Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Epigenetic factors influencing muscle metabolism
研究概览
简要总结
Pulmonary Arterial Hypertension has gone from a disease that causes rapid death to a more chronic condition. Yet, improved survival is associated with major challenges for clinicians as most patients remain with poor quality of life and limited exercise capacity. The effects of exercise training on exercise capacity have been largely evaluated and showed an improvement in 6-minutes walking distance (6MWD), peak V'O2. It is also known that exercise program improves quality of life. Maximal volitional and nonvolitional strength of the quadriceps are reduced in patients with Pulmonary Arterial Hypertension and correlated to exercise capacity. Moreover, on the cellular level, alterations are observed in both the respiratory as well as the peripheral muscles. Muscle fiber size has been reported to be decreased in some studies or conversely unaltered in human and animal models. Reduction in type I fibers and a more anaerobic energy metabolism has also been reported, but not in all studies. Likewise, a loss in capillary density in quadriceps of patients with Pulmonary Arterial Hypertension and rats has been reported, but could not be confirmed in other studies. While the impact of exercise training on clinical outcomes such as exercise capacity or quality of life is well known, this data highlight the fact that the underlying causes of peripheral muscle weakness as well as the mechanisms underlying the clinical improvements observed with exercise programs are not completely understood. Improvement of muscle cell metabolism in part via the enhancement of oxidative cellular metabolism and decrease in intracellular lipid accumulation may play a role in improving muscle function and exercise capacity.
In this study, we intend to evaluate the impact of a 12 weeks home-based rehabilitation program on peripheral muscle function and metabolism, focusing on lipid infiltration, oxidative metabolism and epigenetic factors that can be involved in metabolic syndrome, in patients with Pulmonary Arterial Hypertension.
详细描述
The 12 weeks home-based rehabilitation program is detailed as follows:
- 1st sessions at the hospital, in the presence of a physiotherapist/kinesiologist
- 3 weeks of supervised home-based rehabilitation (using a telemonitoring system) 3 times a weeks
- 9 weeks of unsupervised home-based rehabilitation (one phone call a week)
Patients will be evaluated at baseline and at endpoint (12 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women > 18 years old
- •Pulmonary Arterial Hypertension group 1: idiopathic, genetics, drug or toxin-induced, associated with connective tissue, HIV, portal hypertension, congenital heart disease.
- •Diagnosis performed by right heart catheterization with Pulmonary Arterial Pressure⩾ 20 mmHg, pulmonary artery occlusion pressure <15 and pulmonary vascular resistance >3 Wood units
- •New York Heart Association II or III and a 6-Minute Walk Test < 500m
- •Patient stable without therapeutic modification within the last 3 months
- •Patient having wireless internet at home
- •Consciously informed and written by the patient
排除标准
- •Syncope within the last 6 month
- •Metabolic comorbidity (eg Diabetes)
- •Musculoskeletal impairment that does not allow physical exercise
- •Patient unable or with contraindications to perform a cardio pulmonary exercise testing
- •Patient with pulmonary veno-occlusive disease
- •Presence of a permanent pacemaker or other contraindication to MRI
- •Pregnant or breastfeeding woman
- •Age <18 years
结局指标
主要结局
Epigenetic factors influencing muscle metabolism
时间窗: Changes between baseline and 12 weeks of exercise rehabilitation
Transcriptome analysis using RNA-seq
次要结局
- HbA1c(Changes between baseline and 12 weeks of exercise rehabilitation)
- Intramyocellular lipid accumulation(Changes between baseline and 12 weeks of exercise rehabilitation)
- Proportion of muscle fiber types(Changes between baseline and 12 weeks of exercise rehabilitation)
- Muscular mitochondrial phosphorylation (ATP synthesis)(Changes between baseline and 12 weeks of exercise rehabilitation)
- Insulin(Changes between baseline and 12 weeks of exercise rehabilitation)
- Glucose(Changes between baseline and 12 weeks of exercise rehabilitation)
- Non-volitional strength of the quadriceps(Changes between baseline and 12 weeks of exercise rehabilitation)
- Apolipoprotein A1(Changes between baseline and 12 weeks of exercise rehabilitation)
- Adiponectin(Changes between baseline and 12 weeks of exercise rehabilitation)
- Volitional strength quadriceps(Changes between baseline and 12 weeks of exercise rehabilitation)
- Functional Exercise capacity(Changes between baseline and 12 weeks of exercise rehabilitation)
- Leptin(Changes between baseline and 12 weeks of exercise rehabilitation)
- Maximal exercise capacity(Changes between baseline and 12 weeks of exercise rehabilitation)
- Quality of life (QOL)(Changes between baseline and 12 weeks of exercise rehabilitation)
研究者
Marius Lebret
Post-doctoral fellow
Laval University