Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)

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: NCT04185727
Recruitment Status : Terminated (Corona.)
First Posted : December 4, 2019
Last Update Posted : February 26, 2021
Sponsor:
Collaborators:
University of Copenhagen
University of South-Eastern Norway
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

Brief 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. The study includes patients diagnosed with anorexia nervosa and in treatment at the Mental Health Center Ballerup (PCB) in the Capital Region of Denmark.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Exercise Other: Supervised strength training Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)
Actual Study Start Date : December 5, 2019
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Arm Intervention/treatment
No Intervention: Standard of Care (SOC)
Therapy control group
Experimental: Standard of Care (SOC) + strength training
Strength training intervention as add on to therapy
Other: Supervised strength training
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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. EDI-DT subscale score [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  2. EDI subscale score [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  3. Changes in Eating Disorder Symptoms [ Time Frame: Baseline, week 12, week 24 ]
    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.

  4. VAS-mood [ Time Frame: Baseline, week 1, week 6, week 12, week 24 ]
    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.

  5. Anxiety (HAM-A-6) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  6. ERQ total score [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  7. RMR assessed by indirect calorimetry (ventilated open hood) and RMRratio [ Time Frame: Baseline, week 6, week 12 ]
    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.

  8. BMD assessed by Dual-energy X-ray Absorptiometry (DXA) [ Time Frame: Baseline, week 12 ]
    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.

  9. Anthropometry [ Time Frame: Baseline, week 12 ]
    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.

  10. Blood samples Lipid profiles [ Time Frame: Baseline,week 12 ]
    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.

  11. Blood samples Hormones [ Time Frame: Baseline,week 12 ]

    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.


  12. Blood samples Neuronal biomarkers [ Time Frame: Baseline,week 12 ]

    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.


  13. Weekly binge eating [ Time Frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24 ]
    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.

  14. Vomiting [ Time Frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24 ]
    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.

  15. Weekly use of laxatives [ Time Frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24 ]
    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.

  16. EAI score [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  17. EDS score [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  18. Body Awareness test (BAT) [ Time Frame: Baseline, week 1,2,6,7,12 and week 24 ]
    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.

  19. Compulsive Exercise test [ Time Frame: Baseline, week 1, 2, 6, 7, 12 and week 24 ]
    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.

  20. Activity and sleep tracking via Actigraph [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  21. Readiness and motivations interview [ Time Frame: Baseline, week 1, week 6, week 7, week 12, week 24 ]
    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.

  22. Patient satisfaction: Expectations and experiences of ED-treatment scale [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  23. Global Assessment of Functioning (GAF) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  24. Clinical Global Impression (CGI) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    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.

  25. Bone turnover CTX-1 [ Time Frame: Baseline, week 12 ]
    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.

  26. Bone turnover PN1P [ Time Frame: Baseline, week 12 ]
    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.

  27. Bone turnover Osteocalcin [ Time Frame: Baseline, week 12 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with AN according to the International Classification of Disorders version 10 (ICD-10)
  2. Age 18-35
  3. BMI > 14.5
  4. Signed informed consent form-

Exclusion Criteria:

  1. Forced care
  2. Unstable medical or psychiatric health
  3. Issues with compliance to treatment

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): NCT04185727


Locations
Layout table for location information
Denmark
Eating disorder unit, Mental Health Center
Ballerup, Danmark, Denmark, 2750
Institut for Idræt og Ernæring, NEXS, University of Copenhagen
Copenhagen, Denmark, 2200 and 1958
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
University of Copenhagen
University of South-Eastern Norway
Investigators
Layout table for investigator information
Principal Investigator: Jan Magnus Sjögren, MD, PhD Eating disorder unit, Mental Health Services in the Capital Region, Ballerup
Study Chair: Louise B Rasmussen, MD, PhD Mental Health Services in the Capital Region, Ballerup
Layout table for additonal information
Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT04185727    
Other Study ID Numbers: H-19037864
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mental Health Services in the Capital Region, Denmark:
feeding and eating disorders
training
supervised exercise
muscle strength
anorexia nervosa
bone health
psychopathology
pathophysiology
intervention
prospective
Additional relevant MeSH terms:
Layout table for MeSH terms
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders