NCT03245216

Brief Summary

The study is designed to assess the effects of aerobic exercise on motor learning in Parkinson patients. Specifically, the investigators examine whether a single bout of moderate intensity aerobic exercise, performed immediately before task practice, facilitates the acquisition and retention of a motor skill. In a cross-over design, participants will be randomly allocated to either the intervention group (aerobic exercise before motor learning) or control group (rest before motor learning).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2017

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

March 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

July 31, 2017

Last Update Submit

October 23, 2018

Conditions

Parkinson Disease

Keywords

Parkinson's Diseasemotor learningaerobic exercisecardiovascular exercisebalancepostural instabilitymotor skill

Outcome Measures

Primary Outcomes (1)

  • Motor Learning (Precision)

    Change from baseline in time in balance (±5° from horizontal) during balancing task.

    Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).

Secondary Outcomes (1)

  • Motor Learning (Variability)

    Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).

Study Arms (2)

aerobic exercise + motor skill practice

EXPERIMENTAL

acute bout of aerobic exercise before motor learning

Behavioral: aerobic exerciseBehavioral: motor learning

rest + motor skill practice

ACTIVE COMPARATOR

seated rest before motor learning

Behavioral: restBehavioral: motor learning

Interventions

aerobic exerciseBEHAVIORAL

Single-bout of moderate intensity aerobic exercise on a cycle ergometer before motor learning

aerobic exercise + motor skill practice
restBEHAVIORAL

Seated rest before motor learning

rest + motor skill practice
motor learningBEHAVIORAL

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

aerobic exercise + motor skill practicerest + motor skill practice

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

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-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b

Erlangen, 91058, Germany

Location

Related Publications (1)

  • Steib S, Wanner P, Adler W, Winkler J, Klucken J, Pfeifer K. A Single Bout of Aerobic Exercise Improves Motor Skill Consolidation in Parkinson's Disease. Front Aging Neurosci. 2018 Oct 22;10:328. doi: 10.3389/fnagi.2018.00328. eCollection 2018.

    PMID: 30405397DERIVED

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-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 10, 2017

Study Start

March 1, 2017

Primary Completion

May 31, 2018

Study Completion

September 30, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations

DE(1)