Association of Functional Capacity with Quality of Life Among Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- 6-Minute Walk test, Menopause-specific quality of life questionnaire (MENQOL), World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)
研究概览
简要总结
SUMMARY
Background- All women experience a non-pathologic condition known as menopause. Postmenopausal women suffer from various physical, vasomotor and psychiatric problems due to hormonal changes.
Loss of functional capacity (FC) is a common feature of aging in postmenopausal women. There are researches which shows there is decline in FC among postmenopausal women. Among all the method of functional capacity evaluation, 6-minute walk test is used widely due to its simplicity and easy to use.
Menopausal symptoms have a significant impact on quality of life (QoL) of postmenopausal women. Factors such as severity of menopausal symptoms, duration negatively affect QoL. There are evidences which shows negative relation between QoL and menopausal symptoms. Decrease in QoL also associated with lower values in physical component in older adults.
Need of the Study-There are researches which shows decline in FC and QoL among postmenopausal women. There is evidence that FC is associated with QoL among older adults.
To the best of our knowledge no study has evaluated relationship between FC and QoL among postmenopausal women.
Menopause-specific quality of life questionnaire (MENQOL) is a reliable tool to measure the influence of menopausal symptoms on QoL among postmenopausal women but is unavailable in Hindi language. So, there is need to translate the MENQOL questionnaire in Hindi language.
**Aim-**To study the association of functional capacity with quality of life among postmenopausal women.
Methodology-
**Outcome measure-**6-MWT, MENQOL, WHOQOL-BREF.
**Variables-**Functional capacity, Quality of life.
**Method of translation-**original MENQOL will be download from “Mapi Research Trust†and approval will be taken by accepting the agreement for questionnaire translation in Hindi language. Steps will be -
1. Forward translation
2. Backward translation
3. Test on participants
4. Proofreading
· Validation of Hindi translated questionnaire.
Protocol for assessment of functional capacity and quality of life-
The participants who will fulfill the selection criteria of the criteria of the study will be selected and all the demographic details will be obtained. Written Informed consent will be provided after explaining the procedure to all the participants.
Educate participants about both the questionnaires and rate them accordingly to their experiences.
· MENQOL (Hindi) – For evaluation of QoL
· WHOQOL-BREF (Hindi) – For evaluation of QoL
Then after educate about 6-MWT procedure to the participants. For this step-
Pre-test measurements (Heart rate, Blood pressure, Spo² and Rate of Perceived Exertion) will be taken.
Then participants will walk on 30-meter straight walkway free from obstacle for 6 min. in their normal pace.
After 6 minutes, record after measurements and distance covered by the participants.
Find association between FC and QoL.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Postmenopausal women; with absence of menstruation from last 1 year and their menopausal status will be confirmed by asking series of questions, Age 40-60 years, Absence of any acute disease in 6 weeks preceding the study, Body Mass Index 18.5-24.9kg/m2.
排除标准
- •Any use of medications or documented conditions that may affect the study outcomes such as cardiovascular, musculoskeletal, neurological, metabolic or impaired sensation.
- •participants with Systolic blood pressure less than 100mmHg and greater than 139mmHg and diastolic blood pressure less than 60mmHg and greater than 89mmHg, resting heart rate less than 60bpm and greater than 99bpm and participants who are unable to follow commands, Smoker, History of COVID-19, Recent pregnancy in last 2 years, History of any major surgery in last 2 year, Any history of trauma in last 1 year, Women involved in any kind of regular exercise.
结局指标
主要结局
6-Minute Walk test, Menopause-specific quality of life questionnaire (MENQOL), World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)
时间窗: Baseline
次要结局
- Rate of Perceived Exertion(This is a one this study so we have collect the data on baseline.)
研究者
km Priyanka Gautam
Chhatrapati Shahu Ji Maharaj University, Kanpur