跳至主要内容
临床试验/NCT06880783
NCT06880783招募中不适用

Effect of Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality in Older Adults With Type II Diabetes: a Randomized Controlled Trial

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年3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
44
试验地点
1
主要终点
6-minute walk test

研究概览

简要总结

To investigate if there is a significant effect of manual diaphragmatic release technique on exercise capacity, sleep quality, chest expansion, ADL, fatigue and quality of life in older adults with type II diabetes.

详细描述

Participants, including both genders, will have a history of Diabetes Type II for more than one year. They will be well controlled with HbA1c≤7. Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m². Patients will follow up on the training program and instructions. They will be medically stable.

研究设计

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

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •History of Diabetes Type II for more than one year.
  • •They will be well controlled with HbA1c≤
  • •Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m².
  • •Patients will follow up on the training program and instructions. They will be medically stable.

排除标准

  • •Chest diseases.
  • •Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm.
  • •History of Myocardial infarction and/or cardiothoracic surgery
  • •Unstable medical status.
  • •Cognitive disability hindering responding to the questionnaires.

研究组 & 干预措施

Study Group

Active Comparator

Participants will receive manual diaphragm release technique combined with deep breathing exercises

干预措施: manual diaphragm release technique (Other)

Study Group

Active Comparator

Participants will receive manual diaphragm release technique combined with deep breathing exercises

干预措施: deep breathing exercises (Other)

Control group

Active Comparator

Participants will receive deep breathing exercises

干预措施: deep breathing exercises (Other)

结局指标

主要结局

6-minute walk test

时间窗: up to 6 weeks

The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Pittsburgh Sleep Quality Index (PSQI)

时间窗: up to 6 weeks

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete

次要结局

未报告次要终点

研究者

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

Mohammed Youssef Elhamrawy

Lecturer of Physical therapy

Beni-Suef University

研究点 (1)

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