Clinical trial NCT03169270: Muscular Training-induced Changes in COPD
Official title: Muscular Adaptations After Endurance Exercise Training in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Healthy
Keywords: Exercise training
Muscle dysfunction
COPD
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Muscle oxygen saturation (StO2)
timeFrame: Baseline - 8 weeks
measure: Skeletal muscle dysfunction
timeFrame: Baseline - 8 weeks
Secondary outcomes:
measure: Maximal cardiopulmonary response to exercise training
timeFrame: Baseline - 8 weeks
measure: Submaximal cardiopulmonary response to exercise training
timeFrame: Baseline - 8 weeks
measure: Systemic effects of COPD
timeFrame: Baseline - 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Tenyi A, Cano I, Marabita F, Kiani N, Kalko SG, Barreiro E, de Atauri P, Cascante M, Gomez-Cabrero D, Roca J. Network modules uncover mechanisms of skeletal muscle dysfunction in COPD patients. J Transl Med. 2018 Feb 20;16(1):34. doi: 10.1186/s12967-018-1405-y.