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Clinical Trials/NCT05361343
NCT05361343
Recruiting
Not Applicable

First Line Prevent Age Study

Prevent Age Resort "Pervaya Liniya"1 site in 1 country100 target enrollmentFebruary 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Aging
Sponsor
Prevent Age Resort "Pervaya Liniya"
Enrollment
100
Locations
1
Primary Endpoint
Reducing the degree of anxiety
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

To prove the effectiveness of complex wellness programs in terms of maintaining active longevity, including motivational counseling, high-intensity training, intermittent fasting, hypoxic training, as well as practices for achieving healthy sleep and mental well-being.

Clinical-instrumental, single-centre, prospective, open-label, non-randomized, sequential enrollment study with blinded endpoint analysis

Registry
clinicaltrials.gov
Start Date
February 2025
End Date
September 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Prevent Age Resort "Pervaya Liniya"
Responsible Party
Principal Investigator
Principal Investigator

Anna Ratnikova

Cardiologist, MD, PhD, Chief physician, PervayaLiniyaResort, Russia

Saint Petersburg State University, Russia

Eligibility Criteria

Inclusion Criteria

  • Men and women over 18;
  • No significant (affecting the functional state) "active" diseases: acute diseases and exacerbations of chronic diseases;
  • Interest in active longevity and willingness to participate in research.
  • Signed informed consent.

Exclusion Criteria

  • Age up to 18 years;
  • Severe or moderate comorbidities;
  • Rheumatological (systemic / autoimmune) diseases of any severity;
  • Intestinal infections (within 3 months);
  • SARS / pneumonia, other diseases accompanied by systemic inflammation during the last 2 months;
  • Chronic inflammatory bowel disease;
  • Major surgery within the last 3 months
  • Intoxication (alcohol, drugs, other toxins);
  • Oncological disease (except for basalioma) out of remission;
  • Persons with mental illness;

Outcomes

Primary Outcomes

Reducing the degree of anxiety

Time Frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)

Reduction in the degree of anxiety according to the assessment of the Spielberger test

improved endothelial function

Time Frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)

improvement of flow-mediated vasodilatation measured by ultrasound (cuff test)

improved quality of night sleep

Time Frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)

improvement in nighttime sleep quality assessed by a Pittsburgh Sleep Quality Scale

Secondary Outcomes

  • improved quality of night sleep(First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit))
  • increased self-esteem(First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit))

Study Sites (1)

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