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

NCT01336283 | Completed Phase 4

• 1 other identifier: 01/0529
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Chronic Pulmonary Disease; Emphysema

Keywords

COPD; Exercise Training

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Meters increased 6-minute test after training exercise

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

• Kg increase in the 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

  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

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

Study Arms (2)

COPD with emphysema

ACTIVE COMPARATOR

Analyze what type of training is more appropriate and beneficial as the patient characteristics that apply to you.

Other: Endurance training; Other: Strength training; Other: Combined training

COPD non-emphysema

ACTIVE COMPARATOR

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

Other: Endurance training; Other: Strength training; Other: Combined training

Interventions

Endurance training OTHER

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

Also known as: Respiratory rehabilitation

COPD non-emphysema; COPD with emphysema

Strength training OTHER

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

Also known as: Respiratory Rehabilitation

COPD non-emphysema; COPD with emphysema

Combined training OTHER

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

Also known as: Respiratory Rehabilitation

COPD non-emphysema; COPD with emphysema

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, Sevilla, 41013, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Interventions

Endurance Training; Resistance Training

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ortega F Ruiz, Doctor

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 15, 2011
• Study Start: March 1, 2003
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 15, 2011

Record last verified: 2003-03

Locations

ES (1)