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临床试验/NCT07045792
NCT07045792招募中不适用

Investigating the Effects of Body Awareness Therapy on Functional Capacity, Balance, Sleep Quality and Psychological State in Young Adults With High Stress Levels: A Randomized Controlled Trial

Mustafa Kemal University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
6-Minute Walk Test

研究概览

简要总结

Body Awareness Therapy (BAT) is a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. This planned randomized controlled study will be conducted on young adults with high stress levels. One group will be subjected to BAT and the other group will be the control group. The BAT exercises will be performed in supine, sitting and standing positions. In the BAT group, the exercises will be performed as a group exercise, not individually. After the initial evaluations in both the BAT and control groups, a re-evaluation will be performed at the end of 8 weeks. Functional capacity will be assessed with the 6-minute walk test, static balance with the single-leg balance test (eyes open-eyes closed), dynamic balance with the Y-balance test, psychological status with the Depression-Anxiety-Stress Scale-21 (DASS-21), and sleep quality with the Pittsburgh Sleep Quality Scale. BAT will be performed 2 days per week for 8 weeks and will be continued progressively. This study will examine the effects of BaT on functional capacity, balance, sleep quality, and psychological state in young adults with high stress levels.

详细描述

This study will follow a randomized controlled trial design. The study will be conducted in young adults at the Faculty of Health Sciences, Hatay Mustafa Kemal University.

Based on data reported in the literature, using stress score changes, the effect size for the group x time interaction was calculated to be approximately f=0.36 under the assumption of a repeated measures correlation of 0.50. The ANOVA: Repeated measures, within-between interaction option from the F-test family was used in the analysis. With an effect size of f=0.36, a type I error level (α=0.05), test power of 95%, a repeated measures correlation of 0.50, and a nonsphericity correction ε=1, the power analysis indicated that a total of 28 people were needed, with a minimum of 14 people in each group.

All assessments will be conducted in person by the research team. A comprehensive evaluation of the descriptive information, functional capacity, balance, sleep quality, and psychological status of the study participants is warranted.

Treatment Program Individuals in the BAT group will train 2 days per week for 8 weeks. The training will be conducted by a person who has received BAT training at levels A, B, C and D at the Swedish Institute of Body Awareness (Institutet Basal Kroppskännedom).

Those in the control group will not receive any training and will remain on the waiting list. These patients will also be assessed at baseline and after 8 weeks. In this group, BAT will be applied to the students who want to receive the training after the last measurements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be between 20 and 30 years old
  • Be literate
  • Score 10 or above on the stress subscale of the Depression Anxiety Stress Scale -21
  • Be willing to participate in the study voluntarily

排除标准

  • Individuals with orthopedic, neurological, rheumatological, psychiatric, mental, or any systemic chronic diseases
  • Those with cardiac problems that may prevent exercise
  • Those suspected of being pregnant
  • Individuals with malignancy
  • Individuals with active infection
  • Those who do not regularly attend the treatment program

研究组 & 干预措施

Intervention Group

Experimental

Body Awareness Therapy

干预措施: Body Awareness Therapy (Procedure)

Control Group

No Intervention

No intervention

结局指标

主要结局

6-Minute Walk Test

时间窗: 8 weeks

They will be asked to walk as fast as they can down a 30-meter straight corridor for 6 minutes.

Single Leg Stance Test

时间窗: 8 weeks

The maximum time that individuals can stand on one leg with eyes open and closed will be recorded.

Y Balance Test

时间窗: 8 weeks

During the test, 3 trials will be performed for each leg and the best score will be recorded (right anterior, left anterior, right posteromedial, left posteromedial, right posterolateral, left posterolateral). The maximum reach distance was recorded for each consecutive trial.

Depression Anxiety Stress Scale - 21

时间窗: 8 weeks

Psychological status will be evaluated. The total score for each heading ranges from 0 to 21. Higher total scores indicate higher depression, higher anxiety, and higher stress levels.

Pittsburgh Sleep Quality Index

时间窗: 8 weeks

Sleep quality will be evaluated. The 19 items measure seven subcomponents. Each question is scored between "0" and "3". The total score (0-21) is obtained by adding the seven subscores. According to the total score, those with a score of 5 and below are interpreted as having good sleep quality, and those with a score above 5 are interpreted as having poor sleep quality.

6-Minute Walk Test

时间窗: 8 weeks

They will be asked to walk as fast as they can down a 30-meter straight corridor for 6 minutes.

Single Leg Stance Test

时间窗: 8 weeks

The maximum time that individuals can stand on one leg with eyes open and closed will be recorded.

次要结局

  • International Physical Activity Questionnaire - Short Form(8 weeks)
  • International Physical Activity Questionnaire - Short Form(8 weeks)

研究者

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

Yasemin KARAASLAN

Principal Researcher, Head of Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University

Mustafa Kemal University

研究点 (2)

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