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临床试验/NCT06057701
NCT06057701已完成不适用

Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women

Cairo University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-41)

研究概览

简要总结

the present study examined the effect of different types of exercises for improving the age-related hyperkyphotic curve of postmenopausal women and also examined how it affects diaphragmatic excursion and respiratory function. Increasing the respiratory functions for elderly will act as a preventive method against nowadays chest diseases.

详细描述

The study was conducted to examine the effect of exercises on diaphragmatic excursion in postmenopausal kyphotic women.

Design of study:

A prospective, randomized, single-blind, pre-post-test, controlled trial. The study followed the Guidelines of Declaration of Helsinki on the conduct of human research. Ethical approval was obtained from the institutional review board at Faculty of physical therapy, Cairo University before study commencement (no.P.T,REC/012/003800).

This study was carried on forty postmenopausal women clinically diagnosed with thoracic kyphosis. They selected randomly from the outpatient clinic of El Kaser El-Einy University Hospital, Cairo University. Their ages ranged from 50-60 years.

Randomization of sample selection was achieved using closed envelop way. Classification of the sample by simple random way into two groups equal in number, twenty for each group by using forty closed envelop, each twenty envelop contained a name of a group from the two groups (Group A) or (Group B) and asking each woman to choose one envelop from them, each woman attended to the group according the name of the group written in her envelop.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All postmenopausal women suffering from thoracic kyphosis.
  • Their thoracic kyphosis (Cobb's) angles were more than 45 degrees.
  • Their age ranged from 50-60 years old.
  • Their BMI were >25 and <30 kg/m2.

排除标准

  • All patients with comorbidities such as cardiac disease and chest diseases as pulmonary fibrosis.
  • Patients with previous trauma to the spine, pelvis and lower limbs.
  • Patients with a previous history of spinal surgery (such as spinal fusion surgery, vertebroplasty, or kyphoplasty).
  • Patients with congenital spinal deformities and scoliosis.
  • Patients with a history of spinal tumors, ankylosing spondylitis, osteoporosis and other spondyloarthritis.
  • The patients received medications that might affect the neuromuscular functions at least three months before or during the study course.
  • Patients suffered from mental or psychological disorders.
  • Patients suffered from inflammatory diseases such as rheumatoid arthritis or polymyalgia rheumatic.

结局指标

主要结局

Quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-41)

时间窗: period of treatment is for 12 weeks

The QUALEFFO-41 is a self-administered, disease specific questionnaire used frequently in clinical research. It possesses five domains (41 items in total): pain (5 items), physical function (17 items), social function (7 items), general health perception (3 items) and mental function (9 items). The total QUALEFFO score is calculated as a sum of all answers to items and then linearly transformed on the scale 0-100. The worse the HRQOL condition is, the higher the score gets. The actual score was calculated by the summation of all questions answers, the lowest possible score was 41, the score range was 164 (41 subtracted from 205)

flexicurve ruler

时间窗: period of treatment is for 12 weeks

A flexible curve ruler was used to measure the kyphosis angle. The adjustable curve is one of the non-invasive methods for kyphosis and lordosis angle assessments in the sagittal plan.

Diaphragmatic excursion

时间窗: period of treatment is for 12 weeks

To measure diaphragmatic excursion, an ultrasonography device was applied with a probe frequency of 2-5 MHz. The right hemi-diaphragmatic excursion was assessed during deep inspiration and deep expiration

Pain assessment scale

时间窗: period of treatment is for 12 weeks

Visual analogue scale (VAS) is the most common pain scale for quantification of endometriosis-related pain and skin graft donor site-related pain. A review came to the conclusion that VAS was one of the best adapted pain scales for pain measurement for research purposes.The scale described by the researcher to patients in order to make its use easy. The patients will chose a value from numerized values from 0-10 printed on the scale, 0 (indicates no pain) while 10 (indicates maximum pain) and in between the values are classified.

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

Samia Samir Rashed

principal investigator

Cairo University

研究点 (2)

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