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Completed

NCT Number: NCT04653285

Facilitating Motor Skill Learning in Parkinson's Disease III

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Heidelberg, Bade-Wuerttemberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

motor skill practice

Behavioral

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

Behavioral

A bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice.

Rest

Behavioral

Seated rest following motor skill practice.

Primary outcomes

  1. Time in balance

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

    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.

Secondary outcomes

  1. Root mean square error (RMSE)

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

    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.

  2. Dual-Task-Performance: Counting Backwards

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

    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

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

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

    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

  4. Muscular Endurance: Five Times Sit to Stand Test

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

    Strength Endurance: Change of time necessary to rise five times from a chair

  5. BDNF - Levels (Brain-derived neurotrophic factor)

    Time frame: 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

    Change of BDNF - Concentration in Blood samples

  6. VO2 max Level

    Time frame: Week 1: VO2max at baseline; Week 8: VO2max at seven day retention

    Maximum oxygen uptake and overall effect on cardiovascular fitness level: submaximal stress test on bicycle ergometer

  7. Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Score

    Time frame: Week 1: score at baseline; Week 8: score at seven day retention

    Parkinson Disease Rating Score (motor section): Change of UPDRS Score; minimum value: 0; maximum value: 132; higher scores indicate worse outcome

  8. Montreal Cognitive Assessment Score (MoCA - Score)

    Time frame: Week 1: score at baseline; Week 8: score at seven day retention

    Cognitive capability: Montreal Cognitive Assessment Score; minimum value: 0; maximum value: 30; higher scores indicate better outcome

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg

Other

Collaborators

  • German Foundation for Neurology
  • Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital

Registry information

Official study title

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

Acronym: FaST-PD-III

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2020
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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