The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients with Parkinson's Disease: a Study Protocol.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- University Ramon Llull
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in oxygen consumption rate
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in oxygen consumption rate
Time Frame: Beginning of the study and after 4 months
Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96
Change in ATPmax levels
Time Frame: Beginning of the study and after 4 months
Maximal mitochondrial ATP production rates measured by Seahorse XFe96
Secondary Outcomes
- 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))