Anorexia NervosaSTRONG_2NCT04185727
Training Intervention in the Treatment of Anorexia Nervosa
A study testing Supervised strength training in people with Anorexia Nervosa and Exercise, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 2 sites in Denmark.
Trial summary
The scope of the STRONG_2 project is to investigate the effect of supervised exercise as add-on to standard of care (SOC), for patients with eating disorders (EDs). The effect of supervised strength training will be measured on health parameters such as muscle strength. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anorexia Nervosa, Exercise
- What is being tested?
- Supervised strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesDenmark
- Study dates
- 5 Dec 2019to 1 Jul 2020
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with AN according to the International Classification of Disorders version 10 (ICD-10)
- Age 18-35
- BMI > 14.5
- Signed informed consent form-
Who cannot join
- Forced care
- Unstable medical or psychiatric health
- Issues with compliance to treatment
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Eating disorder unit, Mental Health Center
Ballerup Municipality, Danmark, 2750
Institut for Idræt og Ernæring, NEXS, University of Copenhagen
Copenhagen, 2200 and 1958
About this study
Official title: Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)
The scope of the STRONG_2 project is to investigate the effect of supervised exercise as add-on to standard of care (SOC), for patients with eating disorders (EDs). The effect of supervised strength training will be measured on health parameters such as muscle strength. The study includes patients diagnosed with anorexia nervosa and in treatment at the Mental Health Center Ballerup (PCB) in the Capital Region of Denmark.
Read the detailed description
Eating disorders (EDs) are the most common psychiatric disorder affecting young women and contribute with serious psychological, social, physical health complications, and a high mortality rate.
The first general treatment goal of EDs is to address medical complications and suicide risk, and then pathological health effects of the EDs such as bingeing and vomiting. Thereafter, the aim is to address ED psychopathology and behaviors via different forms of psychotherapy. Medical treatment is also used to treat comorbidities.
Treatment of EDs using standard of care (SOC) often implies a reduction in physical activity, and exercise is often prohibited during the intense phase of weight restoration. Since many patients for lengthy periods of time use excessive exercise as a way of compensatory behavior for calorie intake, the sudden stop in physical activity may trigger anxiety and lack of compliance during the weight restoration program. In addition, many ED patients have osteopenia, reduced muscle mass and show signed of depressiveness, all of which benefits from physical activity.
In order to change unhealthy exercise in patients with eating disorders, it may be beneficial to experience exercise in a novel way as part of the treatment for EDs. The number of studies describing supervised exercise for patients with EDs are few, especially for studies examining the effects of implementing exercise in the treatment of EDs in a Danish context. The National Clinical Guidelines suggest that supervised physical activity should be considered in the weight gaining phase as a supplement for common treatment for patients with anorexia nervosa (AN), although there is no description of how this intervention should be implemented (Sundhedsstyrelsen 2005). Knowledge concerning patients' pathological use of training and how this could be managed during rehabilitation is inadequate.
The STRONG_2 project will compare the effects of supervised strength training as add on to standard of care (SOC) vs. SOC alone, in patients with EDs at the Mental Health Center Ballerup (PCB) in the Capital Region of Denmark. Training effects on health parameters including muscle strength, eating disorder psychopathology and pathological exercise will be explored.
The STRONG_2 study will enable an increased understanding of the effects of supervised strength training on muscle strength, increase in muscle mass, and improved bone health, metabolism as well as ED psychopathology.
- Conditions
- Anorexia Nervosa, Exercise
- Being tested
- Supervised strength training
- Keywords
- feeding and eating disorders, training, supervised exercise, muscle strength, anorexia nervosa, bone health, psychopathology, pathophysiology, intervention, prospective
- Medical subject headings
- Anorexia Nervosa, Motor Activity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised strength trainingOther
12 weeks supervised strength training exposure. The study will allocate patients to groups consisting of 4 members who receive strength training for 12 weeks. The strength training program will consist of three weekly supervised strength exercise sessions, each 40-60 min of duration, which starts with a 10 min warm-up and are completed with a meditation/relax session.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | Therapy control group |
| Standard of Care (SOC) + strength training | Experimental | Strength training intervention as add on to therapy Receives: Other: Supervised strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal strength leg press
Difference in muscle strength measured with leg press strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is leg press measured with 1 repetition maximum (1RM) in Kilograms (kg).
Measured: Base line, week 6, week 12
Maximal strength bench press
Difference in muscle strength measured with bench press strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is bench press measured with 1 repetition maximum (1RM) in Kilograms (kg).
Measured: Base line, week 6, week 12
Maximal strength pull down
Difference in muscle strength measured with pull down strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is pull down measured with 1 repetition maximum (1RM) in Kilograms (kg).
Measured: Base line, week 6, week 12
Secondary outcomes (27)
EDI-DT subscale score
Difference in drive for thinness measured with EDI questionnaire scores in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is on a scale from 1 to 6 where 6 means a better outcome.
Measured: Baseline, week 6, week 12, week 24
EDI subscale score
Difference in body dissatisfaction measured with EDI questionnaire scores in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is on a scale from 1 to 6 where 6 means a better outcome.
Measured: Baseline, week 6, week 12, week 24
Changes in Eating Disorder Symptoms
Difference in eating disorder symptoms measured with EDE-Q questionnaire in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is on a scale from 0 to 6 where 6 means a worse outcome.
Measured: Baseline, week 12, week 24
VAS-mood
Difference in mood measured with VAS-mood in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is on a Vas-scale from 0 to 10. For anxiety 10 means a worse outcome, for behavior 10 means a worse outcome and for feelings 10 means a worse outcome and for a happiness question 10 means the best outcome.
Measured: Baseline, week 1, week 6, week 12, week 24
Anxiety (HAM-A-6)
Difference in anxiety measured with HAM-A-6 questionnaire in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is on a scale from 0 to 4 and higher total score means a worse outcome.
Measured: Baseline, week 6, week 12, week 24
ERQ total score
Difference in emotional reactivity measured with ERQ questionnaire total score in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is on a scale from 1 to 7. With respect to questions for Cognitive Reappraisal Facets a higher score means better outcome and for questions regarding Expressive Suppression Facets a higher score means a worse outcome.
Measured: Baseline, week 6, week 12, week 24
RMR assessed by indirect calorimetry (ventilated open hood) and RMRratio
Difference in resting metabolic rate measured with indirect calorimetry and RMRratio in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Measured: Baseline, week 6, week 12
BMD assessed by Dual-energy X-ray Absorptiometry (DXA)
Difference in bone mineral density measured by Dual-energy X-ray Absorptiometry (DXA) (total bone mineral content, BMD lumbar spine and femur neck[g/m2]) in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Measured: Baseline, week 12
Anthropometry
Difference in anthropometry (bodyweight, fat mass, and fat free mass) measured with DXA in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Measured: Baseline, week 12
Blood samples Lipid profiles
Difference in biological parameters measured by changes in lipid levels, like cholesterol, high-density lipoprotein, low-density lipoprotein, very-low-density lipoproteins, triglycerides, free fatty acids, apolipoprotein a1 and B in blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training. Lipidomics, a mass spectrometry based systems level analysis of lipids will be applied for level analysis of lipids and their interacting partners. High or low risk lipid-profiles will be analysed in the two patient groups with high risk lipid profiles expected to mean a worse outcome.
Measured: Baseline,week 12
Blood samples Hormones
Difference in biological parameters measured by changes in hormone levels, like insulin, prostaglandins, cortisol, follicle stimulating hormone, ghrelin, obestatin, resistin, des- acyl-ghrelin, acyl-ghrelin, growth hormone, oxytocin, T3, cortisol, IGF-1, prolactin, estrogen, 17-beta-estradiol, LH, adiponectin, leptin, agouti-related protein, cholecystokinin, alpha-MSH, as well as related variants in blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training.
The project will examine whether higher levels or lower levels are correlated with a worse or better outcome in the two patient groups.
Measured: Baseline,week 12
Blood samples Neuronal biomarkers
Difference in biological parameters measured by changes in neuronal biomarker levels, like Glial cell line derived neurotrophic factor, Brain derived neurotrophic factor, Wnt- signaling pathway, nerve growth factor, insulin-like growth factor, S-110b, Neuron specific enolase, monoamines as well as related metabolites/variants, neuropeptide Y, HMGB1, as well as related isoforms in blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training.
The project will examine whether higher levels or lower levels are correlated with a worse or better outcome in the two patient groups.
Measured: Baseline,week 12
Weekly binge eating
Difference in weekly binge eating noted every week of the study in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is measured as number of binge eating during the week. A higher score means a worse outcome.
Measured: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
Vomiting
Difference in weekly vomiting noted every week of the study in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is measured as number of vomiting during the week. A higher score means a worse outcome.
Measured: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
Weekly use of laxatives
Difference in weekly use of laxatives noted every week of the study in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is measured as number of laxative use per week and the dose of the specific laxative used. A higher score and dose per week means a worse outcome.
Measured: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
EAI score
Difference in exercise addiction measured with (Exercise Addiction Inventory) EAI score in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is measured on a scale from 1 to 5 where higher score means a worse outcome.
Measured: Baseline, week 6, week 12, week 24
EDS score
Difference in exercise addiction measured with Exercise Dependence Scale (EDS) score in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is measured on a scale from 1 to 6 where higher score means a worse outcome.
Measured: Baseline, week 6, week 12, week 24
Body Awareness test (BAT)
Difference in body awareness measured with Body Awareness test (BAT) in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Questions are scored on a scale ranging from never to always with four items in between. Always means a worse outcome except for two questions regarding body satisfaction and relaxation where always means a better outcome.
Measured: Baseline, week 1,2,6,7,12 and week 24
Compulsive Exercise test
Difference in compulsive exercise measured with Compulsive Exercise test (CET) in patients treated with standard of care alone compared to patients treated with standard of care and strength training. 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: Baseline, week 1, 2, 6, 7, 12 and week 24
Activity and sleep tracking via Actigraph
Difference in activity/sleep measured with Actigraph in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Measured: Baseline, week 6, week 12, week 24
Readiness and motivations interview
Difference in readiness/motivations measured with Readiness and motivations interview in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is measured on a scale from 1 to 10 where higher score means a better outcome.
Measured: Baseline, week 1, week 6, week 7, week 12, week 24
Patient satisfaction: Expectations and experiences of ED-treatment scale
Difference in patient satisfaction measured with the Expectations and experiences of ED-treatment scale (Clinton 2001) in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is on a scale from 0 to 2 where higher score means worse outcome.
Measured: Baseline, week 6, week 12, week 24
Global Assessment of Functioning (GAF)
Difference in social functioning measured with numeric scale using the Global Assessment of Functioning (GAF-F and GAF-S) in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is measured on a scale from 1 to 99 where lower score means a worse outcome.
Measured: Baseline, week 6, week 12, week 24
Clinical Global Impression (CGI)
Difference in severity of the patient's illness measured with 7-point scale using the Clinical Global Impression - Severity scale (CGI-S) in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Scoring is on a scale from 1 to 7 where higher score means worse outcome.
Measured: Baseline, week 6, week 12, week 24
Bone turnover CTX-1
Difference in bone turnover measured with analyses of the bone marker CTX-1 from blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training. High levels above reference range which is 50 - 450 measured in pg/ml indicate worse outcome.
Measured: Baseline, week 12
Bone turnover PN1P
Difference in bone turnover measured with analyses of the bone formation marker PN1P from blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training. High levels above normal reference range which is 20 - 85 measured in microgram/L can indicate worse outcome.
Measured: Baseline, week 12
Bone turnover Osteocalcin
Difference in bone turnover measured with analyses of the bone marker Osteocalcin from blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training. Increased levels above normal reference range which is 0.7 - 6.5 measured in ng/ml mean higher osteoblast activity and formation of new bone and mean better outcome for most patients.
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start5 Dec 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: Corona.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled open trial, comparing the effect of Standard of care (SOC) with Standard of care + strength training. The interventional clinical trial design includes two parallel groups and 12 weeks exposure. The goal is to include 24-30 patients. The study will allocate patients to groups consisting of 4 members who receive either SOC or SOC + strength training for 12 weeks. All participants are assessed at baseline, after 1 week, after 6 weeks, post-treatment (12 weeks), and at 6 months' post follow-up (24 weeks) and monitored for changes in physiological, biological and psychological variables. Some tests are also done more frequently. The strength training program will consist of three weekly supervised strength exercise sessions, each 40-60 min of duration, which starts with a 10 min warm-up and are completed with a meditation/relax session.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of South-Eastern Norway
- Responsible party
- Sponsor
- Investigators
- Jan Magnus Sjögren, MD, PhD, Principal investigator, Eating disorder unit, Mental Health Services in the Capital Region, BallerupLouise B Rasmussen, MD, PhD, Study chair, Mental Health Services in the Capital Region, Ballerup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185727
- Sponsor's protocol ID
- H-19037864
- Acronym
- STRONG_2
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)
- ClinicalTrials.gov ID
- NCT04185727
- Acronym / sponsor ID
- STRONG_2 / H-19037864
- Conditions
- Anorexia Nervosa, Exercise
- Keywords
- feeding and eating disorders, training, supervised exercise, muscle strength, anorexia nervosa, bone health, psychopathology, pathophysiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corona.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of South-Eastern Norway
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 4 Dec 2019 (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.
The scope of the STRONG_2 project is to investigate the effect of supervised exercise as add-on to standard of care (SOC), for patients with eating disorders (EDs). The effect of supervised strength training will be measured on health parameters such as muscle strength. The study includes patients diagnosed with anorexia nervosa and in treatment at the Mental Health Center Ballerup (PCB) in the Capital Region of Denmark.
Detailed description
Eating disorders (EDs) are the most common psychiatric disorder affecting young women and contribute with serious psychological, social, physical health complications, and a high mortality rate.
The first general treatment goal of EDs is to address medical complications and suicide risk, and then pathological health effects of the EDs such as bingeing and vomiting. Thereafter, the aim is to address ED psychopathology and behaviors via different forms of psychotherapy. Medical treatment is also used to treat comorbidities.
Treatment of EDs using standard of care (SOC) often implies a reduction in physical activity, and exercise is often prohibited during the intense phase of weight restoration. Since many patients for lengthy periods of time use excessive exercise as a way of compensatory behavior for calorie intake, the sudden stop in physical activity may trigger anxiety and lack of compliance during the weight restoration program. In addition, many ED patients have osteopenia, reduced muscle mass and show signed of depressiveness, all of which benefits from physical activity.
In order to change unhealthy exercise in patients with eating disorders, it may be beneficial to experience exercise in a novel way as part of the treatment for EDs. The number of studies describing supervised exercise for patients with EDs are few, especially for studies examining the effects of implementing exercise in the treatment of EDs in a Danish context. The National Clinical Guidelines suggest that supervised physical activity should be considered in the weight gaining phase as a supplement for common treatment for patients with anorexia nervosa (AN), although there is no description of how this intervention should be implemented (Sundhedsstyrelsen 2005). Knowledge concerning patients' pathological use of training and how this could be managed during rehabilitation is inadequate.
The STRONG_2 project will compare the effects of supervised strength training as add on to standard of care (SOC) vs. SOC alone, in patients with EDs at the Mental Health Center Ballerup (PCB) in the Capital Region of Denmark. Training effects on health parameters including muscle strength, eating disorder psychopathology and pathological exercise will be explored.
The STRONG_2 study will enable an increased understanding of the effects of supervised strength training on muscle strength, increase in muscle mass, and improved bone health, metabolism as well as ED psychopathology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a randomized controlled open trial, comparing the effect of Standard of care (SOC) with Standard of care + strength training. The interventional clinical trial design includes two parallel groups and 12 weeks exposure. The goal is to include 24-30 patients. The study will allocate patients to groups consisting of 4 members who receive either SOC or SOC + strength training for 12 weeks. All participants are assessed at baseline, after 1 week, after 6 weeks, post-treatment (12 weeks), and at 6 months' post follow-up (24 weeks) and monitored for changes in physiological, biological and psychological variables. Some tests are also done more frequently. The strength training program will consist of three weekly supervised strength exercise sessions, each 40-60 min of duration, which starts with a 10 min warm-up and are completed with a meditation/relax session.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | No intervention | –Therapy control group |
| Standard of Care (SOC) + strength training | Experimental | Other: Supervised strength trainingStrength training intervention as add on to therapy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with AN according to the International Classification of Disorders version 10 (ICD-10)
- Age 18-35
- BMI > 14.5
- Signed informed consent form-
Key exclusion criteria (3 listed)
- Forced care
- Unstable medical or psychiatric health
- Issues with compliance to treatment
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 |
|---|---|---|
| Supervised strength training12 weeks supervised strength training exposure. The study will allocate patients to groups consisting of 4 members who receive strength training for 12 weeks. The strength training program will consist of three weekly supervised strength exercise sessions, each 40-60 min of duration, which starts with a 10 min warm-up and are completed with a meditation/relax session. | Other | Standard of Care (SOC) + strength training |
Primary outcome
Maximal strength leg press
Time frame: Base line, week 6, week 12
Difference in muscle strength measured with leg press strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is leg press measured with 1 repetition maximum (1RM) in Kilograms (kg).
Maximal strength bench press
Time frame: Base line, week 6, week 12
Difference in muscle strength measured with bench press strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is bench press measured with 1 repetition maximum (1RM) in Kilograms (kg).
Maximal strength pull down
Time frame: Base line, week 6, week 12
Difference in muscle strength measured with pull down strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is pull down measured with 1 repetition maximum (1RM) in Kilograms (kg).
27 secondary outcomes
EDI-DT subscale score
Time frame: Baseline, week 6, week 12, week 24
EDI subscale score
Time frame: Baseline, week 6, week 12, week 24
Changes in Eating Disorder Symptoms
Time frame: Baseline, week 12, week 24
VAS-mood
Time frame: Baseline, week 1, week 6, week 12, week 24
Anxiety (HAM-A-6)
Time frame: Baseline, week 6, week 12, week 24
ERQ total score
Time frame: Baseline, week 6, week 12, week 24
RMR assessed by indirect calorimetry (ventilated open hood) and RMRratio
Time frame: Baseline, week 6, week 12
BMD assessed by Dual-energy X-ray Absorptiometry (DXA)
Time frame: Baseline, week 12
Anthropometry
Time frame: Baseline, week 12
Blood samples Lipid profiles
Time frame: Baseline,week 12
Blood samples Hormones
Time frame: Baseline,week 12
Blood samples Neuronal biomarkers
Time frame: Baseline,week 12
Weekly binge eating
Time frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
Vomiting
Time frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
Weekly use of laxatives
Time frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
EAI score
Time frame: Baseline, week 6, week 12, week 24
EDS score
Time frame: Baseline, week 6, week 12, week 24
Body Awareness test (BAT)
Time frame: Baseline, week 1,2,6,7,12 and week 24
Compulsive Exercise test
Time frame: Baseline, week 1, 2, 6, 7, 12 and week 24
Activity and sleep tracking via Actigraph
Time frame: Baseline, week 6, week 12, week 24
Readiness and motivations interview
Time frame: Baseline, week 1, week 6, week 7, week 12, week 24
Patient satisfaction: Expectations and experiences of ED-treatment scale
Time frame: Baseline, week 6, week 12, week 24
Global Assessment of Functioning (GAF)
Time frame: Baseline, week 6, week 12, week 24
Clinical Global Impression (CGI)
Time frame: Baseline, week 6, week 12, week 24
Bone turnover CTX-1
Time frame: Baseline, week 12
Bone turnover PN1P
Time frame: Baseline, week 12
Bone turnover Osteocalcin
Time frame: Baseline, week 12
Results and safety
The study was stopped early (reason given: Corona.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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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.
Jan Magnus Sjögren, MD, PhD principal investigator
Eating disorder unit, Mental Health Services in the Capital Region, Ballerup
Louise B Rasmussen, MD, PhD study chair
Mental Health Services in the Capital Region, Ballerup
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised strength training in people with Anorexia Nervosa and Exercise, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 2 sites in Denmark.
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 4 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: stopped early, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 stopped early (reason given: Corona.). Results are not available in the source record.
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?
Maximal strength leg press (time frame: Base line, week 6, week 12). The study lists 3 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 26 Feb 2021.