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

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ClinicalTrials.gov Identifier: NCT03245216
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
German Foundation for Neurology
Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
Information provided by (Responsible Party):
Simon Steib, PhD, University of Erlangen-Nürnberg

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 10, 2017
Last Update Posted Date October 24, 2018
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
Motor Learning (Precision) [ 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). ]
Change from baseline in time in balance (±5° from horizontal) during balancing task.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
Motor Learning (Variability) [ 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). ]
Change from baseline in mean standard deviation (root mean square error) of platform deflection (in degree).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facilitating Motor Skill Learning in Parkinson's Disease
Official Title  ICMJE Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Behavioral: aerobic exercise
    Single-bout of moderate intensity aerobic exercise on a cycle ergometer before motor learning
  • Behavioral: rest
    Seated rest before motor learning
  • Behavioral: motor learning
    Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in an horizontal position.
Study Arms  ICMJE
  • Experimental: aerobic exercise + motor skill practice
    acute bout of aerobic exercise before motor learning
    Interventions:
    • Behavioral: aerobic exercise
    • Behavioral: motor learning
  • Active Comparator: rest + motor skill practice
    seated rest before motor learning
    Interventions:
    • Behavioral: rest
    • Behavioral: motor learning
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2018)
28
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2017)
30
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03245216
Other Study ID Numbers  ICMJE DSN-032017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Simon Steib, PhD, University of Erlangen-Nürnberg
Study Sponsor  ICMJE University of Erlangen-Nürnberg
Collaborators  ICMJE
  • German Foundation for Neurology
  • Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
Investigators  ICMJE
Principal Investigator: Simon Steib, Dr. Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport
PRS Account University of Erlangen-Nürnberg
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP