Exploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease
NCT ID: NCT06580977
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-02-27
2027-07-31
Brief Summary
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Detailed Description
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In a randomized controlled trial, 60 persons with mild to moderate PD (i.e., Hoehn \& Yahr ≤3) will either perform moderate-intensity cardiovascular training (experimental group) or stretching (control group) for twelve weeks (three times per week, totaling 36 training sessions; duration per training session 30 to 55 min). Participants will perform a procedural memory task before and after the intervention to analyze the effects on non-declarative memory formation (primary outcome). In addition, secondary and exploratory analyses will include the assessment of episodic memory formation, cognitive function, cardiorespiratory fitness, sleep quality, and BDNF blood concentration levels. The findings of the present study contribute to the current discussion on the neuroplastic effects of cardiovascular training and may have important implications for neurorehabilitation in pwPD.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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cardiovascular training
The experimental group will perform a cardiovascular training three times a week over 12 weeks.
cardiovascular training
Cardiovascular training will be performed in supervised sessions and in small groups of 2-5 persons at the study site. The training is performed on a cycle ergometer at 60% of peak power output (Wmax) for 30 min (i.e., 5 min warm-up, 20 min at 60% Wmax, 5 min cool-down) three times a week for twelve weeks. The exercise program will be increased by 5 min (max. 55 min) and 5% of intensity (in Watt) every two weeks. If participants report a too low (i.e., Borg scale ≤ 11) or too high (i.e., Borg scale ≥ 16) subjective rate of perceived exertion (RPE; Borg scale 6-20) intensity will be increased or decreased until the target levels are met (i.e., Borg scale 12-15). During training, heart rate, intensity (in Watt) and RPE will be monitored. Participants missing training sessions will be offered an additional week to perform up to three training sessions.
stretching
The active control group will perform a stretching training three times a week over 12 weeks.
stretching
The stretching training will be performed in supervised sessions and in small groups of 2-5 persons at the study site. Stretching training consists of lying, seated, and standing flexibility exercises (according to the recommendations of the American Parkinson´s Disease Foundation and the Parkinson Society Canada) for 30 min (i.e., 5 min warm-up, 20 min main part, 5 min cool-down) three times a week for twelve weeks. The exercise program will be increased by 5 min (i.e., adding additional repetitions and exercises; max. 55 min) every two weeks. Intensity of stretching exercises will be assessed by subjective rate of perceived muscle tension on a visual analog scale (VAS) from 0 to 10 and will be moderate defined as 5 to 7 on the VAS. During training VAS, heart rate, and RPE will be monitored. Participants missing training sessions will be offered an additional week to perform up to three training sessions.
Interventions
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cardiovascular training
Cardiovascular training will be performed in supervised sessions and in small groups of 2-5 persons at the study site. The training is performed on a cycle ergometer at 60% of peak power output (Wmax) for 30 min (i.e., 5 min warm-up, 20 min at 60% Wmax, 5 min cool-down) three times a week for twelve weeks. The exercise program will be increased by 5 min (max. 55 min) and 5% of intensity (in Watt) every two weeks. If participants report a too low (i.e., Borg scale ≤ 11) or too high (i.e., Borg scale ≥ 16) subjective rate of perceived exertion (RPE; Borg scale 6-20) intensity will be increased or decreased until the target levels are met (i.e., Borg scale 12-15). During training, heart rate, intensity (in Watt) and RPE will be monitored. Participants missing training sessions will be offered an additional week to perform up to three training sessions.
stretching
The stretching training will be performed in supervised sessions and in small groups of 2-5 persons at the study site. Stretching training consists of lying, seated, and standing flexibility exercises (according to the recommendations of the American Parkinson´s Disease Foundation and the Parkinson Society Canada) for 30 min (i.e., 5 min warm-up, 20 min main part, 5 min cool-down) three times a week for twelve weeks. The exercise program will be increased by 5 min (i.e., adding additional repetitions and exercises; max. 55 min) every two weeks. Intensity of stretching exercises will be assessed by subjective rate of perceived muscle tension on a visual analog scale (VAS) from 0 to 10 and will be moderate defined as 5 to 7 on the VAS. During training VAS, heart rate, and RPE will be monitored. Participants missing training sessions will be offered an additional week to perform up to three training sessions.
Eligibility Criteria
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Inclusion Criteria
* Disease stage ≤3 on the Hoehn \& Yahr scale
* Age ranging from 50 - 80 years
* Naive to the memory tasks (primary outcomes)
* Ability to stand and walk at least 10 meters independently
Exclusion Criteria
* Significant level of cognitive impairment (i.e., Montreal Cognitive Assessment \<21)
* Deep brain stimulation or brain pacemaker
* Diagnosed psychiatric illness
* Known clinically relevant neurological, internal or orthopedic conditions besides Parkinsonism that would interfere with the exercise paradigm
* Exceeding the recommended level of cardiovascular exercise for older adults (i.e., cardiovascular exercise done ≥150 min per week of moderate-intensity or ≥75 min per week of vigorous-intensity)
50 Years
80 Years
ALL
No
Sponsors
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German Foundation for Neurology
OTHER
University Hospital Heidelberg
OTHER
Universitätsmedizin Mannheim
OTHER
SRH Kurpfalzkrankenhaus Heidelberg
UNKNOWN
Heidelberg University
OTHER
Responsible Party
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Simon Steib
Prof. Dr.
Principal Investigators
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Simon Steib, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Philipp Wanner, Dr.
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Locations
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Heidelberg University
Heidelberg, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Simon Steib, Prof. Dr.
Role: primary
Philipp Wanner, Dr.
Role: backup
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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EMCo
Identifier Type: -
Identifier Source: org_study_id