First Line Prevent Age Study

NCT ID: NCT05361343

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-09-30

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

Conditions

Healthy Aging; Healthy Lifestyle; Healthy Diet

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1

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.

Group Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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;
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prevent Age Resort "Pervaya Liniya"

OTHER

Sponsor Role: lead

Responsible Party

Anna Ratnikova

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Line Health Care Resort

Saint Petersburg, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Anna Ratnikova

Role: CONTACT

ya.ashikhmin@gmail.com

+7 921 303-15-33

Facility Contacts

Anna Ratnikova

Role: primary

a.ratnikova@hcresort.ru

+7 921 303-15-33

Other Identifiers

FLIPS-1

Identifier Type: -

Identifier Source: org_study_id