Strength-Endurance Circuit Training in Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGeneral University Hospital, Prague

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥18 years

diagnosis of idiopathic Parkinson´s disease

Hoehn-Yahr Scale ≤ 2,5

stable dopaminergic medication

Disqualifiers

age ≥75 years

Hoehn-Yahr Scale ≥ 2,5

deep brain stimulation

presence of freezing

Trial design

Design model

Parallel

Treatments tested in this trial

  • Strength-Endurance Training

    Other intervention

    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 intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Combined Strength-Endurance Circuit TrainingExperimental treatment 1 intervention
Group B: Endurance Circuit TrainingActive comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
2

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.

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

Other outcomes

Sponsors and contacts

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