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

February 21, 2025 updated by: University Ramon Llull

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08031
        • Vall Hebron Institut de Recerca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity: basic physical training (BPT)

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
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
Other Names:
  • Exercise
Experimental: Physical activity: BPT combined with functional exercises
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
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
Other Names:
  • Exercise
Active Comparator: Control
Participants in the control group will maintain their regular daily routines throughout the study period.
Other: usual clinical practice
usual clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Beginning of the study and after 4 months
Change in ATPmax levels
Time Frame: Beginning of the study and after 4 months
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
Time Frame: Beginning of the study, first visit
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
Mobility
Time Frame: Beginning of the study, first visit
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
Time Frame: Beginning of the study, first visit
Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)
Beginning of the study, first visit
Mood
Time Frame: Beginning of the study, first visit
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
Time Frame: 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
End of the study (4 Months)
Mobility
Time Frame: 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
End of the study (4 Months)
Cognitive aspects
Time Frame: End of the study (4 Months)
Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)
End of the study (4 Months)
Mood
Time Frame: End of the study (4 Months)
Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire
End of the study (4 Months)
Sleepiness
Time Frame: Beginning of the study, first visit
Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire
Beginning of the study, first visit
Sleepiness
Time Frame: End of the study (4 Months)
Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire
End of the study (4 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ramon Llull

Collaborators

University of Coimbra
Hospital Vall d'Hebron

Investigators

  • Principal Investigator: Joel Montane, PhD, Universitat Ramon Llull

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARKEX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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