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

NCT05815732 | Unknown

• 1 other identifier: HEBE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Aging

Keywords

chronic inflammation; physical exercise; lifestyle; prevention

Outcome Measures

Primary Outcomes (1)

• Change in maximal oxygen consumption (VO2 max)

  The maximum or optimum rate at which the heart, lungs, and muscles can effectively use oxygen during exercise, used as a way of measuring a person's individual aerobic capacity.

  Change from baseline VO2 max at six months

Study Arms (1)

Physical exercise prescription

EXPERIMENTAL

Prescription of a personalized exercise program, which will define modalities, intensity, duration, frequency and progression of the exercise. For each subject, at baseline and after 6 months, biological samples will be collected (blood, urine, saliva and nasal swab)

Other: Physical exercise

Interventions

Physical exercise OTHER

Personalized exercise program, with defined modalities, intensity, duration, frequency and progression of the exercise.

Physical exercise prescription

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being an employee of UMilan of both sexes and of any age (18-70 years);
• For the 100 chosen subjects identified for Phase 2: declare that they do not carry out physical activities at a competitive level and that you are committed about improving your own lifestyle.

You may not qualify if:

• Previous myocardial infarction
• Autoimmune diseases
• Neurodegenerative pathologies
• Psychiatric pathologies
• Cardiac arrhythmias
• Chronic obstructive pulmonary disease
• osteo-muscular problems that prevent the execution of physical activity;
• oncological pathologies in the last 3 years that have required chemotherapy or immunotherapy;
• pregnancy/nursing/intention to become pregnant.

Sponsors & Collaborators

• University of Milan: lead
• Istituto Auxologico Italiano: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

University of Milan

Milan, 20122, Italy

Location

Related Publications (1)

• Bianchi F, Biganzoli EM, Bollati V, Clerici M, Lucini D, Mando C, Rota F; HEBE Consortium. 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. PLoS One. 2024 Apr 30;19(4):e0300011. doi: 10.1371/journal.pone.0300011. eCollection 2024.

  PMID: 38687742 DERIVED

Related Links

• HEBE project website

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elia M Biganzoli, PhD

  University of Milan

  STUDY DIRECTOR

• Daniela Lucini, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

• Valentina Bollati, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

• Francesca Bianchi, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

• Chiara Mandò, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

• Mario Clerici, PhD

  University of Milan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Medical Statistics

Model Details: Participants will be assessed before and after the intervention with physical exercise and personalized lifestyle advice.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 18, 2023
• Study Start: November 8, 2022
• Primary Completion: February 22, 2023
• Study Completion: July 20, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

IT (1)