Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- Incidence of functional decline
研究概览
简要总结
The DO-HEALTH trial will be extended into the cohort including the collection on life style factors such as diet, quality of life and physical activity, as well as health-related data on co-morbid conditions as well as a standardized assessment of multiple organ functions, physical, cognitive and mental function using surveys and standardized health assessments.
详细描述
The DO-HEALTH cohort will be a continuation of the trial without intervention and will elucidate longterm determinants of healthy, active and independent aging in European community-dwelling older adults. The main emphasize of the cohort will be to determine the risk factors, to quantify the incidence and to describe the trajectories of incident frailty, impaired mobility, loss of independence and age related morbidity (e.g. heart arrhythmia, type 2 diabetes, falls, fractures).
Additionally, the cohort will continue to investigate the primary endpoints of the original trial like the risk and incidence of injurious falls (bone); functional decline (muscle); high blood pressure (cardiovascular); cognitive decline (brain); and the rate of any infection (immunity). Moreover, the cohort will include and extend key secondary and exploratory endpoints of the original trial such as incidence and prevalence of anemia, sarcopenia, cardiovascular diseases, type 2 diabetes and cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Former participation in the DO-HEALTH clinical trial study
排除标准
- •Inability or unwillingness to give written informed consent
- •Medical condition that would make the results of the tests/assessments unreliable and/or would put too much burden to the participant, and/or leads to safety concerns.
结局指标
主要结局
Incidence of functional decline
时间窗: 24 months
assessed by short physical performance test battery
Incidence of injurious falls
时间窗: 24 months
assessed by fall questionnaire at each visit
Incidence of cognitive decline
时间窗: 24 months
assessed by Montreal Cognitive Assessment (MoCA)
Incidence of infections
时间窗: 24 months
assessed by infection questionnaire at each visit
Incidence of high blood pressure
时间窗: 24 months
Standardized blood pressure assessment in sitting position
次要结局
- Incidence and prevalence of atrial fibrillation(24 months)
- Incidence and prevalence of dementia(24 months)
- Incidence and prevalence of any gastrointestinal disease(24 months)
- Incidence and prevalence of gastroesophageal reflux disease (GERD)(24 months)
- Incidence and prevalence of inappropriate medication prescription(24 months)
- Incidence and prevalence of malnutrition(24 months)
- trajectories of frequent health care utilization(24 months)
- Incidence of stroke(24 months)
- Incidence and prevalence of Type 2 diabetes(24 months)
- Incidence and prevalence osteoporosis(24 months)
- Incidence and prevalence of chronic pain(24 months)
- Incidence and prevalence of urinary incontinence(24 months)
- Incidence and prevalence of impaired quality of life(24 months)
- Incidence and prevalence of functional decline(24 months)
- Incidence of fractures(24 months)
- Dual-tasking gait variability (DO-HEALTHcohort-MINDful substudy)(one time)
- Covid-19 related stress (DO-HEALTHcohort-MINDful)(one time)
- Incidence and prevalence of frailty(24 months)
- Incidence and prevalence of impaired mobility(24 months)
- Incidence and prevalence of anemia or iron deficiency(24 months)
- Incidence and prevalence of heart failure, cardiomyopathy, heart valves abnormalities(24 months)
- Incidence and prevalence of any micronutrient deficiency (Vitamins, Minerals and fatty acids)(24 months)
- Incidence and prevalence of subjective memory complaints(24 months)
- Incidence and prevalence of hearing impairment(24 months)
- Incidence and prevalence insomnia(24 months)
- Incidence and prevalence of chronic inflammation(24 months)
- Incidence and prevalence of polypharmacy(24 months)
- Incidence and prevalence of age related morbidity by individual drug use (e.g. Proton-Pump-Inhibitors, anticoagulants, benzodiazepines, antibiotics)(24 months)
- Prevalence of MIND diet adherence (DO-HEALTHcohort-MINDful substudy)(24months)
- Prevalence of Covid-19 vaccinated participants (DO-HEALTHcohort-MINDful substudy)(24 months)
- Prevalence of reported subjective cognitive decline (DO-HEALTHcohort-MINDful substudy)(24 months)
- Covid-19 related resilience (DO-HEALTHcohort-MINDful substudy)(one time)
- Covid-19 related coping behaviours (DO-HEALTHcohort-MINDful)(one time)
- Incidence and prevalence of functional dependency(24 months)
- Incidence and prevalence of any cardiovascular disease(24 months)
- Incidence and prevalence of heart arrhythmia(24 months)
- Incidence and prevalence of osteoarthritis(24 months)
- Incidence and prevalence of sarcopenia, osteosarcopenia(24 months)
- Incidence and prevalence of knee buckling(24 months)
- Incidence and prevalence of depression(24 months)
- Incidence and prevalence of frequent health care utilization(24 months)
- Incidence of all-cause mortality(24 months)
- Prevalence and Incidence of Mild Cognitive impairment (DO-HEALTHcohort-MINDful substudy)(24months)
- Prevalence of confirmed Covid-19 cases (DO-HEALTHcohort-MINDful substudy)(24 months)
- Incidence of all-cause hospitalization(24 months)
- Incidence of nursing home placement(24 months)
- Incidence of cancer (any cancer, gastro-intestinal, breast cancer in women, prostate cancer in men)(24 months)
研究者
Heike Bischoff-Ferrari
Prof. Dr. med. DrPH
University of Zurich