Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort (DO-HEALTH-C)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Aging

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.

• Study Type: Observational
• Enrollment (Anticipated): 534

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Centre on Aging and Mobility, University of Zurich, City Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The DO-HEALTH Cohort includes the population of the former DO-HEALTH clinical trial (NCT01745263)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of functional decline	assessed by short physical performance test battery	24 months
Incidence of injurious falls	assessed by fall questionnaire at each visit	24 months
Incidence of high blood pressure	Standardized blood pressure assessment in sitting position	24 months
Incidence of cognitive decline	assessed by Montreal Cognitive Assessment (MoCA)	24 months
Incidence of infections	assessed by infection questionnaire at each visit	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence and prevalence of impaired mobility	assessed by EQ5D-3L, physical activity questionnaire	24 months
Incidence and prevalence of functional dependency	assessed by PROMIS-HAQ	24 months
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
Incidence and prevalence of any cardiovascular disease	assessed by medical history	24 months
Incidence and prevalence of heart arrhythmia	assessed by ECG	24 months
Incidence and prevalence of atrial fibrillation	assessed by ECG	24 months
Incidence and prevalence of heart failure, cardiomyopathy, heart valves abnormalities	assessed by medical history, ECG, physical examination	24 months
Incidence of stroke	assessed by medical history	24 months
Incidence and prevalence of Type 2 diabetes	assessed by medical history	24 months
Incidence and prevalence of dementia	assessed by medical history	24 months
Incidence and prevalence of osteoarthritis	assessed by medical history	24 months
Incidence and prevalence osteoporosis	assessed by medical history	24 months
Incidence and prevalence of sarcopenia, osteosarcopenia	assessed by medical history	24 months
Incidence and prevalence of any gastrointestinal disease	assessed by medical history	24 months
Incidence and prevalence of gastroesophageal reflux disease (GERD)	assessed by medical history	24 months
Incidence and prevalence of any micronutrient deficiency (Vitamins, Minerals and fatty acids)	assessed by medical history	24 months
Incidence and prevalence of knee buckling	assessed by medical history, Buckling, KOOS, HOOS	24 months
Incidence and prevalence of chronic pain	assessed by medical history, McGill, Joint Map, EQ5D-3L	24 months
Incidence and prevalence of subjective memory complaints	assessed by medical history, MoCA, MACQ	24 months
Incidence and prevalence of hearing impairment	assessed by medical history, hearing test, physical examination	24 months
Incidence and prevalence of depression	assessed by medical history, GDS	24 months
Incidence and prevalence insomnia	assessed by medical history, Insomnia	24 months
Incidence and prevalence of chronic inflammation	assessed by medical history, blood marker (e.g. CRP)	24 months
Incidence and prevalence of polypharmacy	assessed by medication	24 months
Incidence and prevalence of inappropriate medication prescription	assessed by medication	24 months
Incidence and prevalence of age related morbidity by individual drug use (e.g. Proton-Pump-Inhibitors, anticoagulants, benzodiazepines, antibiotics)	assessed by medication	24 months
Incidence and prevalence of malnutrition	assessed by medical history, FFQ, GOHAI, Rome	24 months
Incidence and prevalence of urinary incontinence	assessed by medical history, IPPS, QUID	24 months
Incidence and prevalence of impaired quality of life	assessed by EQ5D-3L	24 months
Incidence and prevalence of functional decline	assessed by medical history	24 months
Incidence of fractures	assessed by fracture rate	24 months
Incidence of all-cause hospitalization	assessed by medical history	24 months
Incidence and prevalence of frequent health care utilization	assessed by medical history	24 months
trajectories of frequent health care utilization	assessed by medical history	24 months
Incidence of nursing home placement	assessed by medical history	24 months
Incidence of cancer (any cancer, gastro-intestinal, breast cancer in women, prostate cancer in men)	assessed by medical history	24 months
Incidence of all-cause mortality		24 months
Prevalence of MIND diet adherence (DO-HEALTHcohort-MINDful substudy)	assessed by FFQ	24months
Prevalence and Incidence of Mild Cognitive impairment (DO-HEALTHcohort-MINDful substudy)	assessed by MoCA	24months
Dual-tasking gait variability (DO-HEALTHcohort-MINDful substudy)	assessed by GAITRite® Platinum (Basel only)	one time
Prevalence of confirmed Covid-19 cases (DO-HEALTHcohort-MINDful substudy)	assessed by medical history	24 months
Prevalence of Covid-19 vaccinated participants (DO-HEALTHcohort-MINDful substudy)	assessed by medical history	24 months
Prevalence of reported subjective cognitive decline (DO-HEALTHcohort-MINDful substudy)	assessed by MAC-Q, GDS, EQ5D-3L	24 months
Covid-19 related resilience (DO-HEALTHcohort-MINDful substudy)	assessed by Brief Resilience Scale (BRS)	one time
Covid-19 related stress (DO-HEALTHcohort-MINDful)	assessed by Covid-19 Pandemic Stress Scale (CPSS)	one time
Covid-19 related coping behaviours (DO-HEALTHcohort-MINDful)	assessed by Pandemic Coping Scale (PCS)	one time

Collaborators and Investigators

• Sponsor: Heike Bischoff-Ferrari
• Investigators: Principal Investigator: Heike Bischoff-Ferrari, Prof. Dr. med. DrPH, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019-00134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No