NCT05256199进行中（未招募）不适用
Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
Alzheimercentrum Amsterdam6 个研究点 分布在 1 个国家目标入组 1,210 人开始时间: 2022年2月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,210
- 试验地点
- 6
- 主要终点
- 2-year change from baseline in global cognitive composite score
研究概览
简要总结
FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60-79 years of age at pre-screening;
- •Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
- •Providing informed consent to all study procedures;
- •Internet access at home;
- •Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).
排除标准
- •Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
- •Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score<23);
- •Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
- •Coincident participation in any other intervention trial at time of pre-screening.
- •Coincident participation of spouse in FINGER-NL trial.
研究组 & 干预措施
low-intensity group
No Intervention
The low-intensity arm receives online access to general lifestyle-related health information.
high-intensity group
Experimental
The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions.
干预措施: Multidomain lifestyle intervention (Behavioral)
结局指标
主要结局
2-year change from baseline in global cognitive composite score
时间窗: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall (discrete number; 0-15 (higher score means a better outcome)), Digit Symbol Substitution Test 90 seconds (discrete number; 0-90 (higher score means a better outcome)), WAIS digit span backwards (discrete number; 0-14 (higher score means a better outcome)), and semantic fluency (discrete number; 0-no maximum, higher score means a better outcome)).
次要结局
- 15-Word Verbal Learning Test delayed recall(2 years (measured at baseline, follow-up 1 and follow-up 2))
- LASA Sedentary Behavior Questionnaire(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Wechsler Adult Intelligence Scale (WAIS) digit span backwards(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Semantic fluency(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Aβ42/40 ratio(2 years (measured at baseline and follow-up 2))
- Digit Symbol Substitution Test 90 seconds(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)(2 years (measured at baseline, follow-up 1 and follow-up 2))
- 5 level EuroQol-5D (EQ-5D-5L)(2 years (measured at baseline, follow-up 1 and follow-up 2))
- LIfestyle for BRAin health (LIBRA)(2 years (measured at baseline, follow-up 1 and follow-up 2))
- grip strength test(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Blood pressure(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Cholesterol(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Blood glucose(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Hip circumference(2 years (measured at baseline, follow-up 1 and follow-up 2))
- SQUASH questionnaire(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Pittsburgh Fatigability Scale(2 years (measured at baseline, follow-up 1 and follow-up 2))
- SARC-F Sarcopenia Questionnaire(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Perceived Stress Scale(2 years (measured at baseline, follow-up 1 and follow-up 2))
- MetaMemory in Adulthood (MIA)(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Waist circumference(2 years (measured at baseline, follow-up 1 and follow-up 2))
- MIND-adjusted Eetscore-FFQ(2 years (measured at baseline, follow-up 1 and follow-up 2))
- De Jong Gierveldt Loneliness Scale(2 years (measured at baseline and follow-up 2))
- Actigraph (Groningen site only)(2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2))
- Physical Activity Record questionnaire (Groningen site only)(2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2))
- Height(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Weight(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Hill-Bone Medication Adherence Scale(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Nutritional intake(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Pittsburg Sleep Quality Index(2 years (measured at baseline, follow-up 1 and follow-up 2))
- Insomnia severity index(2 years (measured at baseline, follow-up 1 and follow-up 2))
- p-tau(2 years (measured at baseline and follow-up 2))
- NfL(2 years (measured at baseline and follow-up 2))
- GFAP(2 years (measured at baseline and follow-up 2))
- Lubben Social Network Scale(2 years (measured at baseline, follow-up 1 and follow-up 2))
- BDNF(2 years (measured at baseline and follow-up 2))
研究者
Marissa Zwan
PI
Amsterdam UMC, location VUmc
研究点 (6)
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