Facilitating Motor Skill Learning in Parkinson's Disease III
FaST-PD-III
1 other identifier
interventional
24
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2020
CompletedFirst Posted
Study publicly available on registry
December 4, 2020
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedDecember 10, 2024
December 1, 2024
1.8 years
October 12, 2020
December 7, 2024
Conditions
Keywords
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
EXPERIMENTALbout of aerobic exercise following motor skill practice
motor skill practice + rest
ACTIVE COMPARATORseated rest following motor skill practice
Interventions
Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.
A bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice.
Eligibility Criteria
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Steib, Dr.
Institute of Sport and Sport Science, Heidelberg University
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