Facilitating Motor Skill Learning in Parkinson's Disease III

Parkinson Disease Clinical Trial

— FaST-PD-III  

Official title:

Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease III

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653285
• Other study ID #: DSN-2020
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: University of Erlangen-Nürnberg
• Contact: Simon Steib, Dr.
• Phone: 0049 6221544643
• Email: simon.steib[@]issw.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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) and chronic (multiple 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, the investigators recently found improved motor memory consolidation, but not improved skill acquisition, when practice was preceded by a single bout of cardiovascular exercise.

These results suggested that acute exercise may enhance motor memory formation processes, but could potentially interfere with motor skill acquisition when performed prior to practice. Consequently, in a second study the investigators examined whether performing a single bout of cardiovascular exercise immediately following skill practice would enhance motor memory consolidation without affecting skill acquisition in PD. The results of this second study suggested that even a single moderate intense bout performed immediately following skill practice improves motor memory consolidation in PD patients.

Going onward from the previous two studies, the present study will investigate the effects of performing cardiovascular exercise immediately following skill practice over the course of a six week intervention period on motor memory consolidation. It will be examined how the regular direct coupling of motor learning skill practice and cardiovascular exercise influences the consolidation and automation of the practiced movements.

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. This intervention will be held over a period of six weeks. Subsequently, motor skill retention will be tested seven days after the last training session.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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)

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• motor skill practice
Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.
• aerobic exercise
A bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice.
• rest
Seated rest following motor skill practice.

Locations

Country	Name	City	State
Germany	Heidelberg University, Institute of Sport and Sport Science, Im Neuenheimer Feld 720	Heidelberg	Bade-Wuerttemberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg	German Foundation for Neurology, Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Root mean square error (RMSE)	Memory consolidation: Change of root mean square error (average angular deviation 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	Dual-Task-Performance: Counting Backwards	Motor memory automatization: Change of time in balance (angular displacement ±5° from horizontal) in addition to error score of a backwards-counting-task from Pre- to Post-Assessment	Week 1: performance at baseline; Week 8: performance at seven day retention
Secondary	Transfer Test Performance: Fullerton Advanced Balance Scale (FAB - Scale)	Transfer Effects of Balance: Change of the achieved score on the FAB - Scale from Pre- to Post- Assessment; minimum value: 0; maximum value: 40; higher scores indicate better outcome	Week 1: performance at baseline; Week 8: performance at seven day retention
Secondary	Muscular Endurance: Five Times Sit to Stand Test	Strength Endurance: Change of time necessary to rise five times from a chair	Week 1: performance at baseline; Week 8: performance at seven day retention
Secondary	BDNF - Levels (Brain-derived neurotrophic factor)	Change of BDNF - Concentration in Blood samples	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
Secondary	VO2 max Level	Maximum oxygen uptake and overall effect on cardiovascular fitness level: submaximal stress test on bicycle ergometer	Week 1: VO2max at baseline; Week 8: VO2max at seven day retention
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Score	Parkinson Disease Rating Score (motor section): Change of UPDRS Score; minimum value: 0; maximum value: 132; higher scores indicate worse outcome	Week 1: score at baseline; Week 8: score at seven day retention
Secondary	Montreal Cognitive Assessment Score (MoCA - Score)	Cognitive capability: Montreal Cognitive Assessment Score; minimum value: 0; maximum value: 30; higher scores indicate better outcome	Week 1: score at baseline; Week 8: score at seven day retention

External Links

•   project website