NCT05815732: HEBE

HEBE Project - Healthy Aging Versus Inflamm-aging: the Role of Physical Exercise in Modulating the Biomarkers of Age-associated and Environmentally Determined Chronic Diseases

Status unknown NA Last updated 18 April 2023

What this trial tests

NA trial testing Physical exercise in Aging in 100 participants. Status unknown.

Timeline

8 November 2022

Primary endpoint
22 February 2023

20 July 2023

Quick facts

Lead sponsor	University of Milan
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	8 November 2022
Primary completion	22 February 2023
Estimated completion	20 July 2023
Sites	1 location across Italy

Drugs / interventions tested

• Physical exercise

Conditions studied

• Aging — all drugs for Aging →

Sponsor

University of Milan

Who can join

Adults 18 to 70, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of this clinical trial is to test the effects of the personalized intervention based on physical exercise, on clinical variables and circulating markers, in a population of employees of the University of Milan (UMilan).

The HEBE study will include two phases:

PHASE 1:

All UMilan employees will be asked to voluntarily complete an anonymous online questionnaire, in order to gather information about their lifestyle (physical activity, diet, cigarette smoking, etc) (zero time: T0); at the end of the compilation, indications on how to improve the lifestyle will be provided. These indications will also be present and available for consultation in a special section of the site on the "HEBE" site, with UMilan domain (www.hebe.unimi.it).

After 6 months, all UMilan employees will receive a second invitation to voluntarily complete the same questionnaire, in order to evaluate any changes, in terms of lifestyle improvement (time one: T1).

PHASE 2:

100 eligible subjects who have expressed their availability in the initial questionnaire, will be identified to undergo a lifestyle improvement protocol based mainly on the prescription of a personalized exercise program, which will define modalities, intensity, duration, frequency and progression of the exercise. For each subject, at T0 and T1 (after 6 months), biological samples will be collected (blood, urine, saliva and nasal swab), which will be used to: i) set up a biobank shared by the members of the HEBE consortium; ii) identify biomarkers able to monitor the effect of physical exercise on the characteristics of the frailty under examination. Furthermore, both at T0 and T1 questionnaires will be completed and carried out clinical evaluations (anamnesis, physical examination, tests for the study of the autonomic nervous system, bio-impedance test, evaluation/estimate of maximal oxygen consumption, ECG).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. HEBE project: Healthy aging versus inflamm-aging: The role of physical exercise in modulating the biomarkers of age-associated and environmentally determined chronic diseases, study protocol.
   Bianchi F, Biganzoli EM, Bollati V, Clerici M, et al · · 2024 · PMID 38687742 · DOI 10.1371/journal.pone.0300011
2. HEBE Project: Healthy aging versus inflamm-aging: the role of physical Exercise in modulating the Biomarkers of age-associated and Environmentally determined chronic diseases, Study Protocol.
   Bianchi F, Biganzoli EM, Bollati V, Clerici M, et al · · 2023 · DOI 10.21203/rs.3.rs-3206429/v1