Department of Human Body Movement, Faculty of Medicine, Universidad Nacional de Colombia, Bogotá Campus, Street 30 No. 45-03 No. 45-03 Building 471, Bogotá, D.C., 110821, Colombia.
Department of Biology, Faculty of Sciences, Universidad Nacional de Colombia, Bogotá Campus, Street 30 No. 45-03, Bogotá, D.C., 110821, Colombia.
Trials. 2023 Oct 29;24(1):698. doi: 10.1186/s13063-023-07698-y.
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.
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.
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.
慢性阻塞性肺疾病（COPD）是一种慢性、非传染性疾病，其特征为低氧血症、肺功能改变、轻微活动时呼吸困难、体力活动耐量受限以及功能障碍。全世界都推荐体育锻炼作为改善 COPD 患者自主性和生活质量的有效策略。然而，目前在高海拔地区生活的人群中，尚未描述他们在暴露于体育锻炼引发的低氧刺激后发生的适应性分子机制。
我们在此提出的临床试验采用准实验设计，进行纵向重复测量分析，包括组内和组间比较，在 4 个时间点测量主要和次要变量。参与者将是居住在高海拔地区（>2600 米）、无肿瘤、肾脏、心脏或肌肉骨骼合并症且体力活动水平低的 COPD 患者。干预措施将是一项为期 8 周的家庭阻力和肌肉力量训练（8-WVP）体育锻炼计划。主要结局变量将是 HIF-1α、VEGF 和 EPO 的表达。作为次要结局变量，我们将考虑肺功能（通过肺活量测定法测量）、身体表现（通过测功计和测力法测量）和血液学参数。
这里提出的临床试验的结果将促进对生活在高海拔地区的 COPD 患者中低氧适应信号蛋白表达的了解，因为目前尚无该人群的数据。应用该方案产生的知识将增加对疾病的病理生理学认识，并为基于体育锻炼处方的未来医学和治疗决策提供依据。
[2A]NCT04955977[ClinicalTrials.gov]-NCT04955977[WHO ICRTP]。首次报告：2021 年 7 月 9 日。
