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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05963425
Acronym
PARKEX
Enrollment
24
Registered
2023-07-27
Start date
2023-09-01
Completion date
2026-04-30
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease, Physical Activity, Mitochondrial Function, Skin Fibroblasts

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.

Interventions

OTHERPhysical activity

This physical activity program will be based only on the work of basic physical training, in which specifically and mainly the strength and resistance will be worked, but also flexibility

usual clinical practice

Sponsors

University of Coimbra
CollaboratorOTHER
Hospital Vall d'Hebron
CollaboratorOTHER
University Ramon Llull
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in oxygen consumption rateBeginning of the study and after 4 monthsOxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96
Change in ATPmax levelsBeginning of the study and after 4 monthsMaximal mitochondrial ATP production rates measured by Seahorse XFe96

Secondary

MeasureTime frameDescription
MobilityBeginning of the study, first visitclinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire
Non-motor and motor functionBeginning of the study, first visitnon-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire
MoodBeginning of the study, first visitIntensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire
Cognitive aspectsBeginning of the study, first visitCognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)
SleepinessBeginning of the study, first visitSelf-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026