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

University Ramon Llull

Status: Active, not recruiting

Conditions: Parkinson's Disease

Treatments: Other: Physical activity; Other: usual clinical practice

Study type: Interventional

Funder types: Other

Identifiers

NCT05963425

PARKEX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Physical activity: basic physical training (BPT)

Experimental group

Description:

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.

Treatment:

Other: Physical activity

Physical activity: BPT combined with functional exercises

Experimental group

Description:

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.

Treatment:

Other: Physical activity

Control

Active Comparator group

Description:

Participants in the control group will maintain their regular daily routines throughout the study period.

Treatment:

Other: usual clinical practice