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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hospitales Universitarios Virgen del Rocío.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Francisco Ortega Ruiz, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT01431625
First received: September 6, 2011
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Obstructive Chronic Pulmonary Disease
Emphysema
Chronic Bronchitis
Other: Combined Training (endurance and strength exercises)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Exercise Training on Systemic Inflammation an Muscle Repair According to the Chronic Obstructive Pulmonary Disease Phenotype

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline and end of follow-up period of 3 moths ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pax7, M-cadherin and Myo-D and its receptor in samples (molecules and repair-myogenesis) of quadriceps muscle satellite cells. [ Time Frame: Baseline and end of follow-up period of 3 moths ] [ Designated as safety issue: No ]
    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.

  • MIC-A and MIC-B soluble in serum. [ Time Frame: Baseline and end of follow-up period of 3 moths. ] [ Designated as safety issue: No ]
    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. Determine whether the presence of these substances impact in terms of exercise capacity, nutritional status and muscle function.

  • CRP, IL6, IL8, IL10, IL12, TNF alpha, IGF-1 (systemic inflammatory profile) in serum. [ Time Frame: Baseline and end of follow-up period of 3 moths. ] [ Designated as safety issue: No ]
    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. Determine whether the presence of these substances impact in terms of exercise capacity, nutritional status and muscle function.


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: COPD with emphysema-predominant
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)

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.
Other Name: Respiratory Rehabilitation
Active Comparator: COPD with airway-predominant
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)

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.
Other Name: Respiratory Rehabilitation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT01431625

Contacts
Contact: Ortega F Ruiz, Doctor 955013172 med000521@saludalia.com

Locations
Spain
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Contact: Marquez E Marquez, Doctor    656486927    eduardomarquezmartin@hotmail.com   
Contact: Valencia B Azcona, Doctor    669102839    borja_valencia_azcona@hotmail.com   
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, Head of Section of Pneumology, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT01431625     History of Changes
Other Study ID Numbers: 02/0529
Study First Received: September 6, 2011
Last Updated: September 8, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Lung Diseases
Inflammation
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 18, 2014