Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort
- Conditions
- Healthy Aging
- Registration Number
- NCT05062018
- Lead Sponsor
- Heike Bischoff-Ferrari
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 534
- Former participation in the DO-HEALTH clinical trial study
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of functional decline 24 months assessed by short physical performance test battery
Incidence of injurious falls 24 months assessed by fall questionnaire at each visit
Incidence of cognitive decline 24 months assessed by Montreal Cognitive Assessment (MoCA)
Incidence of infections 24 months assessed by infection questionnaire at each visit
Incidence of high blood pressure 24 months Standardized blood pressure assessment in sitting position
- Secondary Outcome Measures
Name Time Method Incidence and prevalence of dementia 24 months assessed by medical history
Incidence and prevalence of any gastrointestinal disease 24 months assessed by medical history
Incidence and prevalence of gastroesophageal reflux disease (GERD) 24 months assessed by medical history
Incidence and prevalence of inappropriate medication prescription 24 months assessed by medication
Incidence and prevalence of malnutrition 24 months assessed by medical history, FFQ, GOHAI, Rome
trajectories of frequent health care utilization 24 months assessed by medical history
Incidence and prevalence of impaired quality of life 24 months assessed by EQ5D-3L
Incidence and prevalence of functional decline 24 months assessed by medical history
Incidence of fractures 24 months assessed by fracture rate
Dual-tasking gait variability (DO-HEALTHcohort-MINDful substudy) one time assessed by GAITRite® Platinum (Basel only)
Covid-19 related stress (DO-HEALTHcohort-MINDful) one time assessed by Covid-19 Pandemic Stress Scale (CPSS)
Incidence and prevalence of atrial fibrillation 24 months assessed by ECG
Incidence of stroke 24 months assessed by medical history
Incidence and prevalence of Type 2 diabetes 24 months assessed by medical history
Incidence and prevalence osteoporosis 24 months assessed by medical history
Incidence and prevalence of chronic pain 24 months assessed by medical history, McGill, Joint Map, EQ5D-3L
Incidence and prevalence of urinary incontinence 24 months assessed by medical history, IPPS, QUID
Incidence and prevalence of frailty 24 months based on criteria by L. Fried (shrinking, weakness, poor endurance and energy, slowness, low physical activity level), SHARE-FI
Incidence and prevalence of impaired mobility 24 months assessed by EQ5D-3L, physical activity questionnaire
Incidence and prevalence of anemia or iron deficiency 24 months assessed by blood markers (ferritin, soluble transferrin receptor, RBC, Hb, erythrocyte indices (MCV, MCH, MCHC), reticulocytes)
Incidence and prevalence of heart failure, cardiomyopathy, heart valves abnormalities 24 months assessed by medical history, ECG, physical examination
Incidence and prevalence of any micronutrient deficiency (Vitamins, Minerals and fatty acids) 24 months assessed by medical history
Incidence and prevalence of subjective memory complaints 24 months assessed by medical history, MoCA, MACQ
Incidence and prevalence of hearing impairment 24 months assessed by medical history, hearing test, physical examination
Incidence and prevalence insomnia 24 months assessed by medical history, Insomnia
Incidence and prevalence of chronic inflammation 24 months assessed by medical history, blood marker (e.g. CRP)
Incidence and prevalence of polypharmacy 24 months assessed by medication
Incidence and prevalence of age related morbidity by individual drug use (e.g. Proton-Pump-Inhibitors, anticoagulants, benzodiazepines, antibiotics) 24 months assessed by medication
Prevalence of MIND diet adherence (DO-HEALTHcohort-MINDful substudy) 24months assessed by FFQ
Prevalence of Covid-19 vaccinated participants (DO-HEALTHcohort-MINDful substudy) 24 months assessed by medical history
Prevalence of reported subjective cognitive decline (DO-HEALTHcohort-MINDful substudy) 24 months assessed by MAC-Q, GDS, EQ5D-3L
Covid-19 related resilience (DO-HEALTHcohort-MINDful substudy) one time assessed by Brief Resilience Scale (BRS)
Covid-19 related coping behaviours (DO-HEALTHcohort-MINDful) one time assessed by Pandemic Coping Scale (PCS)
Incidence and prevalence of functional dependency 24 months assessed by PROMIS-HAQ
Incidence and prevalence of any cardiovascular disease 24 months assessed by medical history
Incidence and prevalence of heart arrhythmia 24 months assessed by ECG
Incidence and prevalence of osteoarthritis 24 months assessed by medical history
Incidence and prevalence of sarcopenia, osteosarcopenia 24 months assessed by medical history
Incidence and prevalence of knee buckling 24 months assessed by medical history, Buckling, KOOS, HOOS
Incidence and prevalence of depression 24 months assessed by medical history, GDS
Incidence and prevalence of frequent health care utilization 24 months assessed by medical history
Incidence of all-cause mortality 24 months Prevalence and Incidence of Mild Cognitive impairment (DO-HEALTHcohort-MINDful substudy) 24months assessed by MoCA
Prevalence of confirmed Covid-19 cases (DO-HEALTHcohort-MINDful substudy) 24 months assessed by medical history
Incidence of all-cause hospitalization 24 months assessed by medical history
Incidence of nursing home placement 24 months assessed by medical history
Incidence of cancer (any cancer, gastro-intestinal, breast cancer in women, prostate cancer in men) 24 months assessed by medical history
Trial Locations
- Locations (1)
Centre on Aging and Mobility, University of Zurich, City Hospital Zurich
🇨🇭Zürich, Switzerland