Aerobic Exercise as add-on Treatment for Inpatients With Depression: Effects and Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Depressive Symptoms self rated
研究概览
简要总结
The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as adon treatment for moderately to severely depressed inpatients. Endpoints are symptom severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV).
Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post (+6weeks) in already existing blood samples.
详细描述
Patients are randomly assigned to the intervention group (IG) or control group (CG). The IG will train three times per week on indoor bicycles at 60 to 75% of maximal heartrate aiming at a weekly total of 17.5kcal/kg bodyweight for 6 consecutive weeks. The exercise will take place under supervision. CG will absolve a basic stretching and mobilisation program 3 times per week, also under supervision for 6 consecutive weeks. At the end of every week physical fitness is evaluated by the queens step test. No other activities with moderate or high intensity are allowed throughout the intervention time.
All patients will participate in the multimodal treatment program of the depression ward, which includes pharmacotherapy, psychotherapy and specialized therapies such as art therapy and ergotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient treatment on the Depression ward
- •International Classification of Diseases (ICD)-10: F32, F33 or F31
- •HDRS-17>16 Points
- •written informed consent
排除标准
- •Any physical condition that prohibits endurance exercise
- •3 or more cardiovascular risk factors (hypertonia, family history, smoking, hypertriglyceridemia, diabetes)
- •pathological ECG
- •BMI > 35 kg/m2
- •Pregnancy
- •acute suicidal Ideation
- •comorbid substance dependence (except nicotine)
- •Major comorbid psychiatric disorder
- •regular high intensity exercise prior to treatment
研究组 & 干预措施
Exercise (IG)
Aerobic exercise three times per week on indoor bicycles at 60 to 75% of maximal heartrate aiming at a weekly total of 17.5kcal/kg bodyweight for 6 consecutive weeks. The exercise will take place under supervision. At the end of every week physical fitness is evaluated by the queens step test.No other activities with moderate or high intensity are allowed throughout the intervention time.
干预措施: Aerobic exercise (Behavioral)
Control (CG)
Basic stretching and mobilisation program 3 times per week each for approx. 40 minutes, also under supervision for 6 consecutive weeks. At the end of every week physical fitness is evaluated by the queens step test.At the end of every week physical fitness is evaluated by the queens step test.No other activities with moderate or high intensity are allowed throughout the intervention time.
干预措施: Placebo control (Behavioral)
结局指标
主要结局
Depressive Symptoms self rated
时间窗: Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (followup)
Change in Score of Hamilton Depression Rating Scale (HDRS-17) from baseline until 6 months follow-up
Depressive Symptoms physician rated
时间窗: Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (follow-up)
Change in Score of Beck Depression Inventory (BDI) from baseline until 6 months follow-up
次要结局
- Psychological symptoms(Baseline (pre), 6 weeks (post), 6 months (follow-up))
- Sleep (Polysomnography)(Baseline (pre), 6 weeks (post))
- Social stress - cortisol(Baseline (pre), 6 weeks (post))
- Mental Toughness(Baseline (pre), 6 weeks (post), 6 months (followup))
- Cognition(Baseline (pre), 6 weeks (post), 6 months (followup))
- Physical activity(Baseline (pre), 6 months (follow-up))
- TNF-Alpha (additional value assessed/Amendment 1)(Baseline (pre), 2 weeks (post), 6 weeks (post))
- Cortisol awakening response (CAR)(Baseline (pre), 2 weeks, 6 weeks (post), 6 months (follow-up))
- Sleep (Subjective sleep Quality)(Baseline (pre), 6 weeks (post), 6 months (followup))
- Social stress - heartrate(Baseline (pre), 6 weeks (post))
- Brain derived neurotrophic factor (Serum-BDNF)(Baseline (pre), 2 weeks, 6 weeks (post), 6 months (followup))
- Sleep related personality traits(Baseline (pre), 6 weeks (post), 6 months (followup))
- Body Mass Index (BMI)(Baseline (pre), 6 weeks (post), 6 months (followup))
- Resting Heartrate (HR)(Baseline (pre), 6 weeks (post), 6 months (followup))
- Blood Pressure (BP)(Baseline (pre), 6 weeks (post), 6 months (followup))