- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03886090
Facilitating Motor Skill Learning in Parkinson's Disease II (FaST-PD II) (FaST-PD II)
Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease II
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Bavaria
-
Erlangen, Bavaria, 독일, 91058
- Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport, Gebbertstr. 123b
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 운동 기술 연습 + 휴식
운동 기술 연습 후 앉은 휴식
|
Motor learning task on a stability platform (Stabilometer).
Participants try to keep the tiltable platform in a horizontal position.
Seated rest following motor skill practice
|
실험적: motor skill practice + aerobic exercise
acute bout of aerobic exercise following motor skill practice
|
Single-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice
Motor learning task on a stability platform (Stabilometer).
Participants try to keep the tiltable platform in a horizontal position.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Time in balance
기간: 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.
|
Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Root mean square error (RMSE)
기간: Day 1: performance at end of skill acquisition (last practice block), Day 2: 24-hour retention performance, Day 3: seven-day retention performance
|
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
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Simon Steib, Dr., Friedrich-Alexander University Erlangen-Nürnberg, Department of Sport Science and Sport
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
aerobic exercise에 대한 임상 시험
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for... 그리고 다른 협력자들완전한
-
The Hong Kong Polytechnic University완전한
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)완전한