Clinical trial NCT05039385: Exercise Program in Patients With Anorexia Nervosa (ESATRAL)
Official title: Impact of a Supervised Physical Exercise Program (ESATRAL) in Patients With Anorexia Nervosa After Hospital Discharge
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anorexia
Keywords: Exercise
Resistance training
Anorexia
Physical activity
Anorexia nervosa
Eating disorders
Exercise treatment
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
Collaborators: name: PERFORMA Salud S.L.
name: ITA PREVI Valencia
First posted: 2021-09-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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).

Detailed description: Experts in eating disorders recommend restricting exercise until the person is medically stable, of sufficient weight and able to compensate exercise with sufficient energy intake. In this sense, a reintroduction and promotion of healthy exercise should be done in a graded and supervised manner, where exercise would provide great benefits, such as improving social confidence and providing a tool for healthy living. That is the goal of the ESATRAL (EXCERCISE AND HEALTH IN EATING DISSORDERS) program. The relationship between eating disorders (ED) and exercise has been controversial, but different studies have already shown that the therapeutic use of exercise in the treatment could be positive if used as a tool for healthy living. Historically in the literature, exercise in anorexia has been mainly considered as a problematic activity that should be limited or even completely forbidden, especially during the acute phase of the disorder, but different researchers have already questioned the restriction-based approach to exercise and investigated its potentially healthy role in recovery. It should also be noted that restricting physical activity can have detrimental musculoskeletal and cardiometabolic consequences for patients with anorexia. In addition to experiencing significant strength losses and atrophy of type II muscle fibers, the loss of lean tissue affects organ mass and function in these patients. Lean body mass-comprised of visceral organs such as the liver and heart, as well as bone and skeletal muscle-plays an important role in setting the demand for energy metabolism. Patients with anorexia present with a number of characteristic metabolic and endocrine disorders as a result of chronic malnutrition that affect lean tissue. ESATRAL is a supervised physical exercise program that is implemented in patients with anorexia nervosa after hospital discharge. ESATRAL consists of three days of weekly strength training that will be measured following the strength-velocity methodology. 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 (6 month duration) in patients with anorexia nervosa after hospital discharge. The risk of relapse is an obstacle that can be minimized if supervised exercise were included in the treatment of anorexia as is done in ESATRAL. Many patients engage in excessive and unsupervised exercise, and returning to this level of physical activity after treatment has been associated with an increased risk of relapse. Therefore, prohibiting exercise during treatment may increase the likelihood that patients will fall back into old patterns after treatment ends, hence the importance of ESATRAL.

The ESATRAL project will compare the effects of supervised strength training as a part of the treatment vs. treatment without supervised strength training, in patients with Anorexia nervosa after hospital discharge. All participants will be assessed at baseline, after 12 weeks, post-treatment (24 weeks), and at 9 months' post follow-up (36 weeks). .

The study will be conducted with ITA- PREVI patients at the PERFORMA personal training health center in Valencia.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Risk of eating disorders
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in Maximal strength horizontal pull based on the execution velocity.
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in Maximal strength bench press based on the execution velocity.
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in Maximal strength squat based on the execution velocity.
timeFrame: Base line, week 12, week 24, week 36
Secondary outcomes:
measure: Changes in Blood pressure
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in Bone Mineral Density
timeFrame: Base line, week 24, week 36
measure: Changes in Heart Rate
timeFrame: Base line, week 12, week 24, week 36
measure: Restoration of ovarian function
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in Height
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in bodyweight
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in corporal composition
timeFrame: Base line, week 12, week 24, week 36
measure: Demographic variables
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in perceived quality of life
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in eating attitudes
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in compulsive exercise
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in body image
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in agility
timeFrame: Base line, week 12, week 24, week 36
measure: Structured physical activity
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in physical performance of the lower extremities
timeFrame: Base line, week 12, week 24, week 36
measure: Changes in functionality
timeFrame: Base line, week 12, week 24, week 36
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ita Previ Valencia
Study officials:
affiliation: Catholic University of Valencia
name: Ana Pablos Monzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: