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

NCT01431625 | Unknown Phase 4 DMC

• 1 other identifier: 02/0529
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COPD; Exercise Training

Outcome Measures

Primary Outcomes (1)

• Change from baseline in TNF-alpha and its receptors, muscle isoforms of IGF-1 and its receptor in samples of quadriceps muscle satellite cells at 3 moths.

  Compare these values according to the phenotype of the patient (airway-predominant vs. emphysema-predominant) and assess the effect of the training program, according to the phenotype, the regenerative potential and muscle remodeling.

  Baseline and end of follow-up period of 3 moths

Secondary Outcomes (3)

• Pax7, M-cadherin and Myo-D and its receptor in samples (molecules and repair-myogenesis) of quadriceps muscle satellite cells.

  Baseline and end of follow-up period of 3 moths

• MIC-A and MIC-B soluble in serum.

  Baseline and end of follow-up period of 3 moths.

• CRP, IL6, IL8, IL10, IL12, TNF alpha, IGF-1 (systemic inflammatory profile) in serum.

  Baseline and end of follow-up period of 3 moths.

Study Arms (2)

COPD with emphysema-predominant

ACTIVE COMPARATOR

The degree of involvement of the lung parenchyma and the airway are assessed by computed tomography. The HRCT is performed using 2-mm collimation, scan time 1.0 s, 120 kVp, and 200 mA. Images at three different levels (a cranial section is obtained 1 cm above the superior margin of the aortic arch, a middle section is taken at 1 cm below the carina, and a caudal section is taken approximately 3 cm above the top of the diaphragm) are selected and LAA% is then automatically calculated. The identification threshold of normal lung density and LAA is set at -960 HU. The cut-off level between high or low LAA% is the mean + 2SD of LAA% of the asymptomatic non-COPD smokers.

Other: Combined Training (endurance and strength exercises)

COPD with airway-predominant

ACTIVE COMPARATOR

The degree of involvement of the lung parenchyma and the airway are assessed by computed tomography. The HRCT is performed using 2-mm collimation, scan time 1.0 s, 120 kVp, and 200 mA. Images at three different levels (a cranial section is obtained 1 cm above the superior margin of the aortic arch, a middle section is taken at 1 cm below the carina, and a caudal section is taken approximately 3 cm above the top of the diaphragm) are selected and LAA% is then automatically calculated. The helical scan is performed using 120 kVp, 50 mA, 3-mm collimation, and pith 1.0. The dimensions of the right apical segmental bronchus are measured and WA% is calculated. The cut-off level between high or low WA% is the mean + 2SD of WA% of the asymptomatic non-COPD smokers.

Other: Combined Training (endurance and strength exercises)

Interventions

Combined Training (endurance and strength exercises) OTHER

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.

Also known as: Respiratory Rehabilitation

COPD with airway-predominant; COPD with emphysema-predominant

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients diagnosed according to criteria established by the ATS (American Thoracic Society) and the SEPAR (Spanish Society of Pneumology and Thoracic Surgery) obstruction presenting moderate to severe airway obstruction (FEV1 \<60%) and a clinical impact of their disease. Patients should be stable and appropriate therapy, and must not have suffered exacerbations of the disease over a period of three months before the study, and without treatment with oral corticosteroids for at least the same period.

You may not qualify if:

• Other cardio-respiratory diseases, cardiovascular, neuromuscular or metabolic might interfere with the results.
• Systemic diseases, alcohol intake (\> 80 g / day) or treatment with drugs with potential effect on muscle structure
• Inability or disagree 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 Rocío

Seville, Sevilla, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ortega F Ruiz, Doctor

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ortega F Ruiz, Doctor

CONTACT

955013172; med000521@saludalia.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Section of Pneumology

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 9, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 9, 2011

Record last verified: 2011-09

Locations

ES (1)