Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study

NCT06866301 | Active Not Recruiting

• 1 other identifier: SV-PA-21-AYUD/2021/58376
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anorexia Nervosa; microRNA; Gut Microbiota; Exercise; Physical Fitness; Mental Health; Body Composition

Outcome Measures

Primary Outcomes (5)

• Change of microRNA profile from baseline to week 12 and week 24

  microRNAs are epigenetic markers that are sensitive to lifestyle interventions. A possible change is an improved profile after exercise intervention. microRNAs are measured in reads per million

  Baseline, week 12 and week 24

• Change of gut microbiota profile from baseline to week 12 and week 24

  Gut microbiota is a group of bacteria that are sensitive to lifestyle interventions, stress and other environmental factors. A possible change is an improved profile after exercise intervention. Microbiota is measured in reads per million

  Baseline, week 12 and week 24

• Change of Eating Disorders Examination Questionnaire (EDE-Q) scores from baseline to week 12 and week 24

  The EDE-Q provides a global score and four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) derived from a 7-point Likert scale, where 0 indicates no symptoms or concerns and 6 indicates the most severe symptoms or concerns. Higher scores represent greater severity of eating disorder pathology

  Baseline, week 12 and week 24

• Change of muscle strength from baseline to week 12 and week 24

  Muscle strength is a physical fitness marker that is sensitive to lifestyle interventions. A possible change is an improved muscle strength after exercise intervention. Strength is measured in kilograms, Newtons, Watts, velocity (meters/second) or time (seconds).

  Baseline, week 12 and week 24

• Change of muscle content from baseline to week 12 and week 24

  Muscle content is a marker of health that is sensitive to lifestyle interventions and is measured with BioImpedance Analysis. A possible change is an improved muscle content after exercise intervention. Muscle content is measured in Kilograms or squared centimeters.

  Baseline, week 12 and week 24

Secondary Outcomes (7)

• Change of the anthropometric profile from baseline to week 12 and week 24

  Baseline, week 12 and week 24

• Change of fat content from baseline to week 12 and week 24

  Baseline, week 12 and week 24

• Change of functional capacity from baseline to week 12 and week 24

  Baseline, week 12 and week 24

• Change of Physical Activity Levels from baseline to week 12 and week 24

  Baseline, week 12 and week 24

• Change of Beck Depression Inventory 2 (BDI-2) from baseline to week 12 and week 24

  Baseline, week 12 and week 24

Other Outcomes (2)

• Change of Exercise Dependence Scale-Revised (EDS-R) scores from baseline to week 12 and week 24

  Baseline, week 12 and week 24

• Perceptions related to exercise resulted from the intervention after 24 weeks

  After 24 weeks

Study Arms (3)

AN-Intervention

EXPERIMENTAL

Patient enrolled in the exercise intervention group

Behavioral: Progressive Resistance Exercise

AN-Control

NO INTERVENTION

Patient enrolled in the non-exercise group

H-Control

NO INTERVENTION

Healthy controls in the non-exercise group

Interventions

Progressive Resistance Exercise BEHAVIORAL

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-Intervention

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A) Patients:
• 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.

You may not qualify if:

• A) Patients:
• 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.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33009, Spain

Location

MeSH Terms

Conditions

Anorexia Nervosa; Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Behavior; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: May 25, 2022
• Primary Completion: July 1, 2025
• Study Completion: November 30, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)