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临床试验/NCT07242651
NCT07242651尚未招募不适用

Effect of Tension and Trauma Releasing Exercises on Quality of Life and Sleep in Patients With Hypertension

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Quality of life ,assessed by SF12

研究概览

简要总结

The aim of this study is to investigate the effect of Tension and Trauma Releasing Exercises (TRE) on the quality of life and sleep in hypertensive patients. Participants will perform a series of supervised TRE sessions, and their sleep quality, and quality of life will be assessed before and after the intervention to determine any potential improvements related to the exercise.

详细描述

Forty females have had essential hypertension for at least five years. They will be recruited from the outpatient clinic at physical therapy, Cairo university.

The patients of this study will be randomly assigned into 2 equal groups (n=40):

Study Group A: (20 patients) Will receive Tension and Trauma Releasing Exercises in addition to medical treatment programme.

Control Group B: (20 patients) will receive only the Medical treatment programme.

The program of treatment for the study group will be applied 30 minutes per session , with a maximum of 15 minutes of neurogenic tremors, 3 times per week for 8 consecutive weeks.

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
None

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Participants will be between 50 and 65 years of age.
  • •The BMI of patients will range between 30 and 34.
  • •Patients included in the study were diagnosed with essential hypertension for at least five years.
  • •The patients will be in stage 1 hypertension under medical control, characterized by systolic blood pressure ranging from 140 to 159 mmHg and diastolic blood pressure ranging from 90 to 99 mmHg.

排除标准

  • •Patients suffering from any unstable cardiovascular condition, such as uncontrolled arrhythmias or recent myocardial infarction.
  • •Patients are diagnosed with secondary hypertension.
  • •Patients with cognitive or physical impairments that prevent them from following instructions.
  • •e) Patients who are taking beta-blockers and alpha-blockers because these medications may affect heart rate.
  • •f) Individuals with endocrine disorders or any condition known to influence hormonal levels.
  • •g) Patients are smokers. h) Malignant hypertension.

研究组 & 干预措施

"Control Group"

No Intervention

Participants in this group will continue their usual medical treatment for hypertension without any additional exercise intervention. They will receive the same assessments for sleep quality, and quality of life as the experimental group.

"TRE Exercise Group"

Experimental

Participants in this group will perform supervised Tension and Trauma Releasing Exercise (TRE) sessions in addition to their usual medical treatment for hypertension. The TRE sessions will be conducted three times per week for eight weeks, and each session will last approximately 30 minutes. The exercises aim to promote relaxation, reduce tension, and improve sleep quality, and quality of life.

干预措施: Tension and trauma releasing exercises (Behavioral)

结局指标

主要结局

Quality of life ,assessed by SF12

时间窗: Baseline and after 8 weeks of intervention

Change in SF-12 physical and mental component summary scores from baseline to 8 weeks.

Sleep quality, assessed by the Pittsburgh Sleep Quality Index (PSQI).

时间窗: Baseline and 8 weeks after the start of the intervention

Change in global PSQI score from baseline to 8 weeks. PSQI will be administered to assess sleep quality .

次要结局

  • Blood pressure - Systolic and Diastolic (mmHg) ,assessed by mercury sphygmomanometer(Baseline and 8 weeks after the start of the intervention)
  • Heart rate ,assessed by pulse oximeter(Baseline and 8 weeks after the start of the intervention)
  • Depression and anxiety ,assessed by Hospital Anxiety and Depression Scale (HADS)(Baseline and 8 weeks after the start of the intervention)
  • Rate Pressure Product measurement(Baseline and 8 weeks after the start of the intervention)

研究者

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

Youmna Gamal Abdelmouty Elsayed

BSc. in Physical Therapy, Cairo University, 2018

Cairo University

研究点 (1)

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