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NCT Number: NCT05963425

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall Hebron Institut de Recerca

Barcelona, Catalonia, 08031, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Other

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

usual clinical practice

Other

usual clinical practice

Primary outcomes

  1. 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

  2. Change in ATPmax levels

    Time frame: Beginning of the study and after 4 months

    Maximal mitochondrial ATP production rates measured by Seahorse XFe96

Secondary outcomes

  1. 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

  2. Sleepiness

    Time frame: Beginning of the study, first visit

    Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire

  3. 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

  4. Cognitive aspects

    Time frame: Beginning of the study, first visit

    Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)

  5. 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

  6. 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

  7. Sleepiness

    Time frame: End of the study (4 Months)

    Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire

  8. 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

  9. Cognitive aspects

    Time frame: End of the study (4 Months)

    Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)

  10. 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

Sponsors and collaborators

Lead sponsor

University Ramon Llull

Other

Collaborators

  • Hospital Vall d'Hebron
  • University of Coimbra

Registry information

Official study title

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

Acronym: PARKEX

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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