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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03245216
Other study ID # DSN-032017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date September 30, 2018

Study information

Verified date October 2018
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 aerobic exercise on motor learning in Parkinson patients. Specifically, the investigators examine whether a single bout of moderate intensity aerobic exercise, performed immediately before task practice, facilitates the acquisition and retention of a motor skill. In a cross-over design, participants will be randomly allocated to either the intervention group (aerobic exercise before motor learning) or control group (rest before motor learning).


Description:

Parkinson's disease 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 is consequently considered to be a motor learning process. While motor learning is preserved in persons with Parkinson's disease, slower acquisition rates and reduced retention have been reported compared to healthy individuals.

Thus, it is crucial to identify strategies to enhance motor learning in people with Parkinson's disease. Recent studies have accumulated evidence to show that aerobic exercise can facilitate motor skill learning. However, these observations are limited to healthy individuals and have not been addressed in individuals with neurologic conditions.

The present study is designed to assess the effects of a single bout of moderate intensity aerobic exercise on a motor skill learning task in patients with Parkinson's disease.

In a cross-over design, participants will be randomly allocated to one of two groups. Both groups will practice balancing on a specific stability platform (motor learning task). The experimental group will additionally perform a bout of aerobic exercise (cycle ergometer) immediately before the motor learning task, while the control group will rest before practice. Subsequently, the acquisition and one-day retention of the motor learning task will be examined.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 30, 2018
Est. primary completion date May 31, 2018
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

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 before motor learning
rest
Seated rest before motor learning
motor learning
Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in an horizontal position.

Locations

Country Name City State
Germany Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b Erlangen

Sponsors (3)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg, Deutsche Stiftung Neurologie (DSN)

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motor Learning (Precision) Change from baseline in time in balance (±5° from horizontal) during balancing task. Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).
Secondary Motor Learning (Variability) Change from baseline in mean standard deviation (root mean square error) of platform deflection (in degree). Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).
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