Exercise the Mind and Brain. A Multimodal Intervention in Stroke (Mindfit)
2022년 3월 1일 업데이트: Maria Mataro Serrat, University of Barcelona
Effects of Combined Therapies of Physical Exercise, Mindfulness and Cognitive Stimulation on Cognition and Neuroplasticity in Chronic Stroke Patients: A Randomized Controlled Trial
The main objective of MindFit Project is to develop an evidence-based multimodal investigation of combined non-pharmacological strategies in chronic stroke patients and clarify the neuroplasticity mechanisms underlying the benefits of physical exercise and mindfulness strategies combined with cognitive training on post-stroke recovery.
The investigators have adopted a multidisciplinary and multimodal approach to provide a more integrative perspective using cognitive, social-psychological, biochemical, and neuroimaging measurements.
연구 개요
상태
완전한
정황
상세 설명
The MindFit Project is a multicentric, prospective, parallel, single-blinded, randomized controlled trial with a sample of 141 participants at 3 to 60 months after stroke. Participants are randomly allocated to one of three arms (through a simple randomizing procedure with a 1:1:1 ratio created with a random sequence generator software).
The first group (n=47) receives computer-based cognitive training (CCT) combined with a multicomponent physical exercise program. The second group (n=47) receives CCT combined with mindfulness-based stress reduction therapy. Finally, the third group (n=47), as an active control group, receives only CCT. All interventions last 12 weeks.
Within two weeks before the start of the interventions, and again at 3 months after completing the interventions, medical, cognitive, and physical assessments, neuroimaging, and biological samples collection are performed.
The objectives of this project are:
- To examine the effects of multimodal interventions in a population of chronic stroke patients on various domains: cognition, emotion, physical health, and quality of life.
- To examine specific plasticity effects of each of the three interventions regarding structural and functional magnetic resonance imaging (MRI) and how these changes may contribute to cognitive and emotional benefits.
- To study the molecular mechanisms by which the different types of interventions influence cognitive, emotional and brain benefits.
- To study interventions-induced microbiome changes and to explain how these changes may induce inflammatory and immune responses that may contribute to cognitive, emotional and brain benefits.
- To determine the demographic, clinical and genetic factors that may modulate cognitive, emotional and brain changes: baseline cognitive status; baseline cerebral status (atrophy, total intracranial volume); sex; age, educational level, intelligence.
연구 유형
중재적
등록 (실제)
141
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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Barcelona, 스페인
- Maria Mataro
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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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Individuals aged 18-80 years old
- Ischemic or hemorrhagic stroke
- Stroke diagnoses between 3-60 months ago
- To have consent from a physician to engage in an exercise intervention
- Fluency in Catalan or Spanish (I.e., able to understand and speak)
- Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.
Exclusion Criteria:
- Cognitive impairment (MMSE > 23)
- Severe aphasia (item 9 of the NIHSS scale ≥ 2)
- Severe sensory problems
- Other neurological conditions apart from stroke
- Severe pre-stroke psychiatric disorders (e.g., bipolar disorder, schizophrenia)
- History of alcohol or other toxic abuse
Exclusion criteria only for MRI examination:
- Claustrophobia
- Medical device (e.g., pacemaker implants, stents)
- Other metal objects in the body
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Physical exercise & cognitive training group
The Physical exercise & cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.
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The proposed physical exercise intervention follows the American College of Sports Medicine (ACSM, 2017) and the American Stroke Association (Billinger et al., 2014) recommendations for stroke patients.
The five weekly 45-minute sessions are divided into (1) three sessions guided and supervised telematically by a physical exercise specialist and a physiotherapist; (2) and two autonomous exercise sessions.
The supervised sessions include exercises to work aerobic capacity, muscle strength and endurance, flexibility, agility, and balance.
The intensity of these exercises is prescribed individually according to each participant's initial level and are gradually increased as the program progresses.
Participants are encouraged to walk at a similar intensity on autonomous physical exercise days as performed in the guided sessions (moderate intensity), based on the Borg scale of perceived exertion (Borg, 1982).
An accredited neuropsychologist programs and supervises the computerized cognitive training through the Guttmann Neuropersonal Trainer (GNPT®) platform.
The 12-week program consists of five sessions a week (45 minutes each) that include personalized activities planned to stimulate executive functioning, attention, processing speed, and memory.
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실험적: Mindfulness & cognitive training group
The Mindfulness & cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.
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An accredited neuropsychologist programs and supervises the computerized cognitive training through the Guttmann Neuropersonal Trainer (GNPT®) platform.
The 12-week program consists of five sessions a week (45 minutes each) that include personalized activities planned to stimulate executive functioning, attention, processing speed, and memory.
This intervention follows an adaptation of the scheme and instructions of the official Mindfulness-Based Stress Reduction (MBSR) program designed by Jon Kabat-Zinn.
It includes body scanning, sitting meditation, and gentle hatha yoga techniques.
An accredited mindfulness instructor leads the 12-week online program, which comprises a presentation session, followed by eight intervention sessions (once a week, lasting 2.5 hours) and an intensive practice session interspersed between sessions six and seven.
Apart from the supervised session, the therapist asks participants to carry out some independent practice daily.
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활성 비교기: Cognitive training group
The Cognitive training group, as an active control group, receives only computer-based cognitive training.
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An accredited neuropsychologist programs and supervises the computerized cognitive training through the Guttmann Neuropersonal Trainer (GNPT®) platform.
The 12-week program consists of five sessions a week (45 minutes each) that include personalized activities planned to stimulate executive functioning, attention, processing speed, and memory.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in immediate verbal attention after receiving treatment
기간: 3 months (at baseline, 3 months from baseline)
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Forward Digit Span (WAIS III)
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3 months (at baseline, 3 months from baseline)
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Change in verbal digit working memory after receiving treatment
기간: 3 months (at baseline, 3 months from baseline)
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Backward Digit Span (WAIS III)
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3 months (at baseline, 3 months from baseline)
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Change in verbal memory after receiving treatment
기간: 3 months (at baseline, 3 months from baseline)
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Rey Auditory Learning Test
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3 months (at baseline, 3 months from baseline)
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Change in visual memory after receiving treatment
기간: 3 months (at baseline, 3 months from baseline)
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Rey's Complex Figure Test
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3 months (at baseline, 3 months from baseline)
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Change in executive function, verbal fluency after receiving treatment
기간: 3 months (at baseline, 3 months from baseline)
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Phonetic Fluency is measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animal
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3 months (at baseline, 3 months from baseline)
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Change in executive function, inhibition after receiving treatment
기간: 3 months (at baseline, 3 months from baseline)
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Stroop Test
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3 months (at baseline, 3 months from baseline)
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Change in executive function, set-switching task after receiving treatment
기간: 3 months (at baseline, 3 months from baseline)
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Trail Making Test
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3 months (at baseline, 3 months from baseline)
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Change in language, naming after receiving treatment
기간: 3 months (at baseline, 3 months from baseline)
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Boston naming Test
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3 months (at baseline, 3 months from baseline)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in psychological distress
기간: 3 months (at baseline, 3 months from baseline)
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Clinical Outcomes in Routine Evaluation (CORE-OM)
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3 months (at baseline, 3 months from baseline)
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Changes in depression and anxiety
기간: 3 months (at baseline, 3 months from baseline)
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Depression Anxiety Stress Scale (DASS-21)
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3 months (at baseline, 3 months from baseline)
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Changes in wellbeing
기간: 3 months (at baseline, 3 months from baseline)
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Ryff Scales of Psychological Wellbeing.
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3 months (at baseline, 3 months from baseline)
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Changes in Mindfulness
기간: 3 months (at baseline, 3 months from baseline)
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Mindful Attention Awareness Scale (MAAS)
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3 months (at baseline, 3 months from baseline)
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Changes in White matter integrity
기간: 3 months (at baseline, 3 months from baseline)
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White matter integrity: tractography
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3 months (at baseline, 3 months from baseline)
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Changes in Resting-state connectivity
기간: 3 months (at baseline, 3 months from baseline)
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Resting state brain activity using fMRI
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3 months (at baseline, 3 months from baseline)
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Changes in brain volumetry
기간: 3 months (at baseline, 3 months from baseline)
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Grey and white matter volume measured by MRI
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3 months (at baseline, 3 months from baseline)
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Molecular changes: growth factors (BDNF, SDF1-a, VEGF-A, IGF-1, and NGF), cortisol, protein C reactive, IL-6 and homocysteine levels
기간: 3 months (at baseline, 3 months from baseline)
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Quantification of different biomarkers from blood samples.
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3 months (at baseline, 3 months from baseline)
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Changes in Microbiota data
기간: 3 months (at baseline, 3 months from baseline)
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Bacterial composition of stool samples in terms of relative abundance
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3 months (at baseline, 3 months from baseline)
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Changes in Sleep
기간: 3 months (at baseline, 3 months from baseline)
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Pittsburgh Sleep Quality Index (PSQI)
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3 months (at baseline, 3 months from baseline)
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Changes in Fitness
기간: 3 months (at baseline, 3 months from baseline)
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Senior Fitness Test (SFT)
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3 months (at baseline, 3 months from baseline)
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Changes in stroke specific quality of life
기간: 3 months (at baseline, 3 months from baseline)
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Stroke-specific Quality of Life Scale (ECVI-38)
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3 months (at baseline, 3 months from baseline)
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Changes in quality of life
기간: 3 months (at baseline, 3 months from baseline)
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World Health Organization Quality of Life (WHOQOL-BREF)
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3 months (at baseline, 3 months from baseline)
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Changes in mental fatigue
기간: 3 months (at baseline, 3 months from baseline)
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Fatigue Assessment Scale (FAS)
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3 months (at baseline, 3 months from baseline)
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Changes in physical activity:
기간: 3 months (at baseline, 3 months from baseline)
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Spanish version of the reduced Minnesota leisure-time physical and activity questionnaire (VREM)
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3 months (at baseline, 3 months from baseline)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Maria Mataró, PhD, University of Barcelona
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 (실제)
2020년 10월 28일
기본 완료 (실제)
2021년 7월 30일
연구 완료 (실제)
2022년 1월 30일
연구 등록 날짜
최초 제출
2020년 12월 31일
QC 기준을 충족하는 최초 제출
2021년 2월 15일
처음 게시됨 (실제)
2021년 2월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 3월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 3월 1일
마지막으로 확인됨
2022년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- University of Barcelona
- 201717.30.31.32 (기타 보조금/기금 번호: La Marato de TV3)
개별 참가자 데이터(IPD) 계획
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아니요
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아니
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아니
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. .
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