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| Name | Class |
|---|---|
| University of Coimbra | OTHER |
| Hospital Vall d'Hebron | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity: basic physical training (BPT) | Experimental | 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. |
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| Physical activity: BPT combined with functional exercises | Experimental | 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. |
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| Control | Active Comparator | Participants in the control group will maintain their regular daily routines throughout the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxygen consumption rate | Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96 | Beginning of the study and after 4 months |
| Change in ATPmax levels | Maximal mitochondrial ATP production rates measured by Seahorse XFe96 | Beginning of the study and after 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Beginning of the study, first visit |
| Sleepiness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Montane, PhD | Universitat Ramon Llull | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall Hebron Institut de Recerca | Barcelona | Catalonia | 08031 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36551984 | Background | 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. | |
| 31759069 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 5, 2026 | |
| Reset | Jun 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 5, 2026 | Jun 1, 2026 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| usual clinical practice | Other | usual clinical practice |
|
Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire
| Beginning of the study, first visit |
| Mobility | 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 | Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA) | Beginning of the study, first visit |
| Mood | 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 | 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) |
| Sleepiness | Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire | End of the study (4 Months) |
| Mobility | 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 | Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA) | End of the study (4 Months) |
| Mood | Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire | End of the study (4 Months) |
| 37992028 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |