Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort

Healthy Aging Clinical Trial

— DO-HEALTH-C  

Official title:

Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05062018
• Other study ID #: 2019-00134
• Status: Enrolling by invitation
• Start date: November 26, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 534
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Former participation in the DO-HEALTH clinical trial study

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy Aging

Locations

Country	Name	City	State
Switzerland	Centre on Aging and Mobility, University of Zurich, City Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Heike Bischoff-Ferrari

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of functional decline	assessed by short physical performance test battery	24 months
Primary	Incidence of injurious falls	assessed by fall questionnaire at each visit	24 months
Primary	Incidence of high blood pressure	Standardized blood pressure assessment in sitting position	24 months
Primary	Incidence of cognitive decline	assessed by Montreal Cognitive Assessment (MoCA)	24 months
Primary	Incidence of infections	assessed by infection questionnaire at each visit	24 months
Secondary	Incidence and prevalence of frailty	based on criteria by L. Fried (shrinking, weakness, poor endurance and energy, slowness, low physical activity level), SHARE-FI	24 months
Secondary	Incidence and prevalence of impaired mobility	assessed by EQ5D-3L, physical activity questionnaire	24 months
Secondary	Incidence and prevalence of functional dependency	assessed by PROMIS-HAQ	24 months
Secondary	Incidence and prevalence of anemia or iron deficiency	assessed by blood markers (ferritin, soluble transferrin receptor, RBC, Hb, erythrocyte indices (MCV, MCH, MCHC), reticulocytes)	24 months
Secondary	Incidence and prevalence of any cardiovascular disease	assessed by medical history	24 months
Secondary	Incidence and prevalence of heart arrhythmia	assessed by ECG	24 months
Secondary	Incidence and prevalence of atrial fibrillation	assessed by ECG	24 months
Secondary	Incidence and prevalence of heart failure, cardiomyopathy, heart valves abnormalities	assessed by medical history, ECG, physical examination	24 months
Secondary	Incidence of stroke	assessed by medical history	24 months
Secondary	Incidence and prevalence of Type 2 diabetes	assessed by medical history	24 months
Secondary	Incidence and prevalence of dementia	assessed by medical history	24 months
Secondary	Incidence and prevalence of osteoarthritis	assessed by medical history	24 months
Secondary	Incidence and prevalence osteoporosis	assessed by medical history	24 months
Secondary	Incidence and prevalence of sarcopenia, osteosarcopenia	assessed by medical history	24 months
Secondary	Incidence and prevalence of any gastrointestinal disease	assessed by medical history	24 months
Secondary	Incidence and prevalence of gastroesophageal reflux disease (GERD)	assessed by medical history	24 months
Secondary	Incidence and prevalence of any micronutrient deficiency (Vitamins, Minerals and fatty acids)	assessed by medical history	24 months
Secondary	Incidence and prevalence of knee buckling	assessed by medical history, Buckling, KOOS, HOOS	24 months
Secondary	Incidence and prevalence of chronic pain	assessed by medical history, McGill, Joint Map, EQ5D-3L	24 months
Secondary	Incidence and prevalence of subjective memory complaints	assessed by medical history, MoCA, MACQ	24 months
Secondary	Incidence and prevalence of hearing impairment	assessed by medical history, hearing test, physical examination	24 months
Secondary	Incidence and prevalence of depression	assessed by medical history, GDS	24 months
Secondary	Incidence and prevalence insomnia	assessed by medical history, Insomnia	24 months
Secondary	Incidence and prevalence of chronic inflammation	assessed by medical history, blood marker (e.g. CRP)	24 months
Secondary	Incidence and prevalence of polypharmacy	assessed by medication	24 months
Secondary	Incidence and prevalence of inappropriate medication prescription	assessed by medication	24 months
Secondary	Incidence and prevalence of age related morbidity by individual drug use (e.g. Proton-Pump-Inhibitors, anticoagulants, benzodiazepines, antibiotics)	assessed by medication	24 months
Secondary	Incidence and prevalence of malnutrition	assessed by medical history, FFQ, GOHAI, Rome	24 months
Secondary	Incidence and prevalence of urinary incontinence	assessed by medical history, IPPS, QUID	24 months
Secondary	Incidence and prevalence of impaired quality of life	assessed by EQ5D-3L	24 months
Secondary	Incidence and prevalence of functional decline	assessed by medical history	24 months
Secondary	Incidence of fractures	assessed by fracture rate	24 months
Secondary	Incidence of all-cause hospitalization	assessed by medical history	24 months
Secondary	Incidence and prevalence of frequent health care utilization	assessed by medical history	24 months
Secondary	trajectories of frequent health care utilization	assessed by medical history	24 months
Secondary	Incidence of nursing home placement	assessed by medical history	24 months
Secondary	Incidence of cancer (any cancer, gastro-intestinal, breast cancer in women, prostate cancer in men)	assessed by medical history	24 months
Secondary	Incidence of all-cause mortality		24 months
Secondary	Prevalence of MIND diet adherence (DO-HEALTHcohort-MINDful substudy)	assessed by FFQ	24months
Secondary	Prevalence and Incidence of Mild Cognitive impairment (DO-HEALTHcohort-MINDful substudy)	assessed by MoCA	24months
Secondary	Dual-tasking gait variability (DO-HEALTHcohort-MINDful substudy)	assessed by GAITRite® Platinum (Basel only)	one time
Secondary	Prevalence of confirmed Covid-19 cases (DO-HEALTHcohort-MINDful substudy)	assessed by medical history	24 months
Secondary	Prevalence of Covid-19 vaccinated participants (DO-HEALTHcohort-MINDful substudy)	assessed by medical history	24 months
Secondary	Prevalence of reported subjective cognitive decline (DO-HEALTHcohort-MINDful substudy)	assessed by MAC-Q, GDS, EQ5D-3L	24 months
Secondary	Covid-19 related resilience (DO-HEALTHcohort-MINDful substudy)	assessed by Brief Resilience Scale (BRS)	one time
Secondary	Covid-19 related stress (DO-HEALTHcohort-MINDful)	assessed by Covid-19 Pandemic Stress Scale (CPSS)	one time
Secondary	Covid-19 related coping behaviours (DO-HEALTHcohort-MINDful)	assessed by Pandemic Coping Scale (PCS)	one time