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.

Abstract

Parkinson's disease (PD) is characterized by the progressive dopaminergic neuron degeneration, resulting in striatal dopamine deficiency. Mitochondrial dysfunction and oxidative stress are associated with PD pathogenesis. Physical activity (PA) has been shown to ameliorate neurological impairments and to impede age-related neuronal loss. In addition, skin fibroblasts have been identified as surrogate indicators of pathogenic processes correlating with clinical measures. The PARKEX study aims to compare the effects of two different PA programs, analyzing the impact on mitochondrial function in patients' skin fibroblasts as biomarkers for disease status and metabolic improvement. Early-stage PD patients (n = 24, H&Y stage I to III) will be randomized into three age- and sex-matched groups. Group 1 (n = 8) will undergo basic physical training (BPT) emphasizing strength and resistance. Group 2 (n = 8) will undergo BPT combined with functional exercises (BPTFE), targeting the sensorimotor pathways that are most affected in PD (proprioception-balance-coordination) together with cognitive and motor training (Dual task training). Group 3 (n = 8) will serve as control (sedentary group; Sed). Participants will perform three sessions per week for 12 weeks. Assessment of motor function, quality of life, sleep quality, cognitive aspects and humor will be conducted pre- and post-intervention. Patient skin fibroblasts will be collected before and after the intervention and characterized in terms of metabolic remodeling and mitochondrial bioenergetics. Ethical approval has been given to commence this study. This trial is registered at clinicaltrials.gov (NCT05963425). Trial registration. https://classic.clinicaltrials.gov/ct2/history/NCT05963425.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Exercise
  • Exercise Therapy / methods
  • Humans
  • Parkinson Disease*
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Research Design

Associated data

  • ClinicalTrials.gov/NCT05963425

Grants and funding

This work was supported by research funds provided by the Ajuts a l’Activitat de Recerca del Personal Docent i Investigador de la Universitat Ramon Llull (2021-URL-Proj-004 and 2023-URL-Proj-016), the Funding program PGRiD 2019–2021 of the Faculty of Psychology, Education, and Sport Sciences (APR-FPCEE2122/04) and by the European Regional Development Fund (ERDF), through the Centro 2020 Regional Operational Programme under project CENTRO-01-0246-FEDER-000010 (Multidisciplinary Institute of Ageing in Coimbra) through the COMPETE 2020 - Operational Programme for Competitiveness and Internationalisation and Portuguese national funds via FCT - Fundação para a Ciência e a Tecnologia, under projects 2022.01232.PTDC, UIDB/04539/2020, UIDP/04539/2020 and LA/P/0058/2020. S.P.P. was supported by FCT Pos-Doctoral fellowship SFRH/BPD/116061/2016. The authors would also like to acknowledge the support of the Faculty of Psychology, Education, and Sport Sciences, Blanquerna in providing funding for Predoctoral Researchers in Training (PFU) for J.C.M. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.