Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study
NCT ID: NCT06866301
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
48 participants
INTERVENTIONAL
2022-05-25
2025-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AN-Intervention
Patient enrolled in the exercise intervention group
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.
AN-Control
Patient enrolled in the non-exercise group
No interventions assigned to this group
H-Control
Healthy controls in the non-exercise group
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients with a diagnosis of AN (any subtype)
* BMI \>14kg/m2
* Under treatment at the Regional Eating Disorders Unit at the Area IV and V of the Principality of Asturias
* After acute treatment (total or partial hospitalization or other acute treatment regime following the recommendation of the medical team)
B) Healthy Controls:
\- Meet the physical activity recommendations of the World Health Organization for the age group and sex.
Exclusion Criteria
* Contraindications to perform the evaluations proposed in this project
* Unmanaged dysfunctional or compulsive exercise
* Other criteria that, in the opinion of the medical team, prioritize the patient's health (i.e., psychological instability, substance abuse) .
B) Healthy Controls:
* Suffer from metabolic, pulmonary or cardiovascular disease
* Suffer from serious organic disease
* Taking prescribed medications while participating in the project
* Have contraindications to perform the proposed assessments or intervention.
14 Years
ALL
Yes
Sponsors
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University of Oviedo
OTHER
Responsible Party
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Locations
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University of Oviedo
Oviedo, Principality of Asturias, Spain
Countries
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Other Identifiers
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SV-PA-21-AYUD/2021/58376
Identifier Type: -
Identifier Source: org_study_id
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