The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients with Parkinson's Disease: a Study Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in oxygen consumption rate
研究概览
简要总结
The aim of this study is to investigate the effect of physical activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease.
详细描述
A randomized double-blind clinical trial will be conducted to study the effects of physical activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease. It is an intervention study, and twenty-four patients will be needed. Once the subjects have been selected, they will be randomly assigned into three groups (eight patients in each group). The first group will perform basic physical training (BPT) based on strength and resistance, the second group will perform BPT combined with functional exercises (BPTFE) with cognitive and motor training, and the third group will not carry out any activity program, serving as control. The interventions will last 60 minutes, with a frequency of 3 times a week, during 16 weeks. The control group will receive 4 months of PA from the program that has obtained the best results,in terms of symptoms and quality of life, after the last evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a medical diagnosis of idiopathic PD, Hoehn and Yahr scale stages of I-III.
- •Patients who score ≥26 on the Montreal Cognitive Assessment (MoCA).
- •Patients who have signed the IC.
- •Patients with stable medication.
- •Age between 50 and 70 years, and able to walk independently for 6 minutes.
排除标准
- •Patients with a pathology other than idiopathic PD.
- •Patients with cognitive impairment (MoCA <26 points).
- •Patients with uncontrolled cardiovascular disease, visual impairment, or recent musculoskeletal disorders in the extremities.
- •Patients who are performing another therapeutic exercise protocol.
- •Patients who have undergone surgery to influence any symptom from the PD.
结局指标
主要结局
Change in oxygen consumption rate
时间窗: Beginning of the study and after 4 months
Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96
Change in ATPmax levels
时间窗: Beginning of the study and after 4 months
Maximal mitochondrial ATP production rates measured by Seahorse XFe96
次要结局
- Non-motor and motor function(End of the study (4 Months))
- Sleepiness(End of the study (4 Months))
- Mobility(End of the study (4 Months))
- Cognitive aspects(End of the study (4 Months))
- Mood(End of the study (4 Months))