Clinical trial NCT04653285: Facilitating Motor Skill Learning in Parkinson's Disease III
Official title: Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
motor learning
neuroplasticity
aerobic exercise
cardiovascular exercise
balance
postural instability
motor memory
consolidation
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: German Foundation for Neurology
name: Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital
First posted: 2020-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in balance
timeFrame: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
Secondary outcomes:
measure: Root mean square error (RMSE)
timeFrame: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
measure: Dual-Task-Performance: Counting Backwards
timeFrame: Week 1: performance at baseline; Week 8: performance at seven day retention
measure: Transfer Test Performance: Fullerton Advanced Balance Scale (FAB - Scale)
timeFrame: Week 1: performance at baseline; Week 8: performance at seven day retention
measure: Muscular Endurance: Five Times Sit to Stand Test
timeFrame: Week 1: performance at baseline; Week 8: performance at seven day retention
measure: BDNF - Levels (Brain-derived neurotrophic factor)
timeFrame: 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
measure: VO2 max Level
timeFrame: Week 1: VO2max at baseline; Week 8: VO2max at seven day retention
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Score
timeFrame: Week 1: score at baseline; Week 8: score at seven day retention
measure: Montreal Cognitive Assessment Score (MoCA - Score)
timeFrame: Week 1: score at baseline; Week 8: score at seven day retention
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University, Institute of Sport and Sport Science, Im Neuenheimer Feld 720
state: Bade-Wuerttemberg
Study officials:
affiliation: Institute of Sport and Sport Science, Heidelberg University
name: Simon Steib, Dr.
role: PRINCIPAL_INVESTIGATOR
References: