Clinical trial NCT05963425: The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients with Parkinson's Disease.
Official title: The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients with Parkinson's Disease: a Study Protocol.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Physical Activity
Mitochondrial Function
Skin Fibroblasts
Lead sponsor: University Ramon Llull
Sponsor class: OTHER
Collaborators: name: University of Coimbra
name: Hospital Vall d'Hebron
First posted: 2023-07-27
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in oxygen consumption rate
timeFrame: Beginning of the study and after 4 months
measure: Change in ATPmax levels
timeFrame: Beginning of the study and after 4 months
Secondary outcomes:
measure: Non-motor and motor function
timeFrame: Beginning of the study, first visit
measure: Sleepiness
timeFrame: Beginning of the study, first visit
measure: Mobility
timeFrame: Beginning of the study, first visit
measure: Cognitive aspects
timeFrame: Beginning of the study, first visit
measure: Mood
timeFrame: Beginning of the study, first visit
measure: Non-motor and motor function
timeFrame: End of the study (4 Months)
measure: Sleepiness
timeFrame: End of the study (4 Months)
measure: Mobility
timeFrame: End of the study (4 Months)
measure: Cognitive aspects
timeFrame: End of the study (4 Months)
measure: Mood
timeFrame: End of the study (4 Months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall Hebron Institut de Recerca
state: Catalonia
Study officials:
affiliation: Universitat Ramon Llull
name: Joel Montane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.