- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02869854
Increased Physical Activity Through Mindfulness (FAR-MIND)
Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.
연구 개요
상세 설명
All patients between 40 and 65 years of age who fulfills the inclusion criteria will be asked to participate in the study. Posters with information about the study will be put in the waiting room and on other strategic places. Patients who accept to participate will get both written and orally information, after the information they will sign a informed consent. The patients will estimate their level of physical activity in minutes per week to control inclusion criteria. The patients will return a morning for fasting blood samples and get an accelerometer attached to them to wear during 7 days. During this time randomization will be preformed. They will also get to answer a couple of different surveys. The results from the surveys and blood samples will be the study baseline.
All patients with abnormal test results will follow specific flow diagram for the usual care.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Skane
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Malmö, Skane, 스웨덴, 205 02
- Lunds Unniversitet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Individuals between 40-65 years of age, with insufficient physical activity ( <150 minutes of moderate-intensity physical activity throughout the week, or < 75 minutes of vigorous-intensity physical activity throughout the week, or an equivalent combination of moderate- and vigorous-intensity activity.)
Exclusion Criteria:
- Dementia, severe mental disorder,newly diagnosed untreated unstable angina pectoris,myocardial infarction within 6 weeks prior to study entry. Individuals who do not master the Swedish language in speech and writing will be excluded.The patients who have abnormal values according to guidelines that require contact with a physician on the same day or week will also be excluded
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: PAP only
This group will follow the referral scheme for three months, and after this period they will leave new blood samples and answer surveys.
They will get a new PAP with follow up after another 3 months.
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Physical Activity on Prescription, after 3 months a new prescription
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활성 비교기: Mindfulness only
Mindfulness.
This group will receive a group course in mindfulness during 8 weeks once a week, and with 20 minutes of daily personal training.
Three and six months after inclusion they will answer a new set of surveys and fasting blood samples.
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Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day
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실험적: Combination of the two groups
Mindfulness and physical activity prescription.
This group will get a combination of the two other groups.
PAP will be prescribed during the first meeting and another one after 3 months.
During the first 8 weeks once a week they will participate in a mindfulness training group and also preform 20 minutes of daily training.
The same surveys as the other groups and fasting blood samples
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Physical Activity on Prescription, after 3 months a new prescription
Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Difference of time, measured in minutes of activity during a week, between the three different groups measured by activity monitor Actigraph (GT3X)
기간: 6 months
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Each individual will wear an activity monitor during 7 days.
This will be done at baseline after 3 months and after 6 months
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Difference between the three groups in revised assessment of their self-rated health and
기간: 6 months
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assessment based on terms of perceived health with five alternative answers very poor, poor, fair, good and very good
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6 months
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Difference between groups in the amount of self-perceived sleep problems
기간: 6 months
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Insomnia Severity Index(ISI); is a self-report questionnaire measuring insomnia symptoms to evaluate the degree of insomnia.
The scale consists of seven questions that evaluate Sleep mode , sleep during the night , waking up early , feeling of being rested, how sleeping problems affecting daily life , and how sleep patterns concern the individual
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6 months
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Differences between the three intervention groups regarding change in biomarkers such as proteins , micro - RNA , cytokines, mitochondrial DNA and telomeres
기간: 6 months
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blood samples
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6 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Nymberg P, Ekvall Hansson E, Stenman E, Calling S, Sundquist K, Sundquist J, Zoller B. Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol. Trials. 2018 Oct 17;19(1):563. doi: 10.1186/s13063-018-2932-9.
- Nymberg P, Calling S, Stenman E, Palmer K, Hansson EE, Sundquist K, Sundquist J, Zoller B. Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study. Pilot Feasibility Stud. 2021 Mar 17;7(1):70. doi: 10.1186/s40814-021-00810-6.
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Pny1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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신체 활동에 대한 임상 시험
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University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스
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