Facilitating Motor Skill Learning in Parkinson's Disease (FAST-PD)
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, aerobic exercise, cardiovascular exercise, balance, postural instability, motor skill
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
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-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aerobic exercise + motor skill practice
rest + motor skill practice
Arm Description
acute bout of aerobic exercise before motor learning
seated rest before motor learning
Outcomes
Primary Outcome Measures
Motor Learning (Precision)
Change from baseline in time in balance (±5° from horizontal) during balancing task.
Secondary Outcome Measures
Motor Learning (Variability)
Change from baseline in mean standard deviation (root mean square error) of platform deflection (in degree).
Full Information
NCT ID
NCT03245216
First Posted
July 31, 2017
Last Updated
October 23, 2018
Sponsor
University of Erlangen-Nürnberg
Collaborators
German Foundation for Neurology, Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
1. Study Identification
Unique Protocol Identification Number
NCT03245216
Brief Title
Facilitating Motor Skill Learning in Parkinson's Disease
Acronym
FAST-PD
Official Title
Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
September 30, 2018 (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
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 aerobic exercise on motor learning in Parkinson patients. Specifically, the investigators examine whether a single bout of moderate intensity aerobic exercise, performed immediately before task practice, facilitates the acquisition and retention of a motor skill. In a cross-over design, participants will be randomly allocated to either the intervention group (aerobic exercise before motor learning) or control group (rest before motor learning).
Detailed Description
Parkinson's disease 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 is consequently considered to be a motor learning process. While motor learning is preserved in persons with Parkinson's disease, slower acquisition rates and reduced retention have been reported compared to healthy individuals.
Thus, it is crucial to identify strategies to enhance motor learning in people with Parkinson's disease. Recent studies have accumulated evidence to show that aerobic exercise can facilitate motor skill learning. However, these observations are limited to healthy individuals and have not been addressed in individuals with neurologic conditions.
The present study is designed to assess the effects of a single bout of moderate intensity aerobic exercise on a motor skill learning task in patients with Parkinson's disease.
In a cross-over design, participants will be randomly allocated to one of two groups. Both groups will practice balancing on a specific stability platform (motor learning task). The experimental group will additionally perform a bout of aerobic exercise (cycle ergometer) immediately before the motor learning task, while the control group will rest before practice. Subsequently, the acquisition and one-day retention of the motor learning task will be examined.
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, aerobic exercise, cardiovascular exercise, balance, postural instability, motor skill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aerobic exercise + motor skill practice
Arm Type
Experimental
Arm Description
acute bout of aerobic exercise before motor learning
Arm Title
rest + motor skill practice
Arm Type
Active Comparator
Arm Description
seated rest before motor learning
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
Single-bout of moderate intensity aerobic exercise on a cycle ergometer before motor learning
Intervention Type
Behavioral
Intervention Name(s)
rest
Intervention Description
Seated rest before motor learning
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 an horizontal position.
Primary Outcome Measure Information:
Title
Motor Learning (Precision)
Description
Change from baseline in time in balance (±5° from horizontal) during balancing task.
Time Frame
Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).
Secondary Outcome Measure Information:
Title
Motor Learning (Variability)
Description
Change from baseline in mean standard deviation (root mean square error) of platform deflection (in degree).
Time Frame
Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).
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
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-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b
City
Erlangen
ZIP/Postal Code
91058
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30405397
Citation
Steib S, Wanner P, Adler W, Winkler J, Klucken J, Pfeifer K. A Single Bout of Aerobic Exercise Improves Motor Skill Consolidation in Parkinson's Disease. Front Aging Neurosci. 2018 Oct 22;10:328. doi: 10.3389/fnagi.2018.00328. eCollection 2018.
Results Reference
derived
Links:
URL
https://www.sport.fau.de/lehrstuehle-und-fachgebiete/bewegung-und-gesundheit/forschungsprojekte/optimierung-motorischer-lernprozesse-in-der-rehabilitation-von-parkinsonpatienten/
Description
project webpage
Learn more about this trial
Facilitating Motor Skill Learning in Parkinson's Disease
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