model Ergo 167 Cycle, Pirmasens, Germany) using a computer-based ventilatory expired gas analysis system (VO2000, Medgraphics Corp., St. Paul, MN). All subjects underwent a CPT to determine the peak work rate and the peak oxygen uptake (peak VO2). The subjects' electrocardiographic recordings were monitored using a cardiac monitor, SpO2, BP and sensation of dyspnea and fatigue using the BE-CR-10. A gas analyzer (VO2000 Medgraphics®, St Paul MN, USA) was used to obtain the participants' VO2 at each stage of the test. The ergospirometric values were recorded by the mean value measured every three breaths using the Aerograph® program. The VO2 was determined choosing the higher and more coherent value in the final 30 seconds of each stage.
Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical equipament: The two exercise tests were performed at 70% of the previously determined work rate in CPT. During the CSET, VO2 was measured breath-by-breath and averaged every three respiration, while SpO2, HR, and the electrocardiogram were continuously monitored, and calculated a on-Kinetics of VO2 and HR.
Physical training program:
The interval physical training on the elliptical trainer (Kiko's® HM 6022, São Paulo, SP, Brazil) totalized 18 sessions that the individuals of both groups had to attend at least twice a week. Each session lasted not more than 60 minutes and they were all individual meetings. The minimal work rate of the equipment was 40W and the lower increment work rate was 10W. The elliptical trainer allowed combined exercise with the upper limb, however, in the present study, the exercise was performed with the arms fixed, and every participant's HR was monitored using a pulse frequency meter (Polar® FS2cTM Kempele, Finland), the pulse oxygen saturation (SpO2) using a pulse oximeter (Nonin®, model 8500A, Minneapolis, Mn, USA), the blood pressure (BP) using a mercury sphygmomanometer (Oxigel®, São Paulo, SP, Brazil) and the sensation of dyspnea and lower limb fatigue using the Modified Borg CR-10 Scale (BE-CR10). The elliptical exercise was an interval training and was based on studies that performed interval training exercise in cycle ergometer. This was a 30-minute exercise with a rest interval established in one minute. The exercise's work rateworkload was the maximal achieved in the CPT, and it was not modified until the sessions were finished The individuals who did not reach 40W in the CPT performed 30 seconds exercising periods at 40W with 1-minute resting interval. The volunteers who achieved workload equal or higher 40W performed 1-minute exercising periods at the workload achieved in the CPT with 1-minute resting interval. During the exercise on the equipment, the individuals should keep the speed between 40 and 50 rpm.Vital signs (HR, BP, SpO2) were recorded at the beginning and at the end of each session, as well as monitored before, during and after the elliptical exercise. During the training, the vital signs were recorded on the first 30 seconds of each resting interval.
The aerobic associate resisted physical training consisted of thirty minutes oa aerobic training at 60-70% of work rate obtained in CPT and subsequently three sets of fifteen repetitions of resistance training in lower limbs on leg press with an intensity of 40-60% of one repetition maximum test.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Interval physical training Control group	Active comparator	Other: Interval physical training in elliptical equipament
Resisted/Aerobic physical training group	Experimental	Other: Resisted/Aerobic physical training
Aerobic/resisted physical training group	Active comparator	Other: Resisted/Aerobic physical training
Interval physical training group	Experimental	Other: Interval physical training in elliptical equipamentCOPD, interval physical training, elliptical equipament, oxygen uptake kinetic, heart rate kinetic

Who may qualify

Ages: 55 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Experimental Group:
Control Group:

Key exclusion criteria (5 listed)

Patients with clinical diagnosis of COPD presenting FEV1/FVC ≥ 70% FEV1 ≥ 80% predicted (GOLD, 2010).
Malignancy, orthopedic or neurological conditions affecting the ability to exercise, peripheral arterial disease, clinically apparent heart failure, and/or any renal, hepatic or inflammatory disease.
Changed the type of medication during the study.
Uncontrolled hypertension patients.
Peripheral oxygen saturation below 90% at rest.

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
Resisted/Aerobic physical trainingAlso: COPD,, aerobic physical training in cicloergometer,, resisted physical training in cicloergometer,, oxygen uptake kinetic,COPD, aerobic physical training in cicloergometer, resisted physical training in cicloergometer, oxygen uptake kinetic, heart rate kinetic.	Other	Resisted/Aerobic physical training group
Interval physical training in elliptical equipamentAlso: Control group (healthy individuals),, interval physical training in elliptical equipment,, oxygen uptake kinetic,, heart rate kinetic.Control group (healthy individuals), interval physical training, elliptical equipment, oxygen uptake kinetic, heart rate kinetic.	Other	Interval physical training Control group
Interval physical training in elliptical equipamentAlso: COPD,, interval physical training in elliptical equipament,, oxygen uptake kinetic,, heart rate kinetic.COPD, interval physical training, elliptical equipament, oxygen uptake kinetic, heart rate kinetic	Other	Interval physical training group
Resisted/Aerobic physical trainingAlso: Control group,, aerobic physical training in cicloergometer,, resisted physical training in leg-press,, oxygen uptake kinetic,Control group, aerobic physical training in cicloergometer, resisted physical training in leg-press oxygen uptake kinetic heart rate kinetic	Other	Aerobic/resisted physical training group

Primary outcome

Effect of aerobic and resisted physical training and interval physical training on oxygen uptake and heart rate on-kinetics in patients with COPD.
Time frame: baseline and 6 weeks
The kinetic analysis was measured before and after interval physical training and aerobic and resisted physical training by Cardiopulmonary Exercise Testing (CPT; Incremental symptom-limited exercise testing), Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical equipament. The on-transient (first 180 seconds) response of VO2 and HR was modeled according to a monoexponencial fit.

8 secondary outcomes

Change in oxygen consumption, minute ventilation, ventilatory limitation, pulmonary carbon dioxide output, metabolic rate.
Time frame: baseline and 6 weeks
Change in oxygenation
Time frame: baseline and 6 weeks
Change in heart rate and heart rate reserve
Time frame: baseline and 6 weeks
Change in dyspnea and perceived discomfort in lower limbs
Time frame: baseline and 6 weeks
Change in quality of life and Daily Life Activities
Time frame: baseline and 6 weeks
Change in Body composition
Time frame: baseline and 6 weeks
Change in BODE Index
Time frame: baseline and 6 weeks
Change in exercise capacity
Time frame: baseline and 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 8 Feb 2012.
Results publication: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Results publication: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Results publication: PubMed 17273586Dourado VZ, Tanni SE, Vale SA, Faganello MM, Sanchez FF, Godoy I. Systemic manifestations in chronic obstructive pulmonary disease. J Bras Pneumol. 2006 Mar-Apr;32(2):161-71. doi: 10.1590/s1806-37132006000200012. English, Portuguese.
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 6859656Knudson RJ, Lebowitz MD, Holberg CJ, Burrows B. Changes in the normal maximal expiratory flow-volume curve with growth and aging. Am Rev Respir Dis. 1983 Jun;127(6):725-34. doi: 10.1164/arrd.1983.127.6.725.
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 19349153Nasis IG, Vogiatzis I, Stratakos G, Athanasopoulos D, Koutsoukou A, Daskalakis A, Spetsioti S, Evangelodimou A, Roussos C, Zakynthinos S. Effects of interval-load versus constant-load training on the BODE index in COPD patients. Respir Med. 2009 Sep;103(9):1392-8. doi: 10.1016/j.rmed.2009.03.003. Epub 2009 Apr 5.
Results publication: PubMed 12166558Vogiatzis I, Nanas S, Roussos C. Interval training as an alternative modality to continuous exercise in patients with COPD. Eur Respir J. 2002 Jul;20(1):12-9. doi: 10.1183/09031936.02.01152001.
Results publication: PubMed 20957074Kortianou EA, Nasis IG, Spetsioti ST, Daskalakis AM, Vogiatzis I. Effectiveness of Interval Exercise Training in Patients with COPD. Cardiopulm Phys Ther J. 2010 Sep;21(3):12-9.
Results publication: PubMed 15189917Franssen FM, Broekhuizen R, Janssen PP, Wouters EF, Schols AM. Effects of whole-body exercise training on body composition and functional capacity in normal-weight patients with COPD. Chest. 2004 Jun;125(6):2021-8. doi: 10.1378/chest.125.6.2021.
Results publication: PubMed 12108859Spruit MA, Gosselink R, Troosters T, De Paepe K, Decramer M. Resistance versus endurance training in patients with COPD and peripheral muscle weakness. Eur Respir J. 2002 Jun;19(6):1072-8. doi: 10.1183/09031936.02.00287102.
Results publication: PubMed 14639479Panton LB, Golden J, Broeder CE, Browder KD, Cestaro-Seifer DJ, Seifer FD. The effects of resistance training on functional outcomes in patients with chronic obstructive pulmonary disease. Eur J Appl Physiol. 2004 Apr;91(4):443-9. doi: 10.1007/s00421-003-1008-y. Epub 2003 Nov 25.

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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.

Bruna V Pessoa, Ms principal investigator

Universidade Federal de Sao Carlos

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 5 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 8 Feb 2012. 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?

Effect of aerobic and resisted physical training and interval physical training on oxygen uptake and heart rate on-kinetics in patients with COPD. (time frame: baseline and 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 NCT01529489, which also lists 37 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 8 Feb 2012.