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Healthy AgingDO-HEALTH-CNCT05062018

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

An observational study of Healthy Aging, run by Heike Bischoff-Ferrari at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Healthy Aging
How many people
534 participants
Where
1 siteSwitzerland
Study dates
26 Nov 2019to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • Former participation in the DO-HEALTH clinical trial study

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Zurich

Other trials in Switzerland

About this study

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.

Read the 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.

Conditions
Healthy Aging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of functional decline

    assessed by short physical performance test battery

    Measured: 24 months

  2. Incidence of injurious falls

    assessed by fall questionnaire at each visit

    Measured: 24 months

  3. Incidence of high blood pressure

    Standardized blood pressure assessment in sitting position

    Measured: 24 months

  4. Incidence of cognitive decline

    assessed by Montreal Cognitive Assessment (MoCA)

    Measured: 24 months

  5. Incidence of infections

    assessed by infection questionnaire at each visit

    Measured: 24 months

Secondary outcomes (47)

  1. Incidence and prevalence of frailty

    based on criteria by L. Fried (shrinking, weakness, poor endurance and energy, slowness, low physical activity level), SHARE-FI

    Measured: 24 months

  2. Incidence and prevalence of impaired mobility

    assessed by EQ5D-3L, physical activity questionnaire

    Measured: 24 months

  3. Incidence and prevalence of functional dependency

    assessed by PROMIS-HAQ

    Measured: 24 months

  4. Incidence and prevalence of anemia or iron deficiency

    assessed by blood markers (ferritin, soluble transferrin receptor, RBC, Hb, erythrocyte indices (MCV, MCH, MCHC), reticulocytes)

    Measured: 24 months

  5. Incidence and prevalence of any cardiovascular disease

    assessed by medical history

    Measured: 24 months

  6. Incidence and prevalence of heart arrhythmia

    assessed by ECG

    Measured: 24 months

  7. Incidence and prevalence of atrial fibrillation

    assessed by ECG

    Measured: 24 months

  8. Incidence and prevalence of heart failure, cardiomyopathy, heart valves abnormalities

    assessed by medical history, ECG, physical examination

    Measured: 24 months

  9. Incidence of stroke

    assessed by medical history

    Measured: 24 months

  10. Incidence and prevalence of Type 2 diabetes

    assessed by medical history

    Measured: 24 months

  11. Incidence and prevalence of dementia

    assessed by medical history

    Measured: 24 months

  12. Incidence and prevalence of osteoarthritis

    assessed by medical history

    Measured: 24 months

  13. Incidence and prevalence osteoporosis

    assessed by medical history

    Measured: 24 months

  14. Incidence and prevalence of sarcopenia, osteosarcopenia

    assessed by medical history

    Measured: 24 months

  15. Incidence and prevalence of any gastrointestinal disease

    assessed by medical history

    Measured: 24 months

  16. Incidence and prevalence of gastroesophageal reflux disease (GERD)

    assessed by medical history

    Measured: 24 months

  17. Incidence and prevalence of any micronutrient deficiency (Vitamins, Minerals and fatty acids)

    assessed by medical history

    Measured: 24 months

  18. Incidence and prevalence of knee buckling

    assessed by medical history, Buckling, KOOS, HOOS

    Measured: 24 months

  19. Incidence and prevalence of chronic pain

    assessed by medical history, McGill, Joint Map, EQ5D-3L

    Measured: 24 months

  20. Incidence and prevalence of subjective memory complaints

    assessed by medical history, MoCA, MACQ

    Measured: 24 months

  21. Incidence and prevalence of hearing impairment

    assessed by medical history, hearing test, physical examination

    Measured: 24 months

  22. Incidence and prevalence of depression

    assessed by medical history, GDS

    Measured: 24 months

  23. Incidence and prevalence insomnia

    assessed by medical history, Insomnia

    Measured: 24 months

  24. Incidence and prevalence of chronic inflammation

    assessed by medical history, blood marker (e.g. CRP)

    Measured: 24 months

  25. Incidence and prevalence of polypharmacy

    assessed by medication

    Measured: 24 months

  26. Incidence and prevalence of inappropriate medication prescription

    assessed by medication

    Measured: 24 months

  27. Incidence and prevalence of age related morbidity by individual drug use (e.g. Proton-Pump-Inhibitors, anticoagulants, benzodiazepines, antibiotics)

    assessed by medication

    Measured: 24 months

  28. Incidence and prevalence of malnutrition

    assessed by medical history, FFQ, GOHAI, Rome

    Measured: 24 months

  29. Incidence and prevalence of urinary incontinence

    assessed by medical history, IPPS, QUID

    Measured: 24 months

  30. Incidence and prevalence of impaired quality of life

    assessed by EQ5D-3L

    Measured: 24 months

  31. Incidence and prevalence of functional decline

    assessed by medical history

    Measured: 24 months

  32. Incidence of fractures

    assessed by fracture rate

    Measured: 24 months

  33. Incidence of all-cause hospitalization

    assessed by medical history

    Measured: 24 months

  34. Incidence and prevalence of frequent health care utilization

    assessed by medical history

    Measured: 24 months

  35. trajectories of frequent health care utilization

    assessed by medical history

    Measured: 24 months

  36. Incidence of nursing home placement

    assessed by medical history

    Measured: 24 months

  37. Incidence of cancer (any cancer, gastro-intestinal, breast cancer in women, prostate cancer in men)

    assessed by medical history

    Measured: 24 months

  38. Incidence of all-cause mortality

    Measured: 24 months

  39. Prevalence of MIND diet adherence (DO-HEALTHcohort-MINDful substudy)

    assessed by FFQ

    Measured: 24months

  40. Prevalence and Incidence of Mild Cognitive impairment (DO-HEALTHcohort-MINDful substudy)

    assessed by MoCA

    Measured: 24months

  41. Dual-tasking gait variability (DO-HEALTHcohort-MINDful substudy)

    assessed by GAITRite® Platinum (Basel only)

    Measured: one time

  42. Prevalence of confirmed Covid-19 cases (DO-HEALTHcohort-MINDful substudy)

    assessed by medical history

    Measured: 24 months

  43. Prevalence of Covid-19 vaccinated participants (DO-HEALTHcohort-MINDful substudy)

    assessed by medical history

    Measured: 24 months

  44. Prevalence of reported subjective cognitive decline (DO-HEALTHcohort-MINDful substudy)

    assessed by MAC-Q, GDS, EQ5D-3L

    Measured: 24 months

  45. Covid-19 related resilience (DO-HEALTHcohort-MINDful substudy)

    assessed by Brief Resilience Scale (BRS)

    Measured: one time

  46. Covid-19 related stress (DO-HEALTHcohort-MINDful)

    assessed by Covid-19 Pandemic Stress Scale (CPSS)

    Measured: one time

  47. Covid-19 related coping behaviours (DO-HEALTHcohort-MINDful)

    assessed by Pandemic Coping Scale (PCS)

    Measured: one time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2021
  2. Study start26 Nov 2019
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
534 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05062018
Sponsor's protocol ID
2019-00134
Other IDs
2019
Acronym
DO-HEALTH-C
Status last verified
Dec 2022
First submitted
20 Sep 2021
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Aging, run by Heike Bischoff-Ferrari at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of functional decline (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05062018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.

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