We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03886090
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
German Foundation for Neurology
Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
Klinik für Neurologie, Krankenhaus Rummelsberg
Information provided by (Responsible Party):
Simon Steib, PhD, University of Erlangen-Nürnberg

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

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

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease II
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : February 24, 2020
Actual Study Completion Date : February 24, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: motor skill practice + aerobic exercise
acute bout of aerobic exercise following motor skill practice
 Behavioral: aerobic exercise
Single-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice

Behavioral: motor learning
Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in a horizontal position.
Active Comparator: motor skill practice + rest
seated rest following motor skill practice
 Behavioral: rest
Seated rest following motor skill practice

Behavioral: motor learning
Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in a horizontal position.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time in balance [ 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 ]
    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 :
  1. Root mean square error (RMSE) [ 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 ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03886090


Locations
Layout table for location information
Germany
Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport, Gebbertstr. 123b
Erlangen, Bavaria, Germany, 91058
Sponsors and Collaborators
University of Erlangen-Nürnberg
German Foundation for Neurology
Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
Klinik für Neurologie, Krankenhaus Rummelsberg
Investigators
Layout table for investigator information
Principal Investigator: Simon Steib, Dr. Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport
  Study Documents (Full-Text)

Documents provided by Simon Steib, PhD, University of Erlangen-Nürnberg:
Study Protocol and Statistical Analysis Plan  [PDF] March 19, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Simon Steib, PhD, Principal Investigator, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT03886090    
Other Study ID Numbers: DSN-2018
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
neuroplasticity
aerobic exercise
cardiovascular exercise
 balance
postural instability
motor memory
consolidation
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases