First Line Prevent Age Study

Not Applicable

Recruiting

• Conditions: Healthy Lifestyle; Healthy Aging; Healthy Diet
• Interventions: Other: 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement

• Registration Number: NCT05361343
• Lead Sponsor: Prevent Age Resort "Pervaya Liniya"

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Study Start: 2025-02
• Primary Completion: 2026-08
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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;
• Diabetes;
• Syndrome of obstructive sleep apnea of moderate and severe severity;
• Low adherence to lifestyle interventions, including physical activity of less than 150 minutes of aerobic activity per week (at least two days per week) or 75 minutes of vigorous exercise (at least 3 days per week).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement	1. Nutrition: intermittent fasting; 2. Physical activity: medium-intensity or high-intensity physical activity; 3. Hypoxic training (at least three per visit to the center); 4. correction of hygiene and sleep duration, relaxation techniques, cognitive behavioral therapy for insomnia. 5. Individual motivational counseling.

Primary Outcome Measures

Name	Time	Method
Reducing the degree of anxiety	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	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	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 Outcome Measures

Name	Time	Method
improved quality of night sleep	First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)	improvement in nighttime sleep quality assessed by a sleep indicator scale
increased self-esteem	First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)	increasing the level of self-esteem based on the results of the analysis of the Dembo-Rubinstein questionnaire

Trial Locations

Locations (1)

First Line Health Care Resort; 🇷🇺 Saint Petersburg, Russian Federation