Strength-Endurance Circuit Training in Parkinson's Disease

Strength-Endurance Circuit Training in Parkinson's Disease: Effects on Disease Severity, Physical Performance, Blood Biomarkers and Quality of Life.

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

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease, Idiopathic
• Intervention / Treatment: Other: Endurance Training; Other: Strength-Endurance Training

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakub Vítek, MSc.; Phone Number: +420 224 965 513; Email: jakub.vitek@vfn.cz

Study Locations

• Czech Republic
  • Prague, Czech Republic, 12000
    • Recruiting
    • Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague
    • Contact: Jakub Vítek, MSc.; Phone Number: +420 224 965 513; Email: jakub.vitek@vfn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Combined Strength-Endurance Circuit Training	Other: Strength-Endurance Training; The intervention for the experimental Strength-Endurance group includes warm-up, three laps of strength and endurance exercises and cool-down. The training program lasts 3 months and includes two 1-hour training sessions per week, for a total of 24 sessions.
Active Comparator: Endurance Circuit Training	Other: Endurance Training; The intervention for the control Endurance training group includes warm-up, three laps of endurance exercises and cool-down. The training program lasts 3 months and includes two 1-hour training sessions per week, for a total of 24 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. and III.	The maximum total UPDRS score is 272, indicating the worst possible disability from PD. The minimum total score is 0, indicating no disability from PD. Improvement greater than (-4.9) points or worsening more than (+4.2) points on MDS-UPDRS II+III represent a minimal clinically important difference.	From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of steps		Average number of steps in the period before training (6 months), during the training period (3 months), period after training (3 months).
One Repetition Maximum (1RM)	One Repetition Maximum in strength training is the maximum weight that can be lifted once while maintaining the correct lifting technique. It will be measured using a leg press machine for the lower extremities and a dumbbell chest press for the upper extremities.	From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Timed Up and Go Test (TUG)	Mean TUG score for Non-falling PD patients on medication is 7.94 (2.15) seconds. MCID is 3.5 seconds.	From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Blood irisin levels		From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Cardiopulmonary Exercise Testing		From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
The Parkinson's Disease Questionnaire (PDQ-39)	The minimum score is 0, while the maximum score is 100. A higher score indicates a lower QoL.	From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Blood brain-derived neurotrophic factor levels		From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Blood cytokine levels		From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)

Collaborators and Investigators

• Sponsor: General University Hospital, Prague

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Parkinson Disease; Physiotherapy; Irisin; Endurance training; Strength training; Physical performance
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 56125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data (IPD), including the study protocol, statistical analysis plan, informed consent form, and clinical study report, will be made available upon reasonable request to qualified researchers, but will not be publicly accessible.
• IPD Sharing Access Criteria: IPD will be shared with all qualified researchers upon reasonable request sent to a contact email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No