Clinical trial NCT04185727: Training Intervention in the Treatment of Anorexia Nervosa
Official title: Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anorexia Nervosa
Exercise
Keywords: feeding and eating disorders
training
supervised exercise
muscle strength
anorexia nervosa
bone health
psychopathology
pathophysiology
intervention
prospective
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: University of South-Eastern Norway
First posted: 2019-12-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Maximal strength leg press
timeFrame: Base line, week 6, week 12
measure: Maximal strength bench press
timeFrame: Base line, week 6, week 12
measure: Maximal strength pull down
timeFrame: Base line, week 6, week 12
Secondary outcomes:
measure: EDI-DT subscale score
timeFrame: Baseline, week 6, week 12, week 24
measure: EDI subscale score
timeFrame: Baseline, week 6, week 12, week 24
measure: Changes in Eating Disorder Symptoms
timeFrame: Baseline, week 12, week 24
measure: VAS-mood
timeFrame: Baseline, week 1, week 6, week 12, week 24
measure: Anxiety (HAM-A-6)
timeFrame: Baseline, week 6, week 12, week 24
measure: ERQ total score
timeFrame: Baseline, week 6, week 12, week 24
measure: RMR assessed by indirect calorimetry (ventilated open hood) and RMRratio
timeFrame: Baseline, week 6, week 12
measure: BMD assessed by Dual-energy X-ray Absorptiometry (DXA)
timeFrame: Baseline, week 12
measure: Anthropometry
timeFrame: Baseline, week 12
measure: Blood samples Lipid profiles
timeFrame: Baseline,week 12
measure: Blood samples Hormones
timeFrame: Baseline,week 12
measure: Blood samples Neuronal biomarkers
timeFrame: Baseline,week 12
measure: Weekly binge eating
timeFrame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
measure: Vomiting
timeFrame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
measure: Weekly use of laxatives
timeFrame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
measure: EAI score
timeFrame: Baseline, week 6, week 12, week 24
measure: EDS score
timeFrame: Baseline, week 6, week 12, week 24
measure: Body Awareness test (BAT)
timeFrame: Baseline, week 1,2,6,7,12 and week 24
measure: Compulsive Exercise test
timeFrame: Baseline, week 1, 2, 6, 7, 12 and week 24
measure: Activity and sleep tracking via Actigraph
timeFrame: Baseline, week 6, week 12, week 24
measure: Readiness and motivations interview
timeFrame: Baseline, week 1, week 6, week 7, week 12, week 24
measure: Patient satisfaction: Expectations and experiences of ED-treatment scale
timeFrame: Baseline, week 6, week 12, week 24
measure: Global Assessment of Functioning (GAF)
timeFrame: Baseline, week 6, week 12, week 24
measure: Clinical Global Impression (CGI)
timeFrame: Baseline, week 6, week 12, week 24
measure: Bone turnover CTX-1
timeFrame: Baseline, week 12
measure: Bone turnover PN1P
timeFrame: Baseline, week 12
measure: Bone turnover Osteocalcin
timeFrame: Baseline, week 12
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Eating disorder unit, Mental Health Center
state: Danmark
city: Copenhagen
country: Denmark
facility: Institut for Idræt og Ernæring, NEXS, University of Copenhagen
Study officials:
affiliation: Eating disorder unit, Mental Health Services in the Capital Region, Ballerup
name: Jan Magnus Sjögren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mental Health Services in the Capital Region, Ballerup
name: Louise B Rasmussen, MD, PhD
role: STUDY_CHAIR
References: