Chronic obstructive pulmonary disease COPD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: articipants diagnosed with severe COPD (FEV1 <50% of predicted; quartiles 3 and 4 in the BODE [Body-mass index, airflow Obstruction, Dyspnea, and Exercise] index) will be recruited. All participants will obtain medical permission from a pulmonary medical specialist (MD) before taking part in the study
Exclusion criteria
Exclusion criteria: It will be current insulin therapy, long-term oxygen therapy, asthma, other concomitant pulmonary diseases, or other diseases that could affect physical activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All participants will be evaluated in four testing days (T1-T4) before and after the 12-week training using blinded evaluators. After the medical screening (T0), a familiarization to the testing procedure will be carried out to prevent inaccuracy of pre-training measured due to other factors (e.g., confidence, insufficient practice, or learning effect). Testing day 1 Blood samples: Resting venous blood samples will be collected following 12-h overnight fast using a needle and Vacutainer kit. Blood samples from the antecubital vein will be collected in two EDTA and two serum vacutainer tubes (10 ml) and will be centrifuged for 10 min at 5,000 rpm. Plasma and serum obtained will be aliquoted for 500 uL and stored at -80° C. Part of Plasma samples will be delivered to a local clinical laboratory for glucose and insulin concentrations, lipid profile (triacylglycerols, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) and C-reactive protein determination. Homeostasis model assessment (HOMA) will be calculated as a surrogate measure of insulin resistance. From the stored aliquots, inflammatory markers (IL-6, IL-1ß, and TNF-alpha) and plasma microRNAs will be analyzed in our laboratory. Functional performance: the timed up-and-go test will be performed to assess functional performance in addition to the 6MWT explained above. In brief, patients will be given verbal instructions to stand up from a chair, walk three meters as quickly and as safely as possible, turn around, walk back, and sit down. The test will be repeated three times, and the best performance will be used for analyses. Testing day 2 Quality of life and general wellbeing: The St. George´s Respiratory Questionnaire for COPD patients (SGRQ-C) Spanish version will be used to measure the participant’s functional health and wellbeing as in previous studies. It contains 50 items divided into three subscales: symptoms (8 items), including several respiratory symptoms, thei | — |
Secondary
| Measure | Time frame |
|---|---|
| The molecular adaptations in the skeletal muscle after training will be assessed from muscle biopsies from the vastus lateralis before and after training. Muscle biopsies will be taken 48 h after T3 before and after training. Participants: 10 patients per group will undertake muscle biopsies (n=30). This sample size was estimated using data from previous studies in which muscle fiber type MRF (i.e., myostatin, MyoD) and phosphorylation of p70S6K40, increased after training interventions (i.e., aerobic and resistance training). Thus, based on effect sizes ranging from 1 to 2.5 from those studies, and an a level of 0.05 and a power (1-ß) of 0.8, it was found that 8 patients per group would be sufficient. To account for a possible 30% dropout, we will recruit 10 patients per group in this study. Muscle biopsies will not be performed on individuals on anti-platelet or anti-coagulation therapy. Testing day 4 Muscle biopsy: Patients will attend the Laboratory at 8:00 a.m. after overnight fasting without having carried out any type of exercise in the previous 48 hours. An ultrasound imaging assessment of VL thickness and guidance will be used to reinsure biopsy site and patient safety. Briefly, after local anesthesia with 1.5 mL of lidocaine 2%, a 1-cm skin incision will be performed, and muscle samples will be obtained on the vastus lateralis of the non-dominant leg (mid-thigh; 15 cm above the patella) by an experienced medical doctor using the modified Bergstrom needle technique with suction following suggested procedures in similar population.104 Excellent safety and sample quality have been demonstrated with Bergström percutaneous muscle biopsy technique, with comparable diagnostic yield compared to open biopsy methods.105 Muscle samples will be separated from any fatty tissue and blood, and divided into portions that will be treated for specific analyses. Muscle samples (~80 mg specimen) will be divided into 5 parts for: 1) fiber type isolation (20 mg), 2) microRNAs | — |
Countries
Chile
Contacts
Universidad Andrés Bello