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

December 7, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Bade-Wuerttemberg
      • Heidelberg, Bade-Wuerttemberg, Germany, 69120
        • Heidelberg University, Institute of Sport and Sport Science, Im Neuenheimer Feld 720

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Foundation for Neurology
Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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