Effects of Exercise Training on Systemic Inflammation an Muscle Repair According to the Obstructive Chronic Pulmonary Disease (COPD) Phenotype

NCT01431625 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-09-09

No results posted yet for this study

Summary

AIM: To identify those mechanisms involved in the systemic and muscular response to exercise treatment, in two different Obstructive Chronic Pulmonary Disease (COPD) phenotypes (emphysema and non-emphysema). The investigators will evaluate the effect of exercise training, on exercise outcomes, peripheral muscle strength measures, dyspnea and quality of life indices, and markers of systemic inflammation and muscle repair.

SUBJECTS: The investigators will study 30 COPD patients in GOLD II-IV stages, with symptomatic disease. Patients will be differentiated into 2 different phenotypes: predominant-emphysema and non-predominant emphysema (15 subjects for each group), according to high resolution computed tomography (HRCT) scanning images, and after the specific analysis with the MeVisPulmo software. After patients are typified, they will be included in the 12- wk training programme. MEASURES(pre\&post-training):Basic blood analysis, EKG, spirometry, blood gases, pletysmography, gas diffusion, maximal inspiratory and expiratory pressure (MIP,MEP), bioimpedanciometry, 1RM test and isometric strength determination, 6-min walking test (6MWT), maximal and submaximal cycle-ergometry, and dyspnea using the Mahler's Basal and Transitional Dyspnoea Indexes (BDI/TDI) and quality of life (Chronic Respiratory Disease Questionnaire \[(CRDQ\]) evaluation. Besides, the investigators will measure blood PCR and cytokines levels (IL6, IL8, IL10, IL12, TNF-α, IGF-1, and MIC-A \& MIC-B). Muscle biopsies will be made (quadriceps) for detection of TNF-α, TNFR-I, TNFR-II, IGF-1Ea and MGF, IGF-1R, genes bound to biogenesis, markers of cell lesion-stress and myosin heavy chains (MyHC) type I and II, N-CAM/CD56 and Met \& Desmin

Conditions

  • Obstructive Chronic Pulmonary Disease
  • Emphysema
  • Chronic Bronchitis

Interventions

OTHER

Combined Training (endurance and strength exercises)

All patients underwent a training program to be held for 12 weeks in sessions of 60 minutes: 1. .- 20 minutes of bicycle ergometer with an initial load level of about 70% of baseline peak oxygen consumption, increasing the load every two weeks as tolerated. 2. \- Weightlifting in 2 sets of 6 reps of 5 simple exercises. These are held at a station multigimnastyc (CLASSIC Fitness Center, KETTLER) and are as follows: "pulls Chest," "Shoulder press," "Butterfly," "Leg extension" and "Leg curls." The resistance will be increased gradually from 70% of the maximum weight you can lift the patient in a single maneuver (Test 1RM). Every two weeks the maximum weight is re-evaluated to adjust the training load in each patient.

Sponsors & Collaborators

  • Fondo de Investigacion Sanitaria

    collaborator OTHER
  • Hospitales Universitarios Virgen del Rocío

    lead OTHER

Principal Investigators

  • Ortega F Ruiz, Doctor · Hospitales Universitarios Virgen del Rocío

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431625 on ClinicalTrials.gov