Parkinson DiseaseFaST-PD IINCT03886090
Facilitating Motor Skill Learning in Parkinson's Disease II (FaST-PD II)
A study testing aerobic exercise, rest and motor learning in people with Parkinson Disease, run by University of Erlangen-Nürnberg at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- aerobic exercise, rest and motor learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 24 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport, Gebbertstr. 123b
Erlangen, Bavaria, 91058
About this study
Official title: Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease II
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).
Read the 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) 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.
- Conditions
- Parkinson Disease
- Being tested
- aerobic exercise, rest, motor learning
- Keywords
- Parkinson's Disease, motor learning, neuroplasticity, aerobic exercise, cardiovascular exercise, balance, postural instability, motor memory, consolidation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
Single-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice
restBehavioural
Seated rest following motor skill practice
motor learningBehavioural
Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in a horizontal position.
| Study group | Role | What they receive |
|---|---|---|
| motor skill practice + aerobic exercise | Experimental | acute bout of aerobic exercise following motor skill practice Receives: Behavioral: aerobic exercise; Behavioral: motor learning |
| motor skill practice + rest | Active comparator | seated rest following motor skill practice Receives: Behavioral: rest; Behavioral: motor learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
Secondary outcomes (1)
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.
Measured: Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Jan 2019
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Foundation for Neurology, Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg, Klinik für Neurologie, Krankenhaus Rummelsberg
- Responsible party
- Principal investigator, Simon Steib, PhD, University of Erlangen-Nürnberg
- Investigators
- Simon Steib, Dr., Principal investigator, Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886090
- Sponsor's protocol ID
- DSN-2018
- Acronym
- FaST-PD II
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease II
- ClinicalTrials.gov ID
- NCT03886090
- Acronym / sponsor ID
- FaST-PD II / DSN-2018
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, motor learning, neuroplasticity, aerobic exercise, cardiovascular exercise, balance, postural instability, motor memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- German Foundation for Neurology, Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg, Klinik für Neurologie, Krankenhaus Rummelsberg
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| motor skill practice + aerobic exercise | Experimental | Behavioral: aerobic exercise, Behavioral: motor learningacute bout of aerobic exercise following motor skill practice |
| motor skill practice + rest | Active comparator | Behavioral: rest, Behavioral: motor learningseated rest following motor skill practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- On-off and wearing-off phenomena
- Unstable medical or psychiatric illness
- Clinically relevant cardiovascular or orthopaedic disease
- Severe polyneuropathy
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exerciseSingle-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice | Behavioural | motor skill practice + aerobic exercise |
| restSeated rest following motor skill practice | Behavioural | motor skill practice + rest |
| motor learningMotor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in a horizontal position. | Behavioural | motor skill practice + aerobic exercise, motor skill practice + rest |
Primary outcome
Time in balance
Time frame: Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
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.
1 secondary outcome
Root mean square error (RMSE)
Time frame: Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Steib, Dr. principal investigator
Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise, rest and motor learning in people with Parkinson Disease, run by University of Erlangen-Nürnberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in balance (time frame: Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.