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临床试验/NCT06724744
NCT06724744招募中不适用

Effect of Manual Diaphragmatic Release on Ventilatory Functions and Functional Capacity in Elderly Diabetic Women

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月15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
60
试验地点
1
主要终点
Ventilatory functions

研究概览

简要总结

Evaluate the effect of manual diaphragmatic release on ventilatory functions and functional capacity in elderly diabetic women.

详细描述

Sixty elderly type 2 diabetic women were sourced from the endocrinology outpatient clinic at Mansoura University hospitals in Egypt, with referrals from endocrinologists. Patients were randomly assigned into two groups.

The study group includes 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks, while the control group includes 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes are assessed:

  1. Ventilatory functions (Forced vital capacity and forced expiratory volume in the first second).
  2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).

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)

入排标准

年龄范围
65 Years 至 70 Years(Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Type 2 diabetic for more than 5 years.
  • •Well controlled diabetes with glycated hemoglobin≤7%.
  • •Normal to mild ventilatory functions impairment.
  • •Their ages ranges from 65 to 70 years old.
  • •Their body mass index are less than 30 Kg/m2.

排除标准

  • •Other types of diabetes.
  • •Patients with any other chronic chest diseases .
  • •Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
  • •Rheumatoid arthritis.
  • •Musculoskeletal/ neurological limitations to exercise.

研究组 & 干预措施

Manual diaphragmatic release group

Active Comparator

30 elderly diabetic women participating in manual diaphragmatic release plus aerobic training

干预措施: Aerobic training (Other)

Manual diaphragmatic release group

Active Comparator

30 elderly diabetic women participating in manual diaphragmatic release plus aerobic training

干预措施: Manual Diaphragm Release (Other)

Control group

Active Comparator

30 elderly diabetic women participating in aerobic training only

干预措施: Aerobic training (Other)

结局指标

主要结局

Ventilatory functions

时间窗: At baseline and after 12 weeks

Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second are measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.

次要结局

  • Functional capacity(At baseline and after 12 weeks)

研究者

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

Saad

Assistant Professor of Physical Therapy

Cairo University

研究点 (1)

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