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Exercise Program in Patients With Anorexia Nervosa (ESATRAL) (ESATRAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05039385
Recruitment Status : Withdrawn (not enough sample was obtained)
First Posted : September 9, 2021
Last Update Posted : May 11, 2022
Sponsor:
Collaborators:
PERFORMA Salud S.L.
ITA PREVI Valencia
Information provided by (Responsible Party):
Ana Pablos Monzó, Fundación Universidad Católica de Valencia San Vicente Mártir

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).


Condition or disease Intervention/treatment Phase
Anorexia Other: Exercise Program focused on resistance training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).

Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Impact of a Supervised Physical Exercise Program (ESATRAL) in Patients With Anorexia Nervosa After Hospital Discharge
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2023

Arm Intervention/treatment
Experimental: ESATRAL Group
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

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.


No Intervention: Control Group
They will follow their daily treatment without added exercise



Primary Outcome Measures :
  1. Changes in Risk of eating disorders [ Time Frame: Base line, week 12, week 24, week 36 ]
    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.

  2. Changes in Maximal strength horizontal pull based on the execution velocity. [ Time Frame: Base line, week 12, week 24, week 36 ]
    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.

  3. Changes in Maximal strength bench press based on the execution velocity. [ Time Frame: Base line, week 12, week 24, week 36 ]
    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.

  4. Changes in Maximal strength squat based on the execution velocity. [ Time Frame: Base line, week 12, week 24, week 36 ]
    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.


Secondary Outcome Measures :
  1. Changes in Blood pressure [ Time Frame: Base line, week 12, week 24, week 36 ]
    Changes related to blood pressure (systolic and diastolic pressure) will be measured in patients treated with standard treatment compared to patients treated with ESATRAL with an Omron Digital Automatic Blood Pressure Monitor Hem Arm 7114 with pediatric cuff (mmHg).

  2. Changes in Bone Mineral Density [ Time Frame: Base line, week 24, week 36 ]
    Difference in bone mineral density (BMD) measured by Dual-energy X-ray Absorptiometry (DXA) (total bone mineral content, BMD lumbar spine and femur neck) in patients treated with standard treatment compared to patients treated with ESATRAL. It will be measured in g/m2].

  3. Changes in Heart Rate [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in heart rate measured with Polar RS800CX heart rate monitor in patients treated with standard treatment compared to patients treated with ESATRAL (beats per minute).

  4. Restoration of ovarian function [ Time Frame: Base line, week 12, week 24, week 36 ]
    Changes in ovarian function from interviews conducted by the endocrine physician in patients treated with standard treatment compared to patients treated with ESATRAL (answer: yes, no).

  5. Changes in Height [ Time Frame: Base line, week 12, week 24, week 36 ]
    It will be measured by attaching a Seca scale to the Seca 714 scale (Seca Vogel & Halke GmbH & Co. KG, Hamburg, Germany), with an accuracy of 0.1 cm.

  6. Changes in bodyweight [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in bodyweight (kg) with Tanita MC-780MA in patients treated with standard treatment compared to patients treated with ESATRAL.

  7. Changes in corporal composition [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in fat mass (kg), and fat free mass (kg) measured with DXA and Tanita MC-780MA in patients treated with standard treatment compared to patients treated with ESATRAL.

  8. Demographic variables [ Time Frame: Base line, week 12, week 24, week 36 ]

    The following demographic variables will be taken to characterize the sample:

    Age, type of anorexia (diagnosed in the Hospital), time of evolution of the disease and BMI (BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared).


  9. Changes in perceived quality of life [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in quality of life measured with SF-12v2 (Ware et al., 2009) in patients treated with standard treatment compared to patients treated with ESATRAL. Scoring is on a scale from 0 to 100 where higher score means a better perceived state of health.

  10. Changes in eating attitudes [ Time Frame: Base line, week 12, week 24, week 36 ]

    Difference in attitudes towards food measured with EAT-26 (Garner et al., 1982) in patients treated with standard treatment compared to patients treated with ESATRAL.

    Scoring is on a scale from 0 to 78. Higher scores indicate greater risk of an eating disorder and total scores 20 or above are considered to be in the clinical range.


  11. Changes in compulsive exercise [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in compulsive exercise measured with Compulsive Exercise test (CET) in patients treated with standard treatment compared to patients treated with ESATRAL. Scoring is measured on a scale from 0 to 5 where higher score means a worse outcome except for two questions where higher score means better outcome.

  12. Changes in body image [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in body image measured through the Multidimensional Body Self Relations Questionnaire (MBSRQ) (Cash, 2000) in patients treated with standard treatment compared to patients treated with ESATRAL. Scoring is measured on a scale from 0 to 5 where the higher the score, the greater the satisfaction with one's own body image.

  13. Changes in agility [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in agility measured with the 3 and 10 m Time Up and Go (TUG) test (San Juan et al. 2008) and the Timed Up and Down Stairs (TUDS) test (Gocha et al. 2001) in patients treated with standard treatment compared to patients treated with ESATRAL. In both tests the time necessary to perform the test is taken and the longer the time the worse the agility.

  14. Structured physical activity [ Time Frame: Base line, week 12, week 24, week 36 ]
    Daily time spent in structured ligth, moderate or vigorous intensity (percentage) physical activity will be measured using the ActiGraph GT9X Link to compare patients treated with standard treatment with patients treated with ESATRAL.

  15. Changes in physical performance of the lower extremities [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in the physical performance of the lower extremities measured with the Short Physical Performance Battery in patients treated with standard treatment compared to patients treated with ESATRAL.

  16. Changes in functionality [ Time Frame: Base line, week 12, week 24, week 36 ]
    Difference in the function of the participants with respect to day-to-day activities measured with the Barthel Index (Mahoney and Barthel, 1965) in patients treated with standard treatment compared to patients treated with ESATRAL. The range of scores obtained goes from 0 to100 points. A total score of 100 indicates complete self-sufficiency in performance, while a score of zero would indicate absolute dependence. A score obtained between 21 and 60 is indicative of a severe dependency, while scores higher than this limit of 60 points would describe almost all the people who are independent for the execution of these activities.



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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05039385


Locations
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Spain
Ita Previ Valencia
Valencia, Spain, 46023
Sponsors and Collaborators
Fundación Universidad Católica de Valencia San Vicente Mártir
PERFORMA Salud S.L.
ITA PREVI Valencia
Investigators
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Principal Investigator: Ana Pablos Monzo, PhD Catholic University of Valencia
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Responsible Party: Ana Pablos Monzó, Principal investigator, Fundación Universidad Católica de Valencia San Vicente Mártir
ClinicalTrials.gov Identifier: NCT05039385    
Other Study ID Numbers: UCV/2019-2020/143
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Pablos Monzó, Fundación Universidad Católica de Valencia San Vicente Mártir:
Exercise
Resistance training
Anorexia
Physical activity
Anorexia nervosa
Eating disorders
Exercise treatment
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders