The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients With Parkinson's Disease.

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients With Parkinson's Disease: a Study Protocol.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Physical activity
* Other: usual clinical practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity: basic physical training (BPT)<br>Exercises will target the large muscle groups, with a component/emphasis on the eccentric phase of concentration. The kBox4 Platform (Exxentric AB), a device designed to maximize performance and training outcomes, will be used to enhance the eccentric phase of the exercises. kBox4 is controlled by a specific program, Kmeter, which records and stores all the information (duration, intensity, repetitions, etc.) of each movement. Exxentric kBox4 will be adapted with special harnesses, insurances on the wall and in front of support bars, according to the needs of the patients. In addition to the major muscle groups, specific attention will be given to the key muscles involved in the gait cycle, such as the tibialis anterior, medial gastrocnemius, rectus femoris, and hamstrings, from a biomechanical perspective. | Other: Physical activity<br>* This physical activity program will be based only on the work of basic physical traininig, in which specifically and mainly the strength and resistance will be worked, but also flexibility<br>* Other names: Exercise;|
| Experimental: Physical activity: BPT combined with functional exercises<br>In addition to the BPT program (which includes the transverse focus on strength and resistance exercises), this intervention group will incorporate functional exercises that involve dual task training. The dual task training can encompass both motor-motor and motor-cognitive activities. This means that coordinated exercises will be performed, with cognitive activities introduced at the extremes of the movement. This approach ensures engagement of both physical and cognitive abilities during the PA sessions. | Other: Physical activity<br>* This physical activity program will be based only on the work of basic physical traininig, in which specifically and mainly the strength and resistance will be worked, but also flexibility<br>* Other names: Exercise;|
| Active Comparator: Control<br>Participants in the control group will maintain their regular daily routines throughout the study period. | Other: usual clinical practice<br>* usual clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxygen consumption rate | Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96 | Beginning of the study and after 4 months | 
| Change in ATPmax levels | Maximal mitochondrial ATP production rates measured by Seahorse XFe96 | Beginning of the study and after 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-motor and motor function | non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire | Beginning of the study, first visit | 
| Sleepness | Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire | Beginning of the study, first visit | 
| Mobility | clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire | Beginning of the study, first visit | 
| Cognitive aspects | Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA) | Beginning of the study, first visit | 
| Mood | Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire | Beginning of the study, first visit | 
| Non-motor and motor function | non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire | End of the study (4 Months) | 
| Sleepness | Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire | End of the study (4 Months) | 
| Mobility | clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire | End of the study (4 Months) | 
| Cognitive aspects | Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA) | End of the study (4 Months) | 
| Mood | Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire | End of the study (4 Months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Physical Activity, Mitochondrial Function, Skin Fibroblasts