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Clinical Trials/NCT04185727
NCT04185727
Terminated
Not Applicable

Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)

Mental Health Services in the Capital Region, Denmark2 sites in 1 country5 target enrollmentDecember 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
Mental Health Services in the Capital Region, Denmark
Enrollment
5
Locations
2
Primary Endpoint
Maximal strength leg press
Status
Terminated
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 5, 2019
End Date
July 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mental Health Services in the Capital Region, Denmark
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with AN according to the International Classification of Disorders version 10 (ICD-10)
  • BMI \> 14.5
  • Signed informed consent form-

Exclusion Criteria

  • Forced care
  • Unstable medical or psychiatric health
  • Issues with compliance to treatment

Outcomes

Primary Outcomes

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 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).

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).

Secondary Outcomes

  • Changes in Eating Disorder Symptoms(Baseline, week 12, week 24)
  • EDI subscale score(Baseline, week 6, week 12, week 24)
  • Anthropometry(Baseline, week 12)
  • Blood samples Lipid profiles(Baseline,week 12)
  • Weekly use of laxatives(Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24)
  • Body Awareness test (BAT)(Baseline, week 1,2,6,7,12 and week 24)
  • EDI-DT subscale score(Baseline, week 6, week 12, week 24)
  • Anxiety (HAM-A-6)(Baseline, week 6, week 12, week 24)
  • ERQ total score(Baseline, week 6, week 12, week 24)
  • Vomiting(Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24)
  • Compulsive Exercise test(Baseline, week 1, 2, 6, 7, 12 and week 24)
  • Activity and sleep tracking via Actigraph(Baseline, week 6, week 12, week 24)
  • VAS-mood(Baseline, week 1, week 6, week 12, week 24)
  • Weekly binge eating(Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24)
  • RMR assessed by indirect calorimetry (ventilated open hood) and RMRratio(Baseline, week 6, week 12)
  • BMD assessed by Dual-energy X-ray Absorptiometry (DXA)(Baseline, week 12)
  • Blood samples Hormones(Baseline,week 12)
  • Blood samples Neuronal biomarkers(Baseline,week 12)
  • EAI score(Baseline, week 6, week 12, week 24)
  • EDS score(Baseline, week 6, week 12, week 24)
  • Patient satisfaction: Expectations and experiences of ED-treatment scale(Baseline, week 6, week 12, week 24)
  • Global Assessment of Functioning (GAF)(Baseline, week 6, week 12, week 24)
  • Clinical Global Impression (CGI)(Baseline, week 6, week 12, week 24)
  • Bone turnover PN1P(Baseline, week 12)
  • Readiness and motivations interview(Baseline, week 1, week 6, week 7, week 12, week 24)
  • Bone turnover Osteocalcin(Baseline, week 12)
  • Bone turnover CTX-1(Baseline, week 12)

Study Sites (2)

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