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临床试验/NCT05276843
NCT05276843Unknown不适用

Efficacy of Selected Exercises on Bone Mineral Density in Post-burn Patients

Eman Mohamed othman1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Bone density measurement

研究概览

简要总结

PURPOSE: to assess the efficacy of Qigong exercise on bone mineral density in post-burned patient.

BACKGROUND: During severe burns, more than 7% of the vertebral bone mineral density (BMD) is lost within 3-6 weeks of the injury and about 3% of the total body bone content is lost during the first 6 months after the injury.

Qigong exercise has been shown to be effective at attenuating declines in BMD and improving both balance performance and balance confidence in healthy middle-aged and older adults.

There are lack in knowledge and information in published studies about the efficacy of Qigong exercise on bone mineral density in post-burned patient.

So, this study will be designed to provide a guideline about the efficacy of Qigong exercise on bone mineral density in post-burned patient.

HYPOTHESES:

It will be hypothesized that:

It was hypothesized that Qigong exercise has no or limited effect in bone mineral density in post-burned patient.

RESEARCH QUESTION: Does Qigong exercise an effect on bone mineral density in post-burned patient?

详细描述

  1. Measurement procedure:

Bone density measurement was conducted before the first session and after two months of treatment.

The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual.

Average bone mineral density = BMC/W (g/cm²).

  • BMC = bone mineral content = g/cm.
  • W = width at the scanned line. Data was graded according to Z score.

Z-score:

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
Single (Participant)

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients were 25-50 years old
  • •had thermal burn injuries of 2nd-3rd degree extended from the lower area of trunk to the lower extremities.
  • •the affected total body surface area of 30-45%.
  • •In the early burn stage (30-45 days in burn units), all patients were subjected to a unified physical therapy program consisted of positioning, range of motion, and gentle stretching exercises.

排除标准

  • •any history of endocrine, metabolic or other systemic diseases
  • •prior or ongoing supplementation with calcium
  • •previous or current bone-specific drugs or diseases affecting bone metabolism
  • •any neurogenic disorder impairing sensory or motor function
  • •use of drugs known to affect the central nervous system or equilibrium
  • •previous brain injury or any disease affecting balance
  • •history of epilepsy
  • •previous or habitual high-intensity exercise
  • •lower extremity arthralgia
  • •lower extremity implant
  • •recent surgeries for heart or spine
  • •acute thrombosis
  • •kidney or bladder stones
  • •serious cardiovascular or cerebrovascular disease.

研究组 & 干预措施

group A

Experimental

receive Qigong exercise in addition to traditional physical therapy program

干预措施: Qigong exercise program (Combination Product)

group B

No Intervention

receive traditional physical therapy program only

结局指标

主要结局

Bone density measurement

时间窗: change in bone mineral density calculated at 8 weeks post treatment minus baseline.

The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual.

次要结局

未报告次要终点

研究者

发起方
Eman Mohamed othman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eman Mohamed othman

professor

Cairo University

研究点 (1)

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