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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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).

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: aerobic exercise + motor skill practice
acute bout of aerobic exercise before motor learning
 Behavioral: aerobic exercise
Single-bout of moderate intensity aerobic exercise on a cycle ergometer 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.
Active Comparator: rest + motor skill practice
seated rest 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT03245216


Locations
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Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b
Erlangen, Germany, 91058
Sponsors and Collaborators
University of Erlangen-Nürnberg
German Foundation for Neurology
Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
Investigators
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Principal Investigator: Simon Steib, Dr. Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Simon Steib, PhD, Dr., University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT03245216    
Other Study ID Numbers: DSN-032017
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
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
aerobic exercise
cardiovascular exercise
 balance
postural instability
motor skill
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