Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Maximal strength leg press
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AN according to the International Classification of Disorders version 10 (ICD-10)
- •BMI > 14.5
- •Signed informed consent form-
排除标准
- •Forced care
- •Unstable medical or psychiatric health
- •Issues with compliance to treatment
结局指标
主要结局
Maximal strength leg press
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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)