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临床试验/NCT04211493
NCT04211493Unknown不适用

Empowering Health: Acute Psychological Effects of a Single Electromyostimulation-Whole-Body-Workout in Participants With Depression

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
34
试验地点
1
主要终点
Change in depressive symptoms

研究概览

简要总结

The study investigates the acute psychological effects of a whole-body-workout using Electromyostimulation (EMS) in participants with depression and healthy individuals.

详细描述

EMS-whole-body-workouts are less time-consuming and effort-intensive but generate physical effects which are comparable to conventional strength training. Therefore EMS could lower the barrier to physical activity. The present study focusses on acute psychological effects of an EMS workout - especially with regard to the reduction of depressive symptoms. Physical activity is notably important for patients with depression and shows multiple positive psychological and physical effects. But due to disease-related factors like lethargy, physical activity is far too rarely implemented. Therefore EMS-whole-body-workouts could provide an opportunity to generate positive psychological effects through a less (subjective) cost-intense strength training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants are not aware of the study hypothesis.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Subject familiarized with experimental procedure and had given written informed consent
  • •Depression, according to ICD-10
  • •BDI-II Score ≥ 14
  • •Able to understand German
  • •Reachability of participant for the two training sessions

排除标准

  • •Contraindications for physical exercise
  • •Contraindications for EMS-use
  • •Current EMS-use
  • •Pregnancy
  • •Borderline personality disorder
  • •Bipolar Disorder
  • •Schizophrenia
  • •Anorexia Nervosa, Bulimia Nervosa
  • •Acute suicidality
  • •Substance dependencies with actual consumption (except nicotine)

研究组 & 干预措施

Experimental-Condition

Experimental

20 minutes whole-body-workout with simultaneous muscle stimulation (EMS).

Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are simultaneously stimulated by those external electrodes with medium level (5) of stimulation intensity.

干预措施: whole-body-workout (Behavioral)

Experimental-Condition

Experimental

20 minutes whole-body-workout with simultaneous muscle stimulation (EMS).

Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are simultaneously stimulated by those external electrodes with medium level (5) of stimulation intensity.

干预措施: EMS (Device)

Placebo-Condition

Placebo Comparator

20 minutes whole-body-workout without simultaneous muscle stimulation (EMS).

Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout they are stimulated with the lowest possible stimulation intensity (1). This is perceptible as a slight tingling sensation but the impulse intensity lies below the muscular threshold and therefore generates no muscular activity.

干预措施: whole-body-workout (Behavioral)

Placebo-Condition

Placebo Comparator

20 minutes whole-body-workout without simultaneous muscle stimulation (EMS).

Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout they are stimulated with the lowest possible stimulation intensity (1). This is perceptible as a slight tingling sensation but the impulse intensity lies below the muscular threshold and therefore generates no muscular activity.

干预措施: EMS-Placebo (Device)

结局指标

主要结局

Change in depressive symptoms

时间窗: From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session

Depressive symptoms are measured using the State-Scale of the State-Trait Depression Scales (STDS) by Spaderna, Schmukle \& Krohne (2002). The SDTS State-Scale has two subscales with each 5 likert scaled items with values ranging from 1 to 4. Higher scores mean a worse outcome for the first subscale and a better outcome for the second subscale.

次要结局

  • Change in anxiety symptoms(From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session)
  • Change in general self-efficacy(From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session)
  • Change in intention for physical activity(From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session)
  • Change in self-efficacy regarding physical activity(From directly before the intervention to immediately after the intervention - both: before/after the EMS-training-session and before/after the Placebo-session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonia Bendau

Principal Investigator

Charite University, Berlin, Germany

研究点 (1)

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