Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline
2016년 12월 19일 업데이트: Chang Gung Memorial Hospital
Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline.
The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.
연구 개요
상태
알려지지 않은
연구 유형
중재적
등록 (예상)
75
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Chiayi City, 대만, 613
- 모병
- Chiayi Chang Gung Memorial Hospital
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연락하다:
- Shi-Zhe Lin, MS
- 전화번호: 2688 +886-5-3621000
- 이메일: apirlline@cgmh.org.tw
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Kaohsiung City, 대만, 83301
- 모병
- Kaohsiung Chang Gung Memorial Hospital
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연락하다:
- Ku-Chou Chang, MD
- 전화번호: 2285 +886-7317123
- 이메일: kcchang@cgmh.org.tw
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Keelung City, 대만, 204
- 모병
- Keeling Chang Gung Memorial Hospital
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연락하다:
- Chia-Ling Chen, PhD
- 전화번호: 8147 +886-3-3281200
- 이메일: ccl1374@adm.cgmh.com.tw
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Taipei City, 대만, 105
- 모병
- Taipei Chang Gung Memorial Hospital
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연락하다:
- Chia-Ling Chen, PhD
- 전화번호: 8147 +886-3-3281200
- 이메일: ccl1374@adm.cgmh.com.tw
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Taoyuan City, 대만, 333
- 모병
- Taoyuan Chang Gung Memorial Hospital
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연락하다:
- Chia-Ling Chen, PhD
- 전화번호: 8147 +886-3-3281200
- 이메일: ccl1374@adm.cgmh.com.tw
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Taoyuan
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Kwei-Shan, Taoyuan, 대만, 333
- 모병
- Chang Gung Memorial Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
- Age range from 20 to 90 years
- MMSE score ≥ 19
- MoCA<26
- Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
- Able to follow the study instruction
- Adequate cardiopulmonary function to perform aerobic exercise
- Able to walk with or without assistive devices
Exclusion Criteria:
- Unstable medical history (e.g., recent myocardial infarction) that might limit participation
- Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
- Current participation in another interventional trial
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Cognitive training group
One 60-min session of cognitive training.
Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.).
A saliva sample (2 mL) will only be collected once from each subject.
A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
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활성 비교기: Aerobic exercise training group
One 60-min session of aerobic exercise training.
Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.).
A saliva sample (2 mL) will only be collected once from each subject.
A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
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실험적: Sequential training group
One 30-min session of aerobic exercise training + one 30-min session of cognitive training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change scores of Montreal Cognitive Assessment (MoCA)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Useful Field of View (UFOV)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Stroop Color-Word test
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Dual-task test
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously.
The investigators will assess the dual-task performance during walking and performing box and block test.
The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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항산화 마커 점수 변경
기간: 베이스라인, 사후 테스트(예상 평균 3개월)
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항산화 마커는 산화 스트레스의 변화를 반영하는 데 사용됩니다.
특히, 총 항산화 능력(TAC)을 분석할 것입니다.
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베이스라인, 사후 테스트(예상 평균 3개월)
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혈장 지질 수치의 변화 점수
기간: 베이스라인, 사후 테스트(예상 평균 3개월)
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콜레스테롤 비율(총 콜레스테롤을 고밀도 지질로 나눈 값)은 혈중 지질 수준을 반영하기 위해 평가됩니다.
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베이스라인, 사후 테스트(예상 평균 3개월)
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Change scores of serum BDNF level
기간: Baseline, posttest (an expected average of 3 months)
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Baseline, posttest (an expected average of 3 months)
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Change scores of Glucose indicator
기간: Baseline, posttest (an expected average of 3 months)
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HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise.
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Baseline, posttest (an expected average of 3 months)
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Change scores of Functional Independence Measure (FIM)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Stroke Impact Scale (SIS)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Caregiver Burden (CB) scale
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of EuroQol (EQ)-5D questionnaire
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Timed up and go test (TUG)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Six-minute walk test (6MWT)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Mobility level
기간: Baseline, posttest (an expected average of 3 months)
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Baseline, posttest (an expected average of 3 months)
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Change scores of International Physical Activity Questionnaires (IPAQ)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Fugl-Meyer Assessment (FMA)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Rivermead Mobility Index (RMI)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of muscle strength
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer.
Also, we will use hand dynamometer to measure grip strength of the affected and less affected hand while the participant is seated, with the elbow at 90-degree flexion.
We will record the mean value of 3 attempts.
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Community Integration Questionnaire (CIQ)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Geriatric Depression Scale (GDS)
기간: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Genotyping of the BDNF val66met polymorphism
기간: Between baseline and posttest (an expected average of 3 months)
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Between baseline and posttest (an expected average of 3 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.
- Yeh TT, Wu CY, Hsieh YW, Chang KC, Lee LC, Hung JW, Lin KC, Teng CH, Liao YH. Synergistic effects of aerobic exercise and cognitive training on cognition, physiological markers, daily function, and quality of life in stroke survivors with cognitive decline: study protocol for a randomized controlled trial. Trials. 2017 Aug 31;18(1):405. doi: 10.1186/s13063-017-2153-7.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 9월 1일
기본 완료 (예상)
2018년 8월 1일
연구 등록 날짜
최초 제출
2015년 9월 6일
QC 기준을 충족하는 최초 제출
2015년 9월 14일
처음 게시됨 (추정)
2015년 9월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 12월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 12월 19일
마지막으로 확인됨
2016년 12월 1일
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. .