AnorexiaESATRALNCT05039385
Exercise Program in Patients With Anorexia Nervosa (ESATRAL)
A study testing Exercise Program focused on resistance training in people with Anorexia, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Anorexia
- What is being tested?
- Exercise Program focused on resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Supervised Physical Exercise Program (ESATRAL) in Patients With Anorexia Nervosa After Hospital Discharge
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).
Read the 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.
- Conditions
- Anorexia
- Being tested
- Exercise Program focused on resistance training
- Keywords
- Exercise, Resistance training, Anorexia, Physical activity, Anorexia nervosa, Eating disorders, Exercise treatment
- Medical subject headings
- Anorexia, Motor Activity, Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Program focused on resistance trainingOther
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:
- 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%).
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Program focused on resistance training |
| Control Group | No intervention | They will follow their daily treatment without added exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Base line, week 12, week 24, week 36
Secondary outcomes (16)
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).
Measured: Base line, week 12, week 24, week 36
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].
Measured: Base line, week 24, week 36
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).
Measured: Base line, week 12, week 24, week 36
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).
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
Changes in bodyweight
Difference in bodyweight (kg) with Tanita MC-780MA in patients treated with standard treatment compared to patients treated with ESATRAL.
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
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).
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
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.
Measured: Base line, week 12, week 24, week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Sep 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2023 (estimated)
Why it stopped: not enough sample was obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Collaborators
- PERFORMA Salud S.L., ITA PREVI Valencia
- Responsible party
- Principal investigator, Ana Pablos Monzó, Fundación Universidad Católica de Valencia San Vicente Mártir
- Investigators
- Ana Pablos Monzo, PhD, Principal investigator, Catholic University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039385
- Sponsor's protocol ID
- UCV/2019-2020/143
- Acronym
- ESATRAL
- Status last verified
- May 2022
- First submitted
- 22 Jul 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Supervised Physical Exercise Program (ESATRAL) in Patients With Anorexia Nervosa After Hospital Discharge
- ClinicalTrials.gov ID
- NCT05039385
- Acronym / sponsor ID
- ESATRAL / UCV/2019-2020/143
- Conditions
- Anorexia
- Keywords
- Exercise, Resistance training, Anorexia, Physical activity, Anorexia nervosa, Eating disorders, Exercise treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not enough sample was obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Collaborators
- PERFORMA Salud S.L., ITA PREVI Valencia
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| ESATRAL Group | Experimental | Other: Exercise Program focused on resistance trainingThey 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. |
| Control Group | No intervention | –They will follow their daily treatment without added exercise |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Program focused on resistance trainingThe 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. | Other | ESATRAL Group |
Primary outcome
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.
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.
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.
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.
16 secondary outcomes
Changes in Blood pressure
Time frame: Base line, week 12, week 24, week 36
Changes in Bone Mineral Density
Time frame: Base line, week 24, week 36
Changes in Heart Rate
Time frame: Base line, week 12, week 24, week 36
Restoration of ovarian function
Time frame: Base line, week 12, week 24, week 36
Changes in Height
Time frame: Base line, week 12, week 24, week 36
Changes in bodyweight
Time frame: Base line, week 12, week 24, week 36
Changes in corporal composition
Time frame: Base line, week 12, week 24, week 36
Demographic variables
Time frame: Base line, week 12, week 24, week 36
Changes in perceived quality of life
Time frame: Base line, week 12, week 24, week 36
Changes in eating attitudes
Time frame: Base line, week 12, week 24, week 36
Changes in compulsive exercise
Time frame: Base line, week 12, week 24, week 36
Changes in body image
Time frame: Base line, week 12, week 24, week 36
Changes in agility
Time frame: Base line, week 12, week 24, week 36
Structured physical activity
Time frame: Base line, week 12, week 24, week 36
Changes in physical performance of the lower extremities
Time frame: Base line, week 12, week 24, week 36
Changes in functionality
Time frame: Base line, week 12, week 24, week 36
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No. No data will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Pablos Monzo, PhD principal investigator
Catholic University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program focused on resistance training in people with Anorexia, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Risk of eating disorders (time frame: Base line, week 12, week 24, week 36). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.