First Line Prevent Age Study

Study Overview
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Brief Summary
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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

Official Title
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First Line Prevent Age Study

Conditions
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Healthy Aging, Healthy Lifestyle, Healthy Diet

Intervention / Treatment
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* Other: 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved endothelial function | improvement of flow-mediated vasodilatation measured by ultrasound (cuff test) | First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit) | 
| improved quality of night sleep | improvement in nighttime sleep quality assessed by a Pittsburgh Sleep Quality Scale | First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit) | 
| Reducing the degree of anxiety | Reduction in the degree of anxiety according to the assessment of the Spielberger test | First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit) | 

Secondary Outcome Measures

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