Muscular Training-induced Changes in COPD

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Healthy
• Interventions: Other: Exercise training

• Registration Number: NCT03169270
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

The current protocol is developed in the context of a large Research and Innovation (R\&I) program aiming the promotion of daily life physical activity in chronic patients registered at clinicaltrials.gov (NCT02976064) and approved by the ethical committee of the Hospital Clinic de Barcelona (HCB/2016/0883). The project is partly supported by the Smart Innovation Strategies promoted by the EU Commission (COMRDI15-1-0016). Specifically, the protocol uses retrospective information collected between 2005-2008 as part of the EU project Biobridge (LSHG-CT-2006-037939).

The aims of the current analysis of the retrospective information are 1) to assess training-induced changes in muscle oxygen saturation (StO2) assessed by near-infrared spectroscopy (NIRS) during constant-work rate cycling exercise (CWRE) as a useful marker of the effects of training at limb muscle level in patients with chronic obstructive pulmonary disease (COPD), and 2) to further explore underlying mechanisms of skeletal muscle dysfunction as a characteristic systemic effect of COPD, potentially modifiable with preventive interventions as endurance muscle training.

Methods: Incremental exercise (VO2 peak) and CWRE at 70% baseline peak work rate, before and after 8-week of endurance exercise training, were done in healthy sedentary subjects and COPD patients. NIRS was used to assess StO2 in the left "vastus internus" during the CWRE (before an after training program) (objective 1); and blood samples and muscle biopsies of the quadriceps were obtained at rest (before an after training program) (objective 2).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2017-05
• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-25
• Last Update Submitted: 2017-05-25
• Study First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• COPD diagnosis following GOLD criteria (FEV1/FVC post-broncodilator <0,7)
• Clinical stability for at least 3 months

Exclusion Criteria

• Age <45 years
• Any active cancer
• Comorbidities which carry high-level of handicap
• Other respiratory disease than COPD
• No sign of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy training group	Exercise training	Healthy sedentary age-matched subjects were recruited from the outpatients' clinics of our hospital. The intervention consists in an 8-week programe of exercise training.
COPD training group	Exercise training	COPD were required to be clinically stable at the time of study without episodes of exacerbation or oral steroid treatment in the previous four months. All COPD patients were on bronchodilators and inhaled corticosteroids. No patient presented severe co-morbidities. The intervention consists in an 8-week programe of exercise training.

Primary Outcome Measures

Name	Time	Method
Muscle oxygen saturation (StO2)	Baseline - 8 weeks	Near-infrared spectroscopy (NIRS)
Skeletal muscle dysfunction	Baseline - 8 weeks	Quadriceps muscle biopsies

Secondary Outcome Measures

Name	Time	Method
Systemic effects of COPD	Baseline - 8 weeks	Blood sample
Maximal cardiopulmonary response to exercise training	Baseline - 8 weeks	Incremental exercise test
Submaximal cardiopulmonary response to exercise training	Baseline - 8 weeks	Constant work rate exercise test (CWRE)