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Parkinson's DiseasePARKEXNCT05963425

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

A study testing Physical activity and usual clinical practice in people with Parkinson's Disease, run by University Ramon Llull at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Physical activity and usual clinical practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSpain
Study dates
1 Sep 2023to Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • Vall Hebron Institut de Recerca

    Barcelona, Catalonia, 08031

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Physical activity, usual clinical practice
Keywords
Parkinson's Disease, Physical Activity, Mitochondrial Function, Skin Fibroblasts
Medical subject headings
Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activityOther

    Also called Exercise

    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 practiceOther

    usual clinical practice

Study groups in NCT05963425
Study groupRoleWhat they receive
Physical activity: basic physical training (BPT)ExperimentalExercises 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.
Receives: Other: Physical activity
Physical activity: BPT combined with functional exercisesExperimentalIn 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.
Receives: Other: Physical activity
ControlActive comparatorParticipants in the control group will maintain their regular daily routines throughout the study period.
Receives: Other: usual clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in oxygen consumption rate

    Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96

    Measured: Beginning of the study and after 4 months

  2. Change in ATPmax levels

    Maximal mitochondrial ATP production rates measured by Seahorse XFe96

    Measured: Beginning of the study and after 4 months

Secondary outcomes (10)

  1. Non-motor and motor function

    non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire

    Measured: Beginning of the study, first visit

  2. Sleepiness

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

    Measured: Beginning of the study, first visit

  3. Mobility

    clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire

    Measured: Beginning of the study, first visit

  4. Cognitive aspects

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

    Measured: Beginning of the study, first visit

  5. Mood

    Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire

    Measured: Beginning of the study, first visit

  6. Non-motor and motor function

    non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire

    Measured: End of the study (4 Months)

  7. Sleepiness

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

    Measured: End of the study (4 Months)

  8. Mobility

    clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire

    Measured: End of the study (4 Months)

  9. Cognitive aspects

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

    Measured: End of the study (4 Months)

  10. Mood

    Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire

    Measured: End of the study (4 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start1 Sep 2023
  3. Primary completion31 May 2024
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05963425
Sponsor's protocol ID
PARKEX
Acronym
PARKEX
Status last verified
Jan 2025
First submitted
12 Jul 2023
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Magana JC, Deus CM, Gine-Garriga M, Montane J, Pereira SP. Exercise-Boosted Mitochondrial Remodeling in Parkinson's Disease. Biomedicines. 2022 Dec 12;10(12):3228. doi: 10.3390/biomedicines10123228.

    PubMed 36551984

  • Deus CM, Pereira SP, Cunha-Oliveira T, Pereira FB, Raimundo N, Oliveira PJ. Mitochondrial remodeling in human skin fibroblasts from sporadic male Parkinson's disease patients uncovers metabolic and mitochondrial bioenergetic defects. Biochim Biophys Acta Mol Basis Dis. 2020 Mar 1;1866(3):165615. doi: 10.1016/j.bbadis.2019.165615. Epub 2019 Nov 20.

    PubMed 31759069

  • Magana JC, Enriquez-Calzada S, Prat R, Deus CM, Pereira SP, Avellanet M, Gea E, Laguna A, Martinez-Vicente M, Perez-Larumbe O, Gine-Garriga M, Hernandez-Vara J, Montane J. Effects of basic and dual-task training programs on physical function in Parkinson's disease: The PARKEX study. PLoS One. 2026 Sep 18;21(9):e0358534. doi: 10.1371/journal.pone.0358534. eCollection 2026.

    PubMed 42758697

  • Magana JC, Deus CM, Baldellou L, Avellanet M, Gea-Rodriguez E, Enriquez-Calzada S, Laguna A, Martinez-Vicente M, Hernandez-Vara J, Gine-Garriga M, Pereira SP, Montane J. Investigating the impact of physical activity on mitochondrial function in Parkinson's disease (PARKEX): Study protocol for A randomized controlled clinical trial. PLoS One. 2023 Nov 22;18(11):e0293774. doi: 10.1371/journal.pone.0293774. eCollection 2023.

    PubMed 37992028

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity and usual clinical practice in people with Parkinson's Disease, run by University Ramon Llull at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in oxygen consumption rate (time frame: Beginning of the study and after 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05963425, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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