Effects of a physical exercise program on HIF-1α in people with Chronic Obstructive Pulmonary Disease living at high altitude: study protocol for a clinical trial.

Background: Chronic Obstructive Pulmonary Disease (COPD) is a chronic, noncommunicable disease characterized by hypoxemia, with altered lung function, dyspnea on mild exertion, limited tolerance to physical exertion, and functional impairment. Physical exercise has been recommended worldwide as an efficient strategy to improve the autonomy and quality of life of patients affected by COPD. However, the adaptive molecular mechanisms occurring in these patients after the exposure to the hypoxic stimulus triggered by physical exercise have currently not been described in populations living at high altitude.

Methods: The clinical trial we are presenting here consists of a quasi-experimental design with longitudinal analysis of repeated measures, with intra- and inter-group comparisons, measuring primary and secondary variables in 4 temporal points. Participants will be people with a diagnosis of COPD residing at high altitudes (> 2600 m), without oncological, renal, cardiac, or musculoskeletal comorbidities with a low level of physical activity. The intervention will be an 8-week program of physical exercise of resistance and muscular strength (8-WVP) which will be carried out at home. Primary outcome variables will be the expression of HIF-1α, VEGF, and EPO. As secondary outcome variables, we will consider lung function (measured by spirometry), physical performance (measured by ergospirometry and dynamometry), and hematological parameters.

Discussion: The results obtained after the clinical trial proposed here will promote knowledge on the expression of signaling proteins as an adaptive response to hypoxia in people with COPD living at high altitude, which will be relevant because there are not data on this population group. The knowledge generated from the application of this protocol will increase the pathophysiological understanding of the disease and future medical and therapeutic decision-making based on physical exercise prescription. TRIAL REGISTRATION {2A}: NCT04955977 [ClinicalTrials.gov]-NCT04955977 [WHO ICRTP]. First Posted: July 9, 2021.