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Obstructive Chronic Pulmonary DiseasePhase 4NCT01336283

Effectiveness of Different Exercise Training Programs to the Profile of COPD Patients

A Phase 4 study testing Endurance training, Strength training and Combined training in people with Obstructive Chronic Pulmonary Disease and Emphysema, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.

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

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. Read more about this study

Who is it for?
Ages 45 to 80 years
What is being tested?
Endurance training, Strength training and Combined training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSpain
Study dates
Mar 2003to Dec 2010
Phase
Phase 4
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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with COPD diagnosed according to criteria established by the A.. TS (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.

Who cannot join

  • other cardiorespiratory diseases.
  • Systemic diseases
  • Inability or discomfort to participate in an exercise program

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario Virgen del Rocio

    Seville, Sevilla, 41013

Other trials in Spain

About this study

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.

Read the detailed description
  1. 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.
  2. Sample: 66 patients diagnosed at the Department of Pulmonology, Hospital Virgen del Rocío de Sevilla, informed consent.
  3. Exclusion criteria:
  • other cardiorespiratory diseases.
  • Systemic diseases
  • Inability or discomfort to participate in an exercise program
  1. 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
  2. Variables: Parameters will be measured at baseline and end of follow-up period of 12 months.
  • CXR, elementary analysis, 12-lead electrocardiogram
  • simple spirometry and bronchodilator test
  • Blood gases
  • static lung volumes (FRC, RV, TLC) by plethysmography.
  • Study of diffusion (DLCO) by single breath technique
  • maximum muscle pressures both inspiratory and expiratory. CT scan (Phillips TomoScan with Easy Vision workstation version 4.2) which allows densitometric analysis of lung parenchyma.
  • Estimation of muscle strength:
  1. Repetition maximum test (Test 1 RM)
  2. Maximum isometric quadriceps strength and biceps measured with dynamometer (MIE Myometer ltd. with CAS software)
  3. Determination of muscular fatigue in the isometric tests of quadriceps and biceps, with the same system dynamometer (MIE Myometer ltd., software CAS)
  • 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:
  1. Maximum, with cycle ergometer and methodology already known (11), including: Determining, from the respiratory gases, oxygen consumption, carbon production and indirect anaerobic threshold, breathing pattern (minute ventilation, tidal volume, respiratory rate) , electrocardiography and pulse oximetry during exercise with heart rate control, blood pressure and dyspnea Borg scale.
  2. Submaximal cycle ergometer resistance with 80% of the load reached the ultimate test, with essentially control the resistance time, distance walked, and control of saturation (pulse oximetry) and heart rate achieved.
  3. Shuttle walking test, walk test is performed continuously walk between two points separated 10 meters and control the pace of a hearing (12). Assessment of dyspnea and quality of life:
  4. Baseline dyspnea index and index of transitional measures functional impairment, magnitude of the task and the magnitude of effort (Test of Mahler).
  5. Assessment of quality of life based on the specific questionnaire (CRQ) proposed by Guyatt for COPD patients and modified for your understanding in Spanish-speaking subjects.
  6. Study design: The training of the different groups were carried out for 12 weeks, three times per week in sessions of 40 minutes duration.
  7. 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.
  8. 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:
  • Simple bending of the arms (pull cable to the chest "Chest pulls"): Effects on the latissimus dorsi, deltoids and biceps. Sitting in the face of the tower of strength, approaching the bar to the chest and arm span later after return to the starting position.
  • Simple extension arms (force to the neck "Neck presses): Effects on the deltoids and triceps. Sitting upright on the bench and held the weight to shoulder height, arm span will be held over his head, slowly returning after bending arms to starting position.
  • arm flexion and extension against resistance (Mariposa "Butterfly"): Effects on the pectoral and deltoid muscles. Sitting upright on the bench with your forearms and elbows on a lever, takes it to the midline, giving way slowly to the starting position.
  • Extension legs (leg extension): Effects on quadriceps. Sitting on the bench leg extension is performed against resistance.
  • Leg Curl (leg curls): Effects on femoral biceps and calves. Lying prone on the bench legs are flexed against the peso. 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).
  1. 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.
  2. Exit criteria of the study:
  • patient's clinical decompensation
  • Loss of 3 or 5 consecutive sessions staple
  • On the initiative of the patient.
  1. 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.

Being tested
Endurance training, Strength training, Combined training
Keywords
COPD, Exercise Training
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endurance trainingOther

    Also called Respiratory rehabilitation

    compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.

  • Strength trainingOther

    Also called Respiratory Rehabilitation

    compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.

  • Combined trainingOther

    Also called Respiratory Rehabilitation

    compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.

Study groups in NCT01336283
Study groupRoleWhat they receive
COPD with emphysemaActive comparatorAnalyze what type of training is more appropriate and beneficial as the patient characteristics that apply to you.
Receives: Other: Endurance training; Other: Strength training; Other: Combined training
COPD non-emphysemaActive comparatorcompare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Receives: Other: Endurance training; Other: Strength training; Other: Combined training

What is being measured

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

  1. Increase in minute submaximal exercise test

    Check that exercise training increases the tolerance time of submaximal test

    Measured: Parameters will be measured at baseline and end of follow-up period of 12 months

Secondary outcomes (4)
  1. Meters increased 6-minute test after training exercise

    Check that exercise training increases the distance stroll on the walking test

    Measured: Parameters will be measured at baseline and end of follow-up period of 12 months

  2. Kg increase in the 1RM test after training exercise

    Increased peripheral muscle strength (1RM test) after training exercise

    Measured: Parameters will be measured at baseline and end of follow-up period of 12 months

  3. Improvement in dyspnea with a fall of one point in the BDI

    better control of symptoms (BDI test) after exercise training

    Measured: Parameters will be measured at baseline and end of follow-up period of 12 months

  4. Improved quality of life (CRQ) of at least one point (clinically significant) after exercise training

    better quality of life (CRQ) after exercise training

    Measured: Parameters will be measured at baseline and end of follow-up period of 12 months

Timeline

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

  1. First posted15 Apr 2011 (estimated)
  2. Study startMar 2003
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01336283
Sponsor's protocol ID
01/0529
Status last verified
Mar 2003
First submitted
8 Apr 2011
Last updated
15 Apr 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Endurance training, Strength training and Combined training in people with Obstructive Chronic Pulmonary Disease and Emphysema, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.

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 1 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 15 Apr 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 Spain. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Increase in minute submaximal exercise test (time frame: Parameters will be measured at baseline and end of follow-up period of 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Apr 2011.

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