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

NCT05963425 | Active Not Recruiting

• 1 other identifier: PARKEX
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Physical Activity; Mitochondrial Function; Skin Fibroblasts

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• Non-motor and motor function

  Beginning of the study, first visit

• Sleepiness

  Beginning of the study, first visit

• Mobility

  Beginning of the study, first visit

• Cognitive aspects

  Beginning of the study, first visit

• Mood

  Beginning of the study, first visit

Study Arms (3)

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.

Other: Physical activity

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.

Other: Physical activity

Control

ACTIVE COMPARATOR

Participants in the control group will maintain their regular daily routines throughout the study period.

Other: usual clinical practice

Interventions

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

Also known as: Exercise

Physical activity: BPT combined with functional exercises; Physical activity: basic physical training (BPT)

usual clinical practice OTHER

usual clinical practice

Control

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ramon Llull: lead
• University of Coimbra: collaborator
• Hospital Vall d'Hebron: collaborator

Study Sites (1)

Vall Hebron Institut de Recerca

Barcelona, Catalonia, 08031, Spain

Location

Related Publications (3)

• 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.

  PMID: 36551984 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.

  PMID: 31759069 BACKGROUND

• 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.

  PMID: 37992028 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joel Montane, PhD

  Universitat Ramon Llull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: April 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)