First Line Prevent Age Study

Healthy Aging Clinical Trial

— FLIPS  

Official title:

First Line Prevent Age Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361343
• Other study ID #: FLIPS-1
• Status: Recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Prevent Age Resort "Pervaya Liniya"
• Contact: Anna Ratnikova
• Phone: +7 921 303-15-33
• Email: ya.ashikhmin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Aging
• Healthy Diet
• Healthy Lifestyle

Intervention

Other:
• 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement
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.

Locations

Country	Name	City	State
Russian Federation	First Line Health Care Resort	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Prevent Age Resort "Pervaya Liniya"

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)