Clinical trial NCT06893055: Strength-Endurance Circuit Training in Parkinson's Disease
Official title: Strength-Endurance Circuit Training in Parkinson's Disease: Effects on Disease Severity, Physical Performance, Blood Biomarkers and Quality of Life.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease, Idiopathic
Keywords: Parkinson Disease
Strength training
Endurance training
Physiotherapy
Irisin
Quality of Life
Physical performance
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine whether adding strength training to aerobic training has a comparable or greater effect on the clinical status of Parkinson's disease patients than a standalone aerobic training.

- Does combined strength-endurance circuit training provide added benefits to physical performance, disease severity, blood biomarkers, and quality of life in PD patients compared to standalone aerobic training?

Participants will:

* undergo outcome measurements before and after the 12-week intervention and a 3-month follow-up measurement,
* visit the clinic twice a week for 1-hour training sessions.
* selected patients will be given a smartwatch with a pedometer that will count their average number of steps before, during and after the training period


Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* diagnosis of idiopathic Parkinson´s disease
* Hoehn-Yahr Scale ≤ 2,5
* stable dopaminergic medication

Exclusion Criteria:

* age ≥75 years
* Hoehn-Yahr Scale ≥ 2,5
* deep brain stimulation
* presence of freezing
* Camptocormia
* inability to walk without support
* inability to perform study procedures
* limiting co-morbidities
* attendance at training sessions below 70%

Primary outcomes:
measure: Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. and III.
timeFrame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Secondary outcomes:
measure: One Repetition Maximum (1RM)
timeFrame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
measure: Timed Up and Go Test (TUG)
timeFrame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
measure: Blood irisin levels
timeFrame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
measure: Cardiopulmonary Exercise Testing
timeFrame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
measure: The Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
measure: Blood brain-derived neurotrophic factor levels
timeFrame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
measure: Blood cytokine levels
timeFrame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
measure: Average number of steps
timeFrame: Average number of steps in the period before training (6 months), during the training period (3 months), period after training (3 months).
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague
Study officials:
References:
citation: Corcos DM, Robichaud JA, David FJ, Leurgans SE, Vaillancourt DE, Poon C, Rafferty MR, Kohrt WM, Comella CL. A two-year randomized controlled trial of progressive resistance exercise for Parkinson's disease. Mov Disord. 2013 Aug;28(9):1230-40. doi: 10.1002/mds.25380. Epub 2013 Mar 27.
citation: Kam TI, Park H, Chou SC, Van Vranken JG, Mittenbuhler MJ, Kim H, A M, Choi YR, Biswas D, Wang J, Shin Y, Loder A, Karuppagounder SS, Wrann CD, Dawson VL, Spiegelman BM, Dawson TM. Amelioration of pathologic alpha-synuclein-induced Parkinson's disease by irisin. Proc Natl Acad Sci U S A. 2022 Sep 6;119(36):e2204835119. doi: 10.1073/pnas.2204835119. Epub 2022 Aug 31.
citation: Shi X, Gu Q, Fu C, Ma J, Li D, Zheng J, Chen S, She Z, Qi X, Li X, Wu S, Wang L. Relationship of irisin with disease severity and dopamine uptake in Parkinson's disease patients. Neuroimage Clin. 2024;41:103555. doi: 10.1016/j.nicl.2023.103555. Epub 2023 Dec 15.
citation: Gamborg M, Hvid LG, Dalgas U, Langeskov-Christensen M. Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. Acta Neurol Scand. 2022 May;145(5):504-528. doi: 10.1111/ane.13579. Epub 2022 Jan 8.