Strength-Endurance Circuit Training in Parkinson's Disease: Effects on Disease Severity, Physical Performance, Blood Biomarkers and Quality of Life.
| Registry | NCT06893055 |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 90 (Estimated) |
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| Sponsor | General University Hospital, Prague (Other) |
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| Conditions | Parkinson Disease, Idiopathic |
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| Interventions | Strength-Endurance Training, Endurance Training (Other) |
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| Dates | start 2025-03-03, primary completion 2026-12-01 (estimated), completion 2027-03-01 (estimated), first posted 2025-03-25, last updated 2025-04-09 |
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| Locations | 1 site in Czechia |
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Related Papers Related Patents Related Grants Related Experts
All trials for Parkinson Disease, Idiopathic All trials of Strength-Endurance Training All trials of Endurance Training
-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
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Combined Strength-Endurance Circuit Training | Experimental | Other: Strength-Endurance Training | |
| Endurance Circuit Training | Active comparator | Other: Endurance Training | |
| Control Group | No intervention | | |
- 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.
- 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.
+Outcome measures
Primary outcomes
- Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. and III. [From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]: 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.
Secondary outcomes
- One Repetition Maximum (1RM) [From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]: 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.
- 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)]: Mean TUG score for Non-falling PD patients on medication is 7.94 (2.15) seconds. MCID is 3.5 seconds.
- 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)]: The minimum score is 0, while the maximum score is 100. A higher score indicates a lower QoL.
- 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)]
- 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).]
+Eligibility
Sex: All, ages: 18 Years to 75 Years
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%
+Locations (1)
| Facility | City | Country | Status |
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| Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague | Prague, Prague | Czechia | Recruiting |
+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. PMID 23536417
- 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
- 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
- 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