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NCT Number: NCT06893055

Strength-Endurance Circuit Training in Parkinson's Disease

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

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Key information

Conditions

Parkinson Disease, Idiopathic Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Prague, 12000, Czechia

Location status: Recruiting

Location contact

Jakub Vítek, MSc.

CONTACT

[email protected]

+420 224 965 513

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    Mean TUG score for Non-falling PD patients on medication is 7.94 (2.15) seconds. MCID is 3.5 seconds.

  3. 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)

  4. 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)

  5. 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)

    The minimum score is 0, while the maximum score is 100. A higher score indicates a lower QoL.

  6. 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)

  7. 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)

  8. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jakub Vítek, MSc.

CONTACT

[email protected]

+420 224 965 513

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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