Effect of Two Physical Training Programs on Oxygen Uptake and Heart Rate On-kinetics in Patients COPD (BVPS-123)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruna Varanda Pessoa, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01529489
First received: February 2, 2012
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Healthy
Other: Resisted/Aerobic physical training
Other: Interval physical training in elliptical equipament

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in oxygen consumption, minute ventilation, ventilatory limitation, pulmonary carbon dioxide output, metabolic rate. [ Time Frame: baseline and 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 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

  • Change in oxygenation [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in heart rate and heart rate reserve [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in dyspnea and perceived discomfort in lower limbs [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in quality of life and Daily Life Activities [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Body composition [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in BODE Index [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in exercise capacity [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 40
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Interval physical training Control group Other: Interval physical training in elliptical equipament
Control group (healthy individuals), interval physical training, elliptical equipment, oxygen uptake kinetic, heart rate kinetic.
Other Names:
  • Control group (healthy individuals),
  • interval physical training in elliptical equipment,
  • oxygen uptake kinetic,
  • heart rate kinetic.
Experimental: Resisted/Aerobic physical training group Other: Resisted/Aerobic physical training
COPD, aerobic physical training in cicloergometer, resisted physical training in cicloergometer, oxygen uptake kinetic, heart rate kinetic.
Other Names:
  • COPD,
  • aerobic physical training in cicloergometer,
  • resisted physical training in cicloergometer,
  • oxygen uptake kinetic,
  • heart rate kinetic.
Active Comparator: Aerobic/resisted physical training group Other: Resisted/Aerobic physical training
Control group, aerobic physical training in cicloergometer, resisted physical training in leg-press oxygen uptake kinetic heart rate kinetic
Other Names:
  • Control group,
  • aerobic physical training in cicloergometer,
  • resisted physical training in leg-press,
  • oxygen uptake kinetic,
  • heart rate kinetic.
Experimental: Interval physical training group
COPD, interval physical training, elliptical equipament, oxygen uptake kinetic, heart rate kinetic
Other: Interval physical training in elliptical equipament
COPD, interval physical training, elliptical equipament, oxygen uptake kinetic, heart rate kinetic
Other Names:
  • COPD,
  • interval physical training in elliptical equipament,
  • oxygen uptake kinetic,
  • heart rate kinetic.

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.
  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529489

Locations
Brazil
Federal University of sao Carlos
Sao Carlos, Sao Paulo, Brazil, 13565-905
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
Principal Investigator: Bruna V Pessoa, Ms Universidade Federal de Sao Carlos
  More Information

Publications:

Responsible Party: Bruna Varanda Pessoa, Principal Investigator, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01529489     History of Changes
Other Study ID Numbers: BVPS-123
Study First Received: February 2, 2012
Last Updated: February 6, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Sao Carlos:
Chronic Obstructive Pulmonary Disease
Physical training
Oxygen uptake kinetic
Heart rate kinetic

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014