NCT03886090

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

March 20, 2019

Last Update Submit

March 23, 2020

Conditions

Parkinson Disease

Keywords

Parkinson's Diseasemotor learningneuroplasticityaerobic exercisecardiovascular exercisebalancepostural instabilitymotor memoryconsolidation

Outcome Measures

Primary Outcomes (1)

  • Time in balance

    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.

    Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance

Secondary Outcomes (1)

  • Root mean square error (RMSE)

    Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance

Study Arms (2)

motor skill practice + aerobic exercise

EXPERIMENTAL

acute bout of aerobic exercise following motor skill practice

Behavioral: aerobic exerciseBehavioral: motor learning

motor skill practice + rest

ACTIVE COMPARATOR

seated rest following motor skill practice

Behavioral: restBehavioral: motor learning

Interventions

aerobic exerciseBEHAVIORAL

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

motor skill practice + aerobic exercise
restBEHAVIORAL

Seated rest following motor skill practice

motor skill practice + rest
motor learningBEHAVIORAL

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

motor skill practice + aerobic exercisemotor skill practice + rest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, Bavaria, 91058, Germany

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

ExerciseRE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Simon Steib, Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

January 1, 2019

Primary Completion

February 24, 2020

Study Completion

February 24, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

DE(1)