First Line Prevent Age Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPrevent Age Resort "Pervaya Liniya"
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Age up to 18 years;
Severe or moderate comorbidities;
Rheumatological (systemic / autoimmune) diseases of any severity;
Intestinal infections (within 3 months);
Trial design
Design model
Single group
Treatments tested in this trial
1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement
Other intervention1. 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Arm 1Other 1 intervention
Trial outcomes
Primary outcomes
1
improved endothelial function
improvement of flow-mediated vasodilatation measured by ultrasound (cuff test)
Time frame
First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)2
improved quality of night sleep
improvement in nighttime sleep quality assessed by a Pittsburgh Sleep Quality Scale
Time frame
First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)3
Reducing the degree of anxiety
Reduction in the degree of anxiety according to the assessment of the Spielberger test
Time frame
First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)Secondary outcomes
1
increased self-esteem
increasing the level of self-esteem based on the results of the analysis of the Dembo-Rubinstein questionnaire
Time frame
First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)2
improved quality of night sleep
improvement in nighttime sleep quality assessed by a sleep indicator scale
Time frame
First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Prevent Age Resort "Pervaya Liniya"
Lead sponsor
Saint Petersburg State University, Russia
Sponsor institution
Source ClinicalTrials.gov