Hospital Universitario Virgen del Rocio
Seville, Sevilla, 41013, Spain
NCT Number: NCT01336283
Aims: To prove the benefits of an specific strength training program in COPD patients compared to those achieved with the traditional endurance training. We will assess which is the proper training modality and which of them is the most beneficial according to the features of the patient to whom it is applied.
Subjects and Methods: We will study 66 patients diagnosed of COPD with a moderate-severe obstruction (FEV1<60%) and clinically symptomatic. The monitoring will be done for 3 moths. Patients will be differentiated between COPD with "predominant chronic bronchitis" and COPD with "predominant emphysema", with regard to clinical, functional and radiological criteria. After stratification of the sample, patients will be prospectively assigned to three groups of 22 patients each: a) Endurance training group, on cycle ergometer at a workload of 70% VO2max. b) Strength training group, with 5 different weightlifting exercises (4 sets of 6-8 repetitions). c) Mixed training group, with half the time dedicated to each type of training. Training will be developed during 12 weeks, three times per week, in 40 minutes sessions. Analysed variables, at the beginning and at the end of program will be: Chest X-ray, basic blood analyses, electrocardiogram, simple spirometry and bronchodilator test, blood gases, static pulmonary volumes, diffusion measurement and respiratory muscle pressure. Muscle strength will be assessed by means of 1RM test and the Myometer® dynamometer. Using the muscle skeletal ultrasound, we will control changes in muscle fibre size. Maximal and submaximal exercise tests on cycle ergometer will be also performed, so as a walking test (shuttle walking test). At last, we will assess treatment effect on dyspnea (Mahler's test) and quality of life (CRDQ).
Hypothesis: A strength training program would significantly increase peripheral muscle power. This type of training would mainly have effect on the "predominant emphysema" COPD patient, where the important weight lost causes a decrease in muscle strength.
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Notify Me45 year–80 year
All sexes
Interventional
Phase 4
Seville, Sevilla, 41013, Spain
After stratification of the sample will be included in a prospective and randomized into three groups of 22 patients:
Trained group 1, resistance 2 nd Group trained force 3 º Group Joint trained to strength and endurance
CT scan (Phillips TomoScan with Easy Vision workstation version 4.2) which allows densitometric analysis of lung parenchyma.
Assessment of dyspnea and quality of life:
The training of the different groups were carried out for 12 weeks, three times per week in sessions of 40 minutes duration.
Resistance is increased gradually from 50% of the maximum weight you can lift the patient on one occasion, early in the week, up to 85%. Every two weeks the weight limit is reassessed to adjust the training load in each patient (Test 1 RM).
Upon completion of 12 weeks of training will be repeated all baseline tests (except for chest CT) and compared the results.
Analyzing the effect size at the expense of an improvement in work reached more than about 15 W in the stress test, considered a standard deviation of this parameter of ± 10 W, an alpha of 0.05 and a beta of 0.1 (statistical power 90%) and calculating a loss ratio of 15%, we estimate a sample size of 22 patients for each group.
Comparing before and after the training response in each group were performed using the paired t test. Comparisons between trained groups were made using analysis of variance (ANOVA). The Pearson correlation coefficient and linear regression analysis will allow to examine relationships between physiological variables. Be considered significant at p <0.05. The dispersion of a mean value is expressed as mean ± standard deviation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other names: Respiratory rehabilitation
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other names: Respiratory Rehabilitation
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other names: Respiratory Rehabilitation
Time frame: Parameters will be measured at baseline and end of follow-up period of 12 months
Check that exercise training increases the tolerance time of submaximal test
Time frame: Parameters will be measured at baseline and end of follow-up period of 12 months
Check that exercise training increases the distance stroll on the walking test
Time frame: Parameters will be measured at baseline and end of follow-up period of 12 months
Increased peripheral muscle strength (1RM test) after training exercise
Time frame: Parameters will be measured at baseline and end of follow-up period of 12 months
better control of symptoms (BDI test) after exercise training
Time frame: Parameters will be measured at baseline and end of follow-up period of 12 months
better quality of life (CRQ) after exercise training
Hospitales Universitarios Virgen del Rocío
Other
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