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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03886090
Other study ID # DSN-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date February 24, 2020

Study information

Verified date March 2020
Source University of Erlangen-Nürnberg
Contact n/a
Is FDA regulated No
Health authority
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 a single bout of moderate-intense aerobic exercise, performed immediately following motor skill practice, 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) cardiovascular exercise can facilitate motor skill learning. However, this evidence is mainly derived from studying healthy individuals. In a first study including PD patients, we recently found improved motor memory consolidation, but not skill acquisition, when practice was preceded by a single bout of cardiovascular exercise.

These results suggest that acute exercise may enhance motor memory formation processes, but could potentially interfere with motor skill acquisition when performed prior to practice. Consequently, the present study investigates whether performing a single bout of cardiovascular exercise immediately following skill practice will enhance motor memory consolidation without affecting skill acquisition in PD.

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. Subsequently, motor skill retention will be tested after 24 hour and seven-days.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 24, 2020
Est. primary completion date February 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Parkinson's disease stage 1-3 on Hoehn & Yahr scale

- Ability to stand unaided and walk without an assistive device

- Stable medication during the study period

- Unfamiliar to the motor learning task

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
aerobic exercise
Single-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice
rest
Seated rest following motor skill practice
motor learning
Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in a horizontal position.

Locations

Country Name City State
Germany Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport, Gebbertstr. 123b Erlangen Bavaria

Sponsors (4)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg, German Foundation for Neurology, Klinik für Neurologie, Krankenhaus Rummelsberg

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) from skill practice (last block of skill acquisition) to 24-hour and seven-day retention test. Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
Secondary Root mean square error (RMSE) Memory consolidation: Change of root mean square error (average angular deviation from horizontal) from skill practice (last block of skill acquisition) to one-day and seven-day retention test. Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
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