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临床试验/CTRI/2024/07/071291
CTRI/2024/07/071291尚未招募2/3 期

Development, Validation and Pilot testing of a Multidimensional Rehabilitation Protocol for Post-menopausal women

Poornima Maurya1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
Menopause Rating Scale

研究概览

简要总结

ABSTRACT Background: Menopause is a normal aging phenomenon in women which marks the end of the reproductive phase. The overall prevalence of menopausal symptoms in all domains was reported as 87.7% which includes hot flushes, cognition, autonomic nervous disorders, sleep disturbances, mood changes, anxiety, depressive symptoms, urogenital symptoms, fatigue, limb pain and paraesthesia, and joint pain, etc. Estrogen is believed to be potent regulators of mind and body. Low levels of estrogen during menopause is responsible for the impairments which leads to decrease in overall quality of life of a post-menopausal women. Purpose: The study aimed to develop, validate and pilot testing a multidimensional rehabilitation protocol for post-menopausal women. Methods: This study comprises two phases. First phase is concerned with the protocol development and validation process. This phase includes Delphi method which will evaluate the content validity of the protocol. Second phase consists of pilot testing of the protocol for post-menopausal women. Data Analysis: The collected data will be analyzed by using SPSS 16.0 version. Normality will be assessed by Kolmogrov smirnov test. If the data is found to be normally distributed, it will be presented as mean+SD and pearson correlation test will be used to analyse. If the data is found to be not normally distributed, it will be presented as Median (Interquartile Range) and Spearman’s correlation test will be used to analyse it. Result: The protocol has been validated by a group of multidisciplinary experts. 7 experts responded and evaluated each item of the protocol and suggested modifications. The content Validity of each item was found to be between 0.86 and 1 whereas the S-CVI by average method was found to be 0.93 which was above the satisfactory level as suggested by Lynn i.e. above 0.83. Keywords: menopause, hot flushes, cognition, quality of life

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Age ≥ 45 years Menopause ≥ 1 year Females experiencing menopausal symptoms evaluated using Menopause Rating Scale (MRS).

排除标准

  • Hormonal Replacement Therapy Lipid lowering drugs Thyroid Diabetes Any Hormonal disorder Any neurological disorder Any acute or chronic musculoskeletal inflammatory condition Prior or current diagnosed depression, anxiety, sleep disorder Any psychological illness Recent gynecological surgery Hypertension and taking anti-hypertensive drugs.

结局指标

主要结局

Menopause Rating Scale

时间窗: Baseline, 2nd week, 4th week

R-R Interval

时间窗: Baseline, 2nd week, 4th week

Sympathetic Skin Response (SSR)

时间窗: Baseline, 2nd week, 4th week

次要结局

  • Hot Flash Related Daily Interference Scale (HFRDIS)(Montreal Cognition Assessment (MoCA))

研究者

发起方
Poornima Maurya
申办方类型
Other [(self)]
责任方
Principal Investigator
主要研究者

Poornima Maurya

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

研究点 (1)

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