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

NCT ID: NCT03886090

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

motor skill practice + aerobic exercise

acute bout of aerobic exercise following motor skill practice

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type BEHAVIORAL

Single-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice

motor learning

Intervention Type BEHAVIORAL

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

motor skill practice + rest

seated rest following motor skill practice

Group Type ACTIVE_COMPARATOR

rest

Intervention Type BEHAVIORAL

Seated rest following motor skill practice

motor learning

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aerobic exercise

Single-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice

Intervention Type BEHAVIORAL

rest

Seated rest following motor skill practice

Intervention Type BEHAVIORAL

motor learning

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

German Foundation for Neurology

OTHER

Sponsor Role collaborator

Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg

OTHER

Sponsor Role collaborator

Klinik für Neurologie, Krankenhaus Rummelsberg

UNKNOWN

Sponsor Role collaborator

University of Erlangen-Nürnberg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Simon Steib, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Simon Steib, Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport, Gebbertstr. 123b

Erlangen, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DSN-2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.