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Facilitating Motor Skill Learning in Parkinson's Disease III (FaST-PD-III)

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ClinicalTrials.gov Identifier: NCT04653285
Recruitment Status : Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : October 20, 2021
Sponsor:
Collaborators:
German Foundation for Neurology
Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital
Information provided by (Responsible Party):
Simon Steib, PhD, University of Erlangen-Nürnberg

Study Description
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Brief Summary:
The study is designed to assess the effects of cardiovascular (aerobic) exercise on motor skill learning in Parkinson patients. Specifically, the investigators examine whether moderate-intense aerobic exercise, performed immediately following motor skill practice over the course of a six week intervention period, facilitates motor memory consolidation. In this experimental trial, participants will be randomly allocated to either an intervention group (motor skill practice + aerobic exercise) or control group (motor skill practice + seated rest).

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: motor skill practice Behavioral: aerobic exercise Behavioral: rest Not Applicable

Detailed Description:

Parkinson's disease (PD) is a progressive neurodegenerative disorder that is characterized by motor control impairments, such as gait disturbances and postural instability. Beneficial effects of exercise are attributed to mechanisms of neuroplasticity, and task-specific motor training (repeated practice of a skill) is consequently considered to be a motor learning process. Importantly, the formation (acquisition) and consolidation of motor memories is impaired in PD compared to healthy individuals of similar age.

Thus, it is crucial to identify strategies to enhance motor learning in people with PD. Recent studies have accumulated evidence to show that acute (single bouts of) and chronic (multiple bouts of) cardiovascular exercise can facilitate motor skill learning. However, this evidence is mainly derived from studying healthy individuals. In a first study including PD patients, the investigators recently found improved motor memory consolidation, but not improved skill acquisition, when practice was preceded by a single bout of cardiovascular exercise.

These results suggested that acute exercise may enhance motor memory formation processes, but could potentially interfere with motor skill acquisition when performed prior to practice. Consequently, in a second study the investigators examined whether performing a single bout of cardiovascular exercise immediately following skill practice would enhance motor memory consolidation without affecting skill acquisition in PD. The results of this second study suggested that even a single moderate intense bout performed immediately following skill practice improves motor memory consolidation in PD patients.

Going onward from the previous two studies, the present study will investigate the effects of performing cardiovascular exercise immediately following skill practice over the course of a six week intervention period on motor memory consolidation. It will be examined how the regular direct coupling of motor learning skill practice and cardiovascular exercise influences the consolidation and automation of the practiced movements.

In an experimental trial, participants will be randomly allocated to one of two groups. Both groups will practice balancing on a stability platform (motor learning task). The experimental group will additionally perform a bout of aerobic exercise (cycle ergometer) immediately following motor practice, while the control group will rest. This intervention will be held over a period of six weeks. Subsequently, motor skill retention will be tested seven days after the last training session.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease III
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: motor skill practice + aerobic exercise
bout of aerobic exercise following motor skill practice
 Behavioral: motor skill practice
Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.

Behavioral: aerobic exercise
A bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice.
Active Comparator: motor skill practice + rest
seated rest following motor skill practice
 Behavioral: motor skill practice
Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.

Behavioral: rest
Seated rest following motor skill practice.


Outcome Measures
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Primary Outcome Measures :
  1. Time in balance [ Time Frame: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance ]
    Motor memory consolidation: Change of time in balance (angular displacement ±5° from horizontal) over the course of all six skill practice sessions and the seven day retention test.


Secondary Outcome Measures :
  1. Root mean square error (RMSE) [ Time Frame: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance ]
    Memory consolidation: Change of root mean square error (average angular deviation from horizontal) over the course of all six skill practice sessions and the seven day retention test.

  2. Dual-Task-Performance: Counting Backwards [ Time Frame: Week 1: performance at baseline; Week 8: performance at seven day retention ]
    Motor memory automatization: Change of time in balance (angular displacement ±5° from horizontal) in addition to error score of a backwards-counting-task from Pre- to Post-Assessment

  3. Transfer Test Performance: Fullerton Advanced Balance Scale (FAB - Scale) [ Time Frame: Week 1: performance at baseline; Week 8: performance at seven day retention ]
    Transfer Effects of Balance: Change of the achieved score on the FAB - Scale from Pre- to Post- Assessment; minimum value: 0; maximum value: 40; higher scores indicate better outcome

  4. Muscular Endurance: Five Times Sit to Stand Test [ Time Frame: Week 1: performance at baseline; Week 8: performance at seven day retention ]
    Strength Endurance: Change of time necessary to rise five times from a chair

  5. BDNF - Levels (Brain-derived neurotrophic factor) [ Time Frame: Week 1: BDNF concentration at baseline; Week 2 a + b: BDNF concentration before (a) and after (b) Intervention; Session: 7 a + b: BDNF concentration before (a) and after (b) Intervention; Week 8: BDNF concentration at seven day retention ]
    Change of BDNF - Concentration in Blood samples

  6. VO2 max Level [ Time Frame: Week 1: VO2max at baseline; Week 8: VO2max at seven day retention ]
    Maximum oxygen uptake and overall effect on cardiovascular fitness level: submaximal stress test on bicycle ergometer

  7. Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Score [ Time Frame: Week 1: score at baseline; Week 8: score at seven day retention ]
    Parkinson Disease Rating Score (motor section): Change of UPDRS Score; minimum value: 0; maximum value: 132; higher scores indicate worse outcome

  8. Montreal Cognitive Assessment Score (MoCA - Score) [ Time Frame: Week 1: score at baseline; Week 8: score at seven day retention ]
    Cognitive capability: Montreal Cognitive Assessment Score; minimum value: 0; maximum value: 30; higher scores indicate better outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease stage 1-3,5 on Hoehn & Yahr scale
  • Ability to stand unaided and walk without an assistive device
  • Stable medication during the study period
  • Unfamiliar to the motor task (stabilometer)

Exclusion Criteria:

  • On-off and wearing-off phenomena
  • Unstable medical or psychiatric illness
  • Clinically relevant cardiovascular or orthopaedic disease
  • Severe polyneuropathy
  • Cognitive impairment
  • Smoking > 10 cigarettes/day
  • Caffeine > 6 cups of coffee/day
  • Alcohol > 50 g (two glasses)/day
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653285


Contacts
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Contact: Simon Steib, Dr. 0049 91318528178 simon.steib@tum.de
Contact: Florian Ostermair, MSc 0049 91318528106 florian.ostermair@fau.de

Locations
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Germany
Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport, Gebbertstr. 123b
Erlangen, Bavaria, Germany, 91058
Contact: Simon Steib, Dr.    0049 91318528178    simon.steib@tum.de   
Contact: Florian Ostermair, MSc    0049 91318528106    florian.ostermair@fau.de   
Principal Investigator: Simon Steib, Dr.         
Sub-Investigator: Wanner Philipp, MSc         
Sub-Investigator: Ostermair Florian, MSc         
Sponsors and Collaborators
University of Erlangen-Nürnberg
German Foundation for Neurology
Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital
Investigators
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Principal Investigator: Simon Steib, Dr. Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport
  Study Documents (Full-Text)

Documents provided by Simon Steib, PhD, University of Erlangen-Nürnberg:
Study Protocol and Statistical Analysis Plan  [PDF] December 2, 2020

More Information
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Additional Information:

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Responsible Party: Simon Steib, PhD, Principal Investigator, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT04653285    
Other Study ID Numbers: DSN-2020
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Steib, PhD, University of Erlangen-Nürnberg:
Parkinson's Disease
motor learning
neuroplasticity
aerobic exercise
cardiovascular exercise
 balance
postural instability
motor memory
consolidation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases