Exercise Program in Patients With Anorexia Nervosa (ESATRAL)

NCT05039385 | Withdrawn

• 1 other identifier: UCV/2019-2020/143
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Excessive physical exercise is one of the main symptoms of anorexia and a common restrictive behavior used by patients, which is associated with less short- and long-term treatment success. Supervised exercise has shown these benefits in patients with anorexia: opportunity to learn and acquire knowledge and information on how to perform physical activity in a healthy, safe and moderate way, less feelings of incapacity; lower risk of relapse; prohibiting exercise during treatment can increase the likelihood that patients will revert to old patterns once therapy is completed. Exercise can be as effective as antidepressants and psychological therapies to treat some cases of depression present in anorexia. The objective of the ESATRAL program is to analyze the physiological, psychological, body composition, physical condition and functionality effects of a supervised strength-focused training program in patients with anorexia nervosa after hospital discharge. All participants are assessed at baseline, after 12 weeks, post-treatment (24 weeks), and at 9 months' post follow-up (36 weeks).

Conditions

Anorexia

Keywords

Exercise; Resistance training; Anorexia; Physical activity; Anorexia nervosa; Eating disorders; Exercise treatment

Outcome Measures

Primary Outcomes (4)

• Changes in Risk of eating disorders

  The Eating Disorder Inventory-3 will be used. It made up of 91 items organized into 12 subscales (3 specific to eating disorders and 9 general psychological scales). It uses a 0-4 point scoring system. Higher scores indicating greater risk of an eating disorder.

  Base line, week 12, week 24, week 36

• Changes in Maximal strength horizontal pull based on the execution velocity.

  Difference in muscle strength measured with horizontal pull strength tests in patients treated with standard treatment compared to patients treated with ESATRAL. To measure muscle strength we will use a linear encoder (T-FORCE dynamic measurement system) to achieve the movement speed. The exercise will be done in a Smith Machine.

  Base line, week 12, week 24, week 36

• Changes in Maximal strength bench press based on the execution velocity.

  Difference in muscle strength measured with horizontal bench press tests in patients treated with standard treatment compared to patients treated with ESATRAL. To measure muscle strength we will use a linear encoder (T-FORCE dynamic measurement system) to achieve the movement speed. The exercise will be done in a Smith Machine.

  Base line, week 12, week 24, week 36

• Changes in Maximal strength squat based on the execution velocity.

  Difference in muscle strength measured with squat tests in patients treated with standard treatment compared to patients treated with ESATRAL. To measure muscle strength we will use a linear encoder (T-FORCE dynamic measurement system) to achieve the movement speed. The exercise will be done in a Smith Machine.

  Base line, week 12, week 24, week 36

Secondary Outcomes (16)

• Changes in Blood pressure

  Base line, week 12, week 24, week 36

• Changes in Bone Mineral Density

  Base line, week 24, week 36

• Changes in Heart Rate

  Base line, week 12, week 24, week 36

• Restoration of ovarian function

  Base line, week 12, week 24, week 36

• Changes in Height

  Base line, week 12, week 24, week 36

Study Arms (2)

ESATRAL Group

EXPERIMENTAL

They will perform the supervised physical exercise program. The supervised exercise program (ESATRAL) will last 24 weeks with 2-3 non-consecutive weekly sessions. The duration of each session will be 30 minutes and will progressively increase depending on the phase in which we are until reaching 60 minutes.

Other: Exercise Program focused on resistance training

Control Group

NO INTERVENTION

They will follow their daily treatment without added exercise

Interventions

Exercise Program focused on resistance training OTHER

The program will be carried out by a personal trainer. To ensure correct execution, given that the groups will be of a maximum of 5 people. Each session will include: A) Warm up: movility exercises and coordination games B) Main part: 3 exercises will be included to strengthen different muscle groups (pull , bench press and back squat). Velocity based training (VBT) will be used to control load. 3 sets of 16-30 repetitions mantaining the speed between Light (estimated loss of speed of the series 5-10%). C) Cool down: feedback with patients based on the work of Stiles-Shields (2015). Specific training content will focus on safety, while re-educating patients on proper exercise methods, motivation-related attitudes, and transparency on health benefits and potential harms as a result of increased exercise.

ESATRAL Group

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women with a BMI higher than 15 Kg / m2,
• aged between 16 to 45 years old,
• diagnosed with restrictive (DSM-V F50.01) or purgative (F50.02 (DSM-V) anorexia.
• Patients from the 24 h or Day Hospital and ambulatory.
• who has agreed to participate in the study and signed the informed consent or in case of being minors, their father / mother / legal guardian signs the participation consent.

You may not qualify if:

• Patients with contraindication in the performance of physical exercise (cardiovascular risk factors),
• patients with severe mental disorder (major depressive episode, bipolar disorder, severe personality disorders, schizophrenia)
• Patients who refuse to sign the informed consent.

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead
• PERFORMA Salud S.L.: collaborator
• ITA PREVI Valencia: collaborator

Study Sites (1)

Ita Previ Valencia

Valencia, 46023, Spain

Location

MeSH Terms

Conditions

Anorexia; Motor Activity; Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Mental Disorders

Study Officials

• Ana Pablos Monzo, PhD

  Catholic University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator: The persons who make the data analysis and decide whether a patient has experienced an outcome of interest will be masked. Outcome assessors: The persons who assess patients and provide outcome data will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. Thus, the subjects participating in the study will be divided into 2 groups, one of which will perform the exercise program (intervention group, IG), and another that will follow their daily routine treatment without added exercise (control group, CG). Each group will have 4 measurements in which the corresponding variables will be evaluated: A) before the start of the intervention, B) at 3 months (12 weeks), C) at 6 months (at the end of the intervention, 24 weeks), D) at 9 months (3 months post-intervention, 36 weeks).

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: September 9, 2021
• Study Start: September 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)