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临床试验/NCT04499417
NCT04499417Unknown不适用

Psychological and Physical Effects of an 8-Week Electromyostimulation-Whole-Body-Workout

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年7月19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
72
试验地点
1
主要终点
Acute change of subjective well-being.

研究概览

简要总结

The study investigates the midterm, longterm and acute psychological and physical effects of an 8-week whole-body-workout using Electromyostimulation (EMS) in 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 psychological and physical effects of an 8-week EMS workout. Physical activity is notably important for mental and physical health, but is on average far too rarely implemented. Therefore EMS-whole-body-workouts could provide an opportunity to generate positive psychological and physical 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
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and Outcomes Assessors are not aware of the study hypothesis / the condition.

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
  • •Able to understand German
  • •Reachability of participant for the eight training sessions

排除标准

  • •Contraindications for physical exercise or EMS-use
  • •Current EMS-use or intense regular exercise (> 60 min / week)
  • •Pregnancy
  • •Current presence of any mental disease
  • •Acute suicidality
  • •Substance dependencies with actual consumption (except nicotine)

研究组 & 干预措施

Experimental-Condition

Experimental

8 weeks x weekly 20 minutes whole-body-workouts 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: Electromyostimulation Whole-Body-Workout (Device)

Sham-Condition

Sham Comparator

8 weeks x weekly 20 minutes whole-body-workouts 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 the muscles are not actually stimulated by EMS.

干预措施: Electromyostimulation Sham Whole-Body-Workout (Device)

结局指标

主要结局

Acute change of subjective well-being.

时间窗: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.

• Subjective well-being is measured using a visual analogue scale (0-100%, higher value = better outcome).

Acute change of subjective relaxation.

时间窗: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.

• Subjective relaxation is measured using a visual analogue scale (0-100%, higher value = better outcome).

Change of acute symptoms of anxiety and depression.

时间窗: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.

• The State-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-State; Renner, Hock, Bergner-Köther \& Laux, 2018) is used to assess acute symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.

次要结局

  • Change in general self-efficacy(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)
  • Change in physical parameters: heart rate variability.(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)
  • Change in attitudes regarding physical activity (intentions for physical activity, self-efficacy regarding physical activity)(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)
  • Mid-/longterm changes in depressive symptoms.(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)
  • Mid-/longterm changes in anxiety symptoms.(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)
  • Mid-/longterm changes in affect-related psychological variables.(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)
  • Mid-/longterm changes in positive and negative affect.(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)
  • Change in physical parameters: hand force.(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)
  • Change in physical parameters: leg strength.(Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).)

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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