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

• ClinicalTrials.gov Identifier: NCT03245216
• Recruitment Status: Completed
• First Posted: August 10, 2017
• Last Update Posted: October 24, 2018
• Sponsor: University of Erlangen-Nürnberg
• 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

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

• Principal Investigator: Simon Steib, Dr.; Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport

More Information

Additional Information:

project webpage 

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

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.

• 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
• Last Update Posted: October 24, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases