Facilitating Motor Skill Learning in Parkinson's Disease II (FaST-PD II) (FaST-PD II)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
aerobic exercise
rest
motor learning
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, motor learning, neuroplasticity, aerobic exercise, cardiovascular exercise, balance, postural instability, motor memory, consolidation
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease stage 1-3 on Hoehn & Yahr scale
- Ability to stand unaided and walk without an assistive device
- Stable medication during the study period
- Unfamiliar to the motor learning task
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
Sites / Locations
- Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport, Gebbertstr. 123b
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
motor skill practice + aerobic exercise
motor skill practice + rest
Arm Description
acute bout of aerobic exercise following motor skill practice
seated rest following motor skill practice
Outcomes
Primary Outcome Measures
Time in balance
Motor memory consolidation: Change of time in balance (angular displacement ±5° from horizontal) from skill practice (last block of skill acquisition) to 24-hour and seven-day retention test.
Secondary Outcome Measures
Root mean square error (RMSE)
Memory consolidation: Change of root mean square error (average angular deviation from horizontal) from skill practice (last block of skill acquisition) to one-day and seven-day retention test.
Full Information
NCT ID
NCT03886090
First Posted
March 20, 2019
Last Updated
March 23, 2020
Sponsor
University of Erlangen-Nürnberg
Collaborators
German Foundation for Neurology, Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg, Klinik für Neurologie, Krankenhaus Rummelsberg
1. Study Identification
Unique Protocol Identification Number
NCT03886090
Brief Title
Facilitating Motor Skill Learning in Parkinson's Disease II (FaST-PD II)
Acronym
FaST-PD II
Official Title
Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease II
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg
Collaborators
German Foundation for Neurology, Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg, Klinik für Neurologie, Krankenhaus Rummelsberg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 a single bout of moderate-intense aerobic exercise, performed immediately following motor skill practice, 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).
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) cardiovascular exercise can facilitate motor skill learning. However, this evidence is mainly derived from studying healthy individuals. In a first study including PD patients, we recently found improved motor memory consolidation, but not skill acquisition, when practice was preceded by a single bout of cardiovascular exercise.
These results suggest that acute exercise may enhance motor memory formation processes, but could potentially interfere with motor skill acquisition when performed prior to practice. Consequently, the present study investigates whether performing a single bout of cardiovascular exercise immediately following skill practice will enhance motor memory consolidation without affecting skill acquisition in PD.
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. Subsequently, motor skill retention will be tested after 24 hour and seven-days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, motor learning, neuroplasticity, aerobic exercise, cardiovascular exercise, balance, postural instability, motor memory, consolidation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
motor skill practice + aerobic exercise
Arm Type
Experimental
Arm Description
acute bout of aerobic exercise following motor skill practice
Arm Title
motor skill practice + rest
Arm Type
Active Comparator
Arm Description
seated rest following motor skill practice
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
Single-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice
Intervention Type
Behavioral
Intervention Name(s)
rest
Intervention Description
Seated rest following motor skill practice
Intervention Type
Behavioral
Intervention Name(s)
motor learning
Intervention Description
Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in a horizontal position.
Primary Outcome Measure Information:
Title
Time in balance
Description
Motor memory consolidation: Change of time in balance (angular displacement ±5° from horizontal) from skill practice (last block of skill acquisition) to 24-hour and seven-day retention test.
Time Frame
Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
Secondary Outcome Measure Information:
Title
Root mean square error (RMSE)
Description
Memory consolidation: Change of root mean square error (average angular deviation from horizontal) from skill practice (last block of skill acquisition) to one-day and seven-day retention test.
Time Frame
Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease stage 1-3 on Hoehn & Yahr scale
Ability to stand unaided and walk without an assistive device
Stable medication during the study period
Unfamiliar to the motor learning task
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Steib, Dr.
Organizational Affiliation
Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport, Gebbertstr. 123b
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91058
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.sport.fau.de/lehrstuehle-und-fachgebiete/bewegung-und-gesundheit/forschungsprojekte/optimierung-motorischer-lernprozesse-in-der-rehabilitation-von-parkinsonpatienten/
Description
project website
Learn more about this trial
Facilitating Motor Skill Learning in Parkinson's Disease II (FaST-PD II)
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