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Facilitating Motor Skill Learning in Parkinson's Disease III (FaST-PD-III)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
motor skill practice
aerobic exercise
rest
Sponsored by
University of Erlangen-Nürnberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, motor learning, neuroplasticity, aerobic exercise, cardiovascular exercise, balance, postural instability, motor memory, consolidation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

motor skill practice + aerobic exercise

motor skill practice + rest

Arm Description

bout of aerobic exercise following motor skill practice

seated rest following motor skill practice

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
Muscular Endurance: Five Times Sit to Stand Test
Strength Endurance: Change of time necessary to rise five times from a chair
BDNF - Levels (Brain-derived neurotrophic factor)
Change of BDNF - Concentration in Blood samples
VO2 max Level
Maximum oxygen uptake and overall effect on cardiovascular fitness level: submaximal stress test on bicycle ergometer
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
Montreal Cognitive Assessment Score (MoCA - Score)
Cognitive capability: Montreal Cognitive Assessment Score; minimum value: 0; maximum value: 30; higher scores indicate better outcome

Full Information

First Posted
October 12, 2020
Last Updated
November 4, 2022
Sponsor
University of Erlangen-Nürnberg
Collaborators
German Foundation for Neurology, Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital
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1. Study Identification

Unique Protocol Identification Number
NCT04653285
Brief Title
Facilitating Motor Skill Learning in Parkinson's Disease III
Acronym
FaST-PD-III
Official Title
Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease III
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg
Collaborators
German Foundation for Neurology, Klinik für Neurologie, Klinikum Würzburg Mitte, Standort Juliusspital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, motor learning, neuroplasticity, aerobic exercise, cardiovascular exercise, balance, postural instability, motor memory, consolidation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
motor skill practice + aerobic exercise
Arm Type
Experimental
Arm Description
bout of aerobic exercise following motor skill practice
Arm Title
motor skill practice + rest
Arm Type
Active Comparator
Arm Description
seated rest following motor skill practice
Intervention Type
Behavioral
Intervention Name(s)
motor skill practice
Intervention Description
Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
A bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice.
Intervention Type
Behavioral
Intervention Name(s)
rest
Intervention Description
Seated rest following motor skill practice.
Primary Outcome Measure Information:
Title
Time in balance
Description
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.
Time Frame
Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
Secondary Outcome Measure Information:
Title
Root mean square error (RMSE)
Description
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.
Time Frame
Week 1: performance at Baseline, Week 2 - 7: performance at practice session, Week 8: seven day retention performance
Title
Dual-Task-Performance: Counting Backwards
Description
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
Time Frame
Week 1: performance at baseline; Week 8: performance at seven day retention
Title
Transfer Test Performance: Fullerton Advanced Balance Scale (FAB - Scale)
Description
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
Time Frame
Week 1: performance at baseline; Week 8: performance at seven day retention
Title
Muscular Endurance: Five Times Sit to Stand Test
Description
Strength Endurance: Change of time necessary to rise five times from a chair
Time Frame
Week 1: performance at baseline; Week 8: performance at seven day retention
Title
BDNF - Levels (Brain-derived neurotrophic factor)
Description
Change of BDNF - Concentration in Blood samples
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
Title
VO2 max Level
Description
Maximum oxygen uptake and overall effect on cardiovascular fitness level: submaximal stress test on bicycle ergometer
Time Frame
Week 1: VO2max at baseline; Week 8: VO2max at seven day retention
Title
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Score
Description
Parkinson Disease Rating Score (motor section): Change of UPDRS Score; minimum value: 0; maximum value: 132; higher scores indicate worse outcome
Time Frame
Week 1: score at baseline; Week 8: score at seven day retention
Title
Montreal Cognitive Assessment Score (MoCA - Score)
Description
Cognitive capability: Montreal Cognitive Assessment Score; minimum value: 0; maximum value: 30; higher scores indicate better outcome
Time Frame
Week 1: score at baseline; Week 8: score at seven day retention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Steib, Dr.
Phone
0049 6221544643
Email
simon.steib@issw.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Wanner, Dr.
Phone
0049 6221544633
Email
philipp.wanner@issw.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Steib, Dr.
Organizational Affiliation
Institute of Sport and Sport Science, Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heidelberg University, Institute of Sport and Sport Science, Im Neuenheimer Feld 720
City
Heidelberg
State/Province
Bade-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Steib, Dr.
Phone
0049 6221 544643
Email
simon.steib@issw.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Philipp Wanner, Dr.
Phone
0049 6221 544633
Email
philipp.wanner@issw.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Simon Steib, Dr.
First Name & Middle Initial & Last Name & Degree
Wanner Philipp, Dr.
First Name & Middle Initial & Last Name & Degree
Ostermair Florian, MSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.sport.fau.eu/das-institut/forschung/bewegung-und-gesundheit/forschungsprojekte/optimierung-motorischer-lernprozesse-in-der-rehabilitation-von-parkinsonpatienten/
Description
project website

Learn more about this trial

Facilitating Motor Skill Learning in Parkinson's Disease III

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