Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change of microRNA profile from baseline to week 12 and week 24 — Baseline, 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
• Change of gut microbiota profile from baseline to week 12 and week 24 — Baseline, 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
• Change of Eating Disorders Examination Questionnaire (EDE-Q) scores from baseline to week 12 and week 24 — Baseline, 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
• Change of muscle strength from baseline to week 12 and week 24 — Baseline, 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).
• Change of muscle content from baseline to week 12 and week 24 — Baseline, 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.

Trial sites (1)

More University of Oviedo trials in Spain

Other trials for the same condition