NCT06866301

Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study

DiANa Project: Uncovering the Relationship Between MircroRNA Expression, Gut Microbiota and Prognosis in Patients with Anorexia Nervosa.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Oviedo · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to perform a comprehensive analysis of varied health markers and analyze the impact of lifestyle interventions on the prognosis of anorexia nervosa (AN) patients. In addition, this study aims to determine if biomarker analysis can be used as clinical outcomes for disease prognosis long-term and support individualized treatment strategies in female patients with AN during the post-hospitalization phase. The main questions it aims to answer are: * What are the miRs and microbiota profiles associated with AN, and how are they linked to other clinical markers? * How does a lifestyle intervention (exercise with nutritional support) affect biomarkers and clinical markers during the first three months after hospitalization? * What are the dynamics and associations of biomarkers, including gut microbiota, and how do they relate to critical events during the six months after hospitalization? * What is the perceived effect of participating in a healthy lifestyle program for patients, families, and professionals involved in the care of these patients? Participants will: * Undergo analysis of biomarkers and gut microbiota associated with AN. * Participate in a lifestyle intervention program involving exercise during the first three months post-hospitalization. * Provide samples for biomarker and gut microbiota mapping over a six-month period. * Share feedback on their perceived experience in the lifestyle program through interviews or surveys. Researchers will compare biomarker and gut microbiota and the effects of the intervention to determine if a lifestyle exercise intervention can lead to better outcomes, and analyze its potential to individualized care strategies.

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
BEHAVIORAL	Progressive Resistance Exercise	The exercise program will have a duration of 10 weeks. It will be divided in two phases: conditioning phase and training phase. During the conditioning phase (2-3 weeks), participants will learn exercise techniques, work on their interoceptive awareness and perform same exercises at a lower intensity to prepare the muscles for the next phase. In the training phase, the intensity will be moderate starting at approximately 60% of capacity, with a frequency of three days per week and continuous adjustment (progression) based on the participant's improvements. Each session will include a warm-up and cool-down of approximately 10 minutes. The central part of the session will be in the form of a circuit and will include 6 large muscle group exercises using a combination of machine exercises following the PPL (push, pull and legs) model and 3 core strengthening exercises.

Timeline

• Start date: 2022-05-25
• Primary completion: 2025-07-01
• Completion: 2025-11-30
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: Spain