Parkinson Disease, IdiopathicNCT06893055
Strength-Endurance Circuit Training in Parkinson's Disease
A study testing Strength-Endurance Training and Endurance Training in people with Parkinson Disease, Idiopathic, run by General University Hospital, Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease, Idiopathic
- What is being tested?
- Strength-Endurance Training and Endurance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Mar 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- diagnosis of idiopathic Parkinson´s disease
- Hoehn-Yahr Scale ≤ 2,5
- stable dopaminergic medication
Who cannot join
- age ≥75 years
- Hoehn-Yahr Scale ≥ 2,5
- deep brain stimulation
- presence of freezing
- Camptocormia
- inability to walk without support
Show all 9Show fewer
- inability to perform study procedures
- limiting co-morbidities
- attendance at training sessions below 70%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague
Prague, Prague, 12000
Jakub Vítek, MSc., +420 224 965 513, jakub.vitek@vfn.cz
About this study
Official title: 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?
Read more
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
- Being tested
- Strength-Endurance Training, Endurance Training
- Keywords
- Parkinson Disease, Strength training, Endurance training, Physiotherapy, Irisin, Quality of Life, Physical performance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength-Endurance TrainingOther
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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Strength-Endurance Circuit Training | Experimental | Not described Receives: Other: Strength-Endurance Training |
| Endurance Circuit Training | Active comparator | Not described Receives: Other: Endurance Training |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Blood irisin levels
Measured: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Cardiopulmonary Exercise Testing
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Blood cytokine levels
Measured: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Average number of steps
Measured: Average number of steps in the period before training (6 months), during the training period (3 months), period after training (3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start3 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Vítek, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893055
- Sponsor's protocol ID
- 56125
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 23536417Kam 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.
PubMed 36044549Shi 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.
PubMed 38134742Gamborg 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.
PubMed 34997759
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength-Endurance Circuit Training in Parkinson's Disease: Effects on Disease Severity, Physical Performance, Blood Biomarkers and Quality of Life.
- ClinicalTrials.gov ID
- NCT06893055
- Acronym / sponsor ID
- 56125
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- Parkinson Disease, Strength training, Endurance training, Physiotherapy, Irisin, Quality of Life, Physical performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined Strength-Endurance Circuit Training | Experimental | Other: Strength-Endurance Training |
| Endurance Circuit Training | Active comparator | Other: Endurance Training |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18 years
- diagnosis of idiopathic Parkinson´s disease
- Hoehn-Yahr Scale ≤ 2,5
- stable dopaminergic medication
Key exclusion criteria (9 listed)
- age ≥75 years
- Hoehn-Yahr Scale ≥ 2,5
- deep brain stimulation
- presence of freezing
- Camptocormia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength-Endurance TrainingThe 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. | Other | Combined Strength-Endurance Circuit Training |
| Endurance TrainingThe 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. | Other | Endurance Circuit Training |
Primary outcome
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. and III.
Time frame: 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.
8 secondary outcomes
One Repetition Maximum (1RM)
Time frame: 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)
Time frame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Blood irisin levels
Time frame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Cardiopulmonary Exercise Testing
Time frame: 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)
Time frame: 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
Time frame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Blood cytokine levels
Time frame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
Average number of steps
Time frame: Average number of steps in the period before training (6 months), during the training period (3 months), period after training (3 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 23536417Corcos 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.
- Background: PubMed 36044549Kam 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.
- Background: PubMed 38134742Shi 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.
- Background: PubMed 34997759Gamborg 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength-Endurance Training and Endurance Training in people with Parkinson Disease, Idiopathic, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakub Vítek, MSc. (+420 224 965 513, jakub.vitek@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. and III. (time frame: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06893055, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.