Exercise Program in Patients With Anorexia Nervosa (ESATRAL)

Anorexia Clinical Trial

— ESATRAL  

Official title:

Impact of a Supervised Physical Exercise Program (ESATRAL) in Patients With Anorexia Nervosa After Hospital Discharge

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05039385
• Other study ID #: UCV/2019-2020/143
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2022
• Source: Fundación Universidad Católica de Valencia San Vicente Mártir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.

Locations

Country	Name	City	State
Spain	Ita Previ Valencia	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Universidad Católica de Valencia San Vicente Mártir	ITA PREVI Valencia, PERFORMA Salud S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Changes in Blood pressure	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).	Base line, week 12, week 24, week 36
Secondary	Changes in Bone Mineral Density	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].	Base line, week 24, week 36
Secondary	Changes in Heart Rate	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).	Base line, week 12, week 24, week 36
Secondary	Restoration of ovarian function	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).	Base line, week 12, week 24, week 36
Secondary	Changes in Height	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.	Base line, week 12, week 24, week 36
Secondary	Changes in bodyweight	Difference in bodyweight (kg) with Tanita MC-780MA in patients treated with standard treatment compared to patients treated with ESATRAL.	Base line, week 12, week 24, week 36
Secondary	Changes in corporal composition	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.	Base line, week 12, week 24, week 36
Secondary	Demographic variables	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).	Base line, week 12, week 24, week 36
Secondary	Changes in perceived quality of life	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.	Base line, week 12, week 24, week 36
Secondary	Changes in eating attitudes	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.	Base line, week 12, week 24, week 36
Secondary	Changes in compulsive exercise	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.	Base line, week 12, week 24, week 36
Secondary	Changes in body image	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.	Base line, week 12, week 24, week 36
Secondary	Changes in agility	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.	Base line, week 12, week 24, week 36
Secondary	Structured physical activity	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.	Base line, week 12, week 24, week 36
Secondary	Changes in physical performance of the lower extremities	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.	Base line, week 12, week 24, week 36
Secondary	Changes in functionality	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.	Base line, week 12, week 24, week 36