Parkinson DiseaseFaST-PD-IIINCT04653285
Facilitating Motor Skill Learning in Parkinson's Disease III
A study testing motor skill practice, aerobic exercise and rest 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 moderate-intense aerobic exercise, performed immediately following motor skill practice over the course of a six week intervention period… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- motor skill practice, aerobic exercise and rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2022to 15 Apr 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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
Heidelberg University, Institute of Sport and Sport Science, Im Neuenheimer Feld 720
Heidelberg, Bade-Wuerttemberg, 69120
About this study
Official title: Facilitating Motor Skill Learning by Aerobic Training 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).
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) 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.
- Conditions
- Parkinson Disease
- Being tested
- motor skill practice, aerobic exercise, rest
- 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.
motor skill practiceBehavioural
Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.
aerobic exerciseBehavioural
A bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice.
restBehavioural
Seated rest following motor skill practice.
| Study group | Role | What they receive |
|---|---|---|
| motor skill practice + aerobic exercise | Experimental | bout of aerobic exercise following motor skill practice Receives: Behavioral: motor skill practice; Behavioral: aerobic exercise |
| motor skill practice + rest | Active comparator | seated rest following motor skill practice Receives: Behavioral: motor skill practice; Behavioral: rest |
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) over the course of all six skill practice sessions and the seven day retention test.
Measured: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
Secondary outcomes (8)
Root mean square error (RMSE)
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.
Measured: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
Dual-Task-Performance: Counting Backwards
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
Measured: Week 1: performance at baseline; Week 8: performance at seven day retention
Transfer Test Performance: Fullerton Advanced Balance Scale (FAB - Scale)
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
Measured: Week 1: performance at baseline; Week 8: performance at seven day retention
Muscular Endurance: Five Times Sit to Stand Test
Strength Endurance: Change of time necessary to rise five times from a chair
Measured: Week 1: performance at baseline; Week 8: performance at seven day retention
BDNF - Levels (Brain-derived neurotrophic factor)
Change of BDNF - Concentration in Blood samples
Measured: 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
VO2 max Level
Maximum oxygen uptake and overall effect on cardiovascular fitness level: submaximal stress test on bicycle ergometer
Measured: Week 1: VO2max at baseline; Week 8: VO2max at seven day retention
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Score
Parkinson Disease Rating Score (motor section): Change of UPDRS Score; minimum value: 0; maximum value: 132; higher scores indicate worse outcome
Measured: Week 1: score at baseline; Week 8: score at seven day retention
Montreal Cognitive Assessment Score (MoCA - Score)
Cognitive capability: Montreal Cognitive Assessment Score; minimum value: 0; maximum value: 30; higher scores indicate better outcome
Measured: Week 1: score at baseline; Week 8: score at seven day retention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jul 2022
- Primary completion8 Apr 2024
- Study completion15 Apr 2024
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Foundation for Neurology, Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital
- Responsible party
- Principal investigator, Simon Steib, PhD, University of Erlangen-Nürnberg
- Investigators
- Simon Steib, Dr., Principal investigator, Institute of Sport and Sport Science, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653285
- Sponsor's protocol ID
- DSN-2020
- Acronym
- FaST-PD-III
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2020
- Last updated
- 10 Dec 2024
- 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 10 Dec 2024. 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 III
- ClinicalTrials.gov ID
- NCT04653285
- Acronym / sponsor ID
- FaST-PD-III / DSN-2020
- 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
- 24 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- German Foundation for Neurology, Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 4 Dec 2020 (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 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.
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: motor skill practice, Behavioral: aerobic exercisebout of aerobic exercise following motor skill practice |
| motor skill practice + rest | Active comparator | Behavioral: motor skill practice, Behavioral: restseated rest following motor skill practice |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| motor skill practiceMotor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s. | Behavioural | motor skill practice + aerobic exercise, motor skill practice + rest |
| aerobic exerciseA 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 |
Primary outcome
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.
8 secondary outcomes
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
Dual-Task-Performance: Counting Backwards
Time frame: Week 1: performance at baseline; Week 8: performance at seven day retention
Transfer Test Performance: Fullerton Advanced Balance Scale (FAB - Scale)
Time frame: Week 1: performance at baseline; Week 8: performance at seven day retention
Muscular Endurance: Five Times Sit to Stand Test
Time frame: Week 1: performance at baseline; Week 8: performance at seven day retention
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
VO2 max Level
Time frame: Week 1: VO2max at baseline; Week 8: VO2max at seven day retention
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Score
Time frame: Week 1: score at baseline; Week 8: score at seven day retention
Montreal Cognitive Assessment Score (MoCA - Score)
Time frame: Week 1: score at baseline; Week 8: score at seven day retention
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 10 Dec 2024.
- 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
Institute of Sport and Sport Science, Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor skill practice, aerobic exercise and rest 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 10 Dec 2024. 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: Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: 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 10 Dec 2024.