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临床试验/NCT06937008
NCT06937008已完成不适用

Effect of Whole Body Vibration on Balance in Post Menopause Diabetic Women

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
OSI

研究概览

简要总结

Postmenopausal diabetic women have significant balance deficits and increased fall risk. Whole-body vibration may improve balance in these population but needs further research. The purpose of the current study was to determine the effect of whole-body vibration on balance in postmenopausal diabetic women.

详细描述

Background: Menopause is characterized by reduced androgens produced by ovaries, which negatively affect women health including metabolism and quality of life (QoL) and sexual function. Purpose: This study investigates the effect of whole-body vibration on balance and QoL in postmenopausal diabetic women. Methods: Forty postmenopausal women with diabetic neuropathy will participate in this study aged from 50 to 65 years. They will be randomly distributed into two equal groups: Group A (study group): will receive whole body vibration (WBV) and balancing exercise. Group B (control group): will receive the same balancing exercises as group A. The treatment will be performed 3 times per week for 12 weeks. Dynamic balance will be assessed by Biodex Balance System (BBS) that assesses (Overall stability index [OSI], anteroposterior stability index [APSI] and mediolateral stability index [MLSI)], Berg Balance test (BBT) and Time up and go test (TUG). Quality of life will be assessed by menopous specific in Quality of Life questionnaire before and after the treatment.

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

  • •Inclusion Criteria:
  • •Patients were examined by a gynaecologist before the study and were selected according to the following criteria:
  • •Diabetic postmenopausal women who suffered from peripheral neuropathy
  • •Their ages ranged from 50 to 65 years.
  • •Body Mass Indices (BMI) ≤ 30kg/m2
  • •They were medically stable.

排除标准

  • •Patients were examined by a gynaecologist before the study and were excluded if they had:
  • •Inner ear disturbance.
  • •Musculoskeletal problems.
  • •Active tuberculosis and tumours.
  • •Implanted cardiac rhythm devices.
  • •Any hormonal replacement therapy or drug treatment that could affect normal metabolism of musculoskeletal system.
  • •Habitual exercise or participate in any supervised exercise.
  • •Hypo- or hyperparathyroidism, renal, liver, or chronic disease.

研究组 & 干预措施

WBV group

Experimental

consisted of twenty postmenopausal women with diabetic neuropathy who received whole body vibration and balancing exercise (three times per week for 12 weeks).

干预措施: Whole body vibration (Other)

WBV group

Experimental

consisted of twenty postmenopausal women with diabetic neuropathy who received whole body vibration and balancing exercise (three times per week for 12 weeks).

干预措施: Balance training (Other)

Balance group

Active Comparator

consisted of twenty postmenopausal women with diabetic neuropathy who received the same balancing exercises as for group A (three times per week for 12 weeks).

干预措施: Balance training (Other)

结局指标

主要结局

OSI

时间窗: pre and after 3 months of intervention

TThe BBS measures, in degrees, the tilt about each axis during dynamic conditions and calculates a medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and an overall stability index (OSI). The OSI score is believed to be the best indicator of the overall ability.

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

Ahd Tarek Helmy el Dears

Department of Physical Therapy for Women's Health Faculty of Physical Therapy Cairo University

Cairo University

研究点 (1)

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