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

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT01336283
First received: April 8, 2011
Last updated: April 14, 2011
Last verified: March 2003
  Purpose

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.


Condition Intervention Phase
Obstructive Chronic Pulmonary Disease
Emphysema
Other: Endurance training
Other: Strength training
Other: Combined training
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Different Exercise Training Programs to the Profile of COPD Patients

Resource links provided by NLM:


Further study details as provided by Hospitales Universitarios Virgen del Rocío:

Primary Outcome Measures:
  • Increase in minute submaximal exercise test [ Time Frame: Parameters will be measured at baseline and end of follow-up period of 12 months ] [ Designated as safety issue: No ]
    Check that exercise training increases the tolerance time of submaximal test


Secondary Outcome Measures:
  • Meters increased 6-minute test after training exercise [ Time Frame: Parameters will be measured at baseline and end of follow-up period of 12 months ] [ Designated as safety issue: No ]
    Check that exercise training increases the distance stroll on the walking test

  • Kg increase in the 1RM test after training exercise [ Time Frame: Parameters will be measured at baseline and end of follow-up period of 12 months ] [ Designated as safety issue: No ]
    Increased peripheral muscle strength (1RM test) after training exercise

  • Improvement in dyspnea with a fall of one point in the BDI [ Time Frame: Parameters will be measured at baseline and end of follow-up period of 12 months ] [ Designated as safety issue: No ]
    better control of symptoms (BDI test) after exercise training

  • Improved quality of life (CRQ) of at least one point (clinically significant) after exercise training [ Time Frame: Parameters will be measured at baseline and end of follow-up period of 12 months ] [ Designated as safety issue: No ]
    better quality of life (CRQ) after exercise training


Enrollment: 66
Study Start Date: March 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: COPD with emphysema
Analyze what type of training is more appropriate and beneficial as the patient characteristics that apply to you.
Other: Endurance training
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other Name: Respiratory rehabilitation
Other: Strength training
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other Name: Respiratory Rehabilitation
Other: Combined training
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other Name: Respiratory Rehabilitation
Active Comparator: COPD non-emphysema
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other: Endurance training
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other Name: Respiratory rehabilitation
Other: Strength training
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other Name: Respiratory Rehabilitation
Other: Combined training
compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
Other Name: Respiratory Rehabilitation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • other cardiorespiratory diseases.
  • Systemic diseases
  • Inability or discomfort to participate in an exercise program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336283

Locations
Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Ortega F Ruiz, Doctor Hospitales Universitarios Virgen del Rocío
  More Information

No publications provided

Responsible Party: Francisco Ortega Ruiz, Neumología Hospital Virgen del Rocio
ClinicalTrials.gov Identifier: NCT01336283     History of Changes
Other Study ID Numbers: 01/0529
Study First Received: April 8, 2011
Last Updated: April 14, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospitales Universitarios Virgen del Rocío:
COPD
Exercise Training

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014