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

November 29, 2023 updated by: Simon Steib, PhD, University of Erlangen-Nürnberg

Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease III

The study is designed to assess the effects of cardiovascular (aerobic) exercise on motor skill learning in Parkinson patients. Specifically, the investigators examine whether moderate-intense aerobic exercise, performed immediately following motor skill practice over the course of a six week intervention period, 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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) and chronic (multiple 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, the investigators recently found improved motor memory consolidation, but not improved skill acquisition, when practice was preceded by a single bout of cardiovascular exercise.

These results suggested that acute exercise may enhance motor memory formation processes, but could potentially interfere with motor skill acquisition when performed prior to practice. Consequently, in a second study the investigators examined whether performing a single bout of cardiovascular exercise immediately following skill practice would enhance motor memory consolidation without affecting skill acquisition in PD. The results of this second study suggested that even a single moderate intense bout performed immediately following skill practice improves motor memory consolidation in PD patients.

Going onward from the previous two studies, the present study will investigate the effects of performing cardiovascular exercise immediately following skill practice over the course of a six week intervention period on motor memory consolidation. It will be examined how the regular direct coupling of motor learning skill practice and cardiovascular exercise influences the consolidation and automation of the practiced movements.

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. This intervention will be held over a period of six weeks. Subsequently, motor skill retention will be tested seven days after the last training session.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bade-Wuerttemberg
      • Heidelberg, Bade-Wuerttemberg, Germany, 69120
        • Recruiting
        • Heidelberg University, Institute of Sport and Sport Science, Im Neuenheimer Feld 720
        • Contact:
        • Contact:
        • Principal Investigator:
          • Simon Steib, Dr.
        • Sub-Investigator:
          • Wanner Philipp, Dr.
        • Sub-Investigator:
          • Ostermair Florian, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Parkinson's disease stage 1-3,5 on Hoehn & Yahr scale
  • Ability to stand unaided and walk without an assistive device
  • Stable medication during the study period
  • Unfamiliar to the motor task (stabilometer)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: motor skill practice + aerobic exercise
bout of aerobic exercise following motor skill practice
Behavioral: motor skill practice
Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.
Behavioral: aerobic exercise
A bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice.
Active Comparator: motor skill practice + rest
seated rest following motor skill practice
Behavioral: motor skill practice
Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.
Behavioral: rest
Seated rest following motor skill practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in balance
Time Frame: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
Motor memory consolidation: Change of time in balance (angular displacement ±5° from horizontal) over the course of all six skill practice sessions and the seven day retention test.
Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root mean square error (RMSE)
Time Frame: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
Memory consolidation: Change of root mean square error (average angular deviation from horizontal) over the course of all six skill practice sessions and the seven day retention test.
Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
Dual-Task-Performance: Counting Backwards
Time Frame: Week 1: performance at baseline; Week 8: performance at seven day retention
Motor memory automatization: Change of time in balance (angular displacement ±5° from horizontal) in addition to error score of a backwards-counting-task from Pre- to Post-Assessment
Week 1: performance at baseline; Week 8: performance at seven day retention
Transfer Test Performance: Fullerton Advanced Balance Scale (FAB - Scale)
Time Frame: Week 1: performance at baseline; Week 8: performance at seven day retention
Transfer Effects of Balance: Change of the achieved score on the FAB - Scale from Pre- to Post- Assessment; minimum value: 0; maximum value: 40; higher scores indicate better outcome
Week 1: performance at baseline; Week 8: performance at seven day retention
Muscular Endurance: Five Times Sit to Stand Test
Time Frame: Week 1: performance at baseline; Week 8: performance at seven day retention
Strength Endurance: Change of time necessary to rise five times from a chair
Week 1: performance at baseline; Week 8: performance at seven day retention
BDNF - Levels (Brain-derived neurotrophic factor)
Time Frame: Week 1: BDNF concentration at baseline; Week 2 a + b: BDNF concentration before (a) and after (b) Intervention; Session: 7 a + b: BDNF concentration before (a) and after (b) Intervention; Week 8: BDNF concentration at seven day retention
Change of BDNF - Concentration in Blood samples
Week 1: BDNF concentration at baseline; Week 2 a + b: BDNF concentration before (a) and after (b) Intervention; Session: 7 a + b: BDNF concentration before (a) and after (b) Intervention; Week 8: BDNF concentration at seven day retention
VO2 max Level
Time Frame: Week 1: VO2max at baseline; Week 8: VO2max at seven day retention
Maximum oxygen uptake and overall effect on cardiovascular fitness level: submaximal stress test on bicycle ergometer
Week 1: VO2max at baseline; Week 8: VO2max at seven day retention
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Score
Time Frame: Week 1: score at baseline; Week 8: score at seven day retention
Parkinson Disease Rating Score (motor section): Change of UPDRS Score; minimum value: 0; maximum value: 132; higher scores indicate worse outcome
Week 1: score at baseline; Week 8: score at seven day retention
Montreal Cognitive Assessment Score (MoCA - Score)
Time Frame: Week 1: score at baseline; Week 8: score at seven day retention
Cognitive capability: Montreal Cognitive Assessment Score; minimum value: 0; maximum value: 30; higher scores indicate better outcome
Week 1: score at baseline; Week 8: score at seven day retention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg

Collaborators

German Foundation for Neurology
Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital

Investigators

  • Principal Investigator: Simon Steib, Dr., Institute of Sport and Sport Science, Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 12, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSN-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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