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

Not Applicable

Active, not recruiting

• Conditions: Parkinson's Disease
• Interventions: Other: Physical activity; Other: usual clinical practice

• Registration Number: NCT05963425
• Lead Sponsor: University Ramon Llull

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.

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Study Start: 2023-09-01
• Primary Completion: 2024-05-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity: BPT combined with functional exercises	Physical activity	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.
Physical activity: basic physical training (BPT)	Physical activity	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.
Control	usual clinical practice	Participants in the control group will maintain their regular daily routines throughout the study period.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vall Hebron Institut de Recerca; 🇪🇸 Barcelona, Catalonia, Spain