Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fondo de Investigacion Sanitaria | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Population: Patients with COPD diagnosed according to criteria established by the ATS (American Thoracic Society) and the SEPAR (Spanish Society of Pneumology and Thoracic Surgery) to submit a modereda-severe obstruction to airflow. (FEV1 <60%) and a clinical impact of their disease.
Sample: 66 patients diagnosed at the Department of Pulmonology, Hospital Virgen del RocÃo de Sevilla, informed consent.
Exclusion criteria:
Study groups: patients will differ in COPD "prevalence chronic bronchitis " or COPD "prevalence emphysema, " according to the criteria allowed by the SEPAR and ATS.
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
Variables: Parameters will be measured at baseline and end of follow-up period of 12 months.
CT scan (Phillips TomoScan with Easy Vision workstation version 4.2) which allows densitometric analysis of lung parenchyma.
Estimation of muscle strength:
Two-dimensional ultrasound of the quadriceps muscle and biceps to measure the size of muscle fibers. Probes will be used for external parts with a frequency of 7.5 MHz measurements were made from the skin depth to each of the different muscles and the thickness of each of them.
Stress Test:
Assessment of dyspnea and quality of life:
Study design:
The training of the different groups were carried out for 12 weeks, three times per week in sessions of 40 minutes duration.
The resistance training will take place in cycle ergometer with a level of initial charge of about 70% of initial maximal oxygen consumption, increasing the load every two weeks as tolerated.
The strength training with weight lifting practice and will consist of 4 sets of 6-8 repetitions of simple exercises. These are held at a station multigimnástica (CLASSIC Fitness Center, KETTLER) and are:
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).
In the group that carried out the joint training, half the time of each session will be devoted to strength training, following the same methodology (same number of years but with two sets of each), and the other half training resistance bike, beginning with one or the other interchangeably.
Upon completion of 12 weeks of training will be repeated all baseline tests (except for chest CT) and compared the results.
Exit criteria of the study:
Statistical analysis:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD with emphysema | Active Comparator | Analyze what type of training is more appropriate and beneficial as the patient characteristics that apply to you. |
|
| COPD non-emphysema | Active Comparator | compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurance training | Other | compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in minute submaximal exercise test | Check that exercise training increases the tolerance time of submaximal test | Parameters will be measured at baseline and end of follow-up period of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Meters increased 6-minute test after training exercise | Check that exercise training increases the distance stroll on the walking test | Parameters will be measured at baseline and end of follow-up period of 12 months |
| Kg increase in the 1RM test after training exercise |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ortega F Ruiz, Doctor | Hospitales Universitarios Virgen del RocÃo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocio | Seville | Sevilla | 41013 | Spain |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D000076663 | Endurance Training |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Strength training | Other | compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD. |
|
|
| Combined training | Other | compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD. |
|
|
Increased peripheral muscle strength (1RM test) after training exercise |
| Parameters will be measured at baseline and end of follow-up period of 12 months |
| Improvement in dyspnea with a fall of one point in the BDI | better control of symptoms (BDI test) after exercise training | Parameters will be measured at baseline and end of follow-up period of 12 months |
| Improved quality of life (CRQ) of at least one point (clinically significant) after exercise training | better quality of life (CRQ) after exercise training | Parameters will be measured at baseline and end of follow-up period of 12 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |