NCT04653285

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 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2022

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

First Submitted

Initial submission to the registry

October 12, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

October 12, 2020

Last Update Submit

December 7, 2024

Conditions

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) 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 Outcomes (8)

  • Root mean square error (RMSE)

    Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance

  • Dual-Task-Performance: Counting Backwards

    Week 1: performance at baseline; Week 8: performance at seven day retention

  • Transfer Test Performance: Fullerton Advanced Balance Scale (FAB - Scale)

    Week 1: performance at baseline; Week 8: performance at seven day retention

  • Muscular Endurance: Five Times Sit to Stand Test

    Week 1: performance at baseline; Week 8: performance at seven day retention

  • BDNF - Levels (Brain-derived neurotrophic factor)

    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

  • +3 more secondary outcomes

Study Arms (2)

motor skill practice + aerobic exercise

EXPERIMENTAL

bout of aerobic exercise following motor skill practice

Behavioral: motor skill practiceBehavioral: aerobic exercise

motor skill practice + rest

ACTIVE COMPARATOR

seated rest following motor skill practice

Behavioral: motor skill practiceBehavioral: rest

Interventions

Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.

motor skill practice + aerobic exercisemotor skill practice + rest

A 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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

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)

Heidelberg University, Institute of Sport and Sport Science, Im Neuenheimer Feld 720

Heidelberg, Bade-Wuerttemberg, 69120, 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.

    Institute of Sport and Sport Science, Heidelberg University

    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

October 12, 2020

First Posted

December 4, 2020

Study Start

July 1, 2022

Primary Completion

April 8, 2024

Study Completion

April 15, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations