Strength-Endurance Circuit Training in Parkinson's Disease

NCT06893055 | Recruiting

• 1 other identifier: 56125
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease, Idiopathic

Keywords

Parkinson Disease; Strength training; Endurance training; Physiotherapy; Irisin; Quality of Life; Physical performance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• One Repetition Maximum (1RM)

  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)

  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)

  From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)

Study Arms (3)

Combined Strength-Endurance Circuit Training

EXPERIMENTAL

Other: Strength-Endurance Training

Endurance Circuit Training

ACTIVE COMPARATOR

Other: Endurance Training

Control Group

NO INTERVENTION

Interventions

Strength-Endurance Training OTHER

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.

Combined Strength-Endurance Circuit Training

Endurance Training OTHER

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.

Endurance Circuit Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague

Prague, Prague, 12000, Czechia

RECRUITING

Related Publications (4)

• 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.

  PMID: 23536417 BACKGROUND

• 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.

  PMID: 36044549 BACKGROUND

• 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.

  PMID: 38134742 BACKGROUND

• 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.

  PMID: 34997759 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jakub Vítek, MSc.

CONTACT

+420 224 965 513; jakub.vitek@vfn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD will be shared with all qualified researchers upon reasonable request sent to a contact email.

Locations

CZ (1)