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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Strength-Endurance Circuit Training | Experimental |
| |
| Endurance Circuit Training | Active Comparator |
| |
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakub VĂtek, MSc. | Contact | +420 224 965 513 | jakub.vitek@vfn.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague | Recruiting | Prague | Prague | 12000 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23536417 | Background | 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. | |
| 36044549 | Background |
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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.
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IPD will be shared with all qualified researchers upon reasonable request sent to a contact email.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000076663 | Endurance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| 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. |
|
| 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) |
| 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). |
|
| 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. |
| 38134742 | 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. |
| 34997759 | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |