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

Parkinson's Disease Clinical Trial

— PARKEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05963425
• Other study ID #: PARKEX
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: University Ramon Llull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Physical activity
This physical activity program will be based only on the work of basic physical traininig, in which specifically and mainly the strength and resistance will be worked, but also flexibility
• usual clinical practice
usual clinical practice

Locations

Country	Name	City	State
Spain	Vall Hebron Institut de Recerca	Barcelona	Catalonia

Sponsors (3)

Lead Sponsor	Collaborator
University Ramon Llull	Hospital Vall d'Hebron, University of Coimbra

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in oxygen consumption rate	Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96	Beginning of the study and after 4 months
Primary	Change in ATPmax levels	Maximal mitochondrial ATP production rates measured by Seahorse XFe96	Beginning of the study and after 4 months
Secondary	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
Secondary	Sleepness	Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire	Beginning of the study, first visit
Secondary	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
Secondary	Cognitive aspects	Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)	Beginning of the study, first visit
Secondary	Mood	Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire	Beginning of the study, first visit
Secondary	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)
Secondary	Sleepness	Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire	End of the study (4 Months)
Secondary	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)
Secondary	Cognitive aspects	Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)	End of the study (4 Months)
Secondary	Mood	Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire	End of the study (4 Months)