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临床试验/CTRI/2024/12/078371
CTRI/2024/12/078371
招募中
1 期

Effect of Aerobic vs Resistance Exercises on Sleep Quality, Insomnia and Functional Capacity among Postmenopausal Women

Ishika Sahu1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年12月29日最近更新:

概览

阶段
1 期
状态
招募中
发起方
Ishika Sahu
入组人数
24
试验地点
1
主要终点
Sleep quality (Pittsburgh Sleep Quality Index)

概览

简要总结

Background:

The global population of postmenopausal women is increasing over 26% of women aged 50 accounted globally in the year 2021, which was at 22% a decade earlier. A woman undergoing the process of menopausal transition goes through lots of physiological changes with her age and faces new symptoms. Upon reaching this phase, more than 50% of women reports problem with their sleep. Sleep disorders have many negative effects on health, including an increase in risk of chronic diseases, decreased daily functioning, decreased mood, reduced use of healthcare and female sexual dysfunction. One of the major symptoms that a woman faces during her menopause is insomnia; poor sleep initiation, maintenance, duration of quality that impairs daily functioning is often described as insomnia; loss of functional capacity among postmenopausal women is also a common feature.

Need of the Study:

There exists evidence that poor sleep quality and insomnia is associated with deteriorated functional capacity. To the best of our knowledge, there is scarcity of researches comparing the effect of resistance exercises vs aerobic exercises on sleep quality, insomnia and functional capacity among postmenopausal women.

Aim:

The aim of this study is to study the effect of aerobic vs resistance exercise on sleep quality, insomnia and functional capacity among postmenopausal women.

Methodology:

In this study, postmenopausal women will be screened first and those fulfilling the inclusion criteria of our study will be selected. The written consent will be signed from the patient to ensure that they are willingly participating in the study. The consent shall be taken before commencement of the study. The participants will be explained about the study procedures. The women will be randomly divided into two groups (A and B) of equal participants i.e. 12 women in each group using block randomization method. Then, the baseline assessments of sleep quality, insomnia and functional capacity will be done; and all the evaluative measures will be done at the start and after the end of the study.

In this study, postmenopausal women will be screened first and those fulfilling the inclusion criteria of our study will be selected. The written consent will be signed from the patient to ensure that they are willingly participating in the study. The consent shall be taken before commencement of the study. The participants will be explained about the study procedures. The women will be randomly divided into two groups (A and B) of equal participants i.e. 12 women in each group using block randomization method. Then, the baseline assessments of sleep quality, insomnia and functional capacity will be done; and all the evaluative measures will be done at the start and after the end of the study.

Protocol for aerobic exercise:

The exercise session will be of 50 minutes that consists of 10 minutes of warm up, 30 minutes on the treadmill and 10 minutes of cool down for three days per week for 4 weeks.  Participants will receive moderate aerobic training in the form of 30 min of treadmill walking. The maximum heart rate (MHR) will be estimated by subtracting 220 by the age of the participant (MHR = 220- age); and the corresponding value to a target heart rate of 65-75% of HR max will be calculated and achieved by the participant. Warm up and cool down will be performed before and after the session respectively.

Protocol for resistance exercise:

6 exercises will be taught to the subjects using the theraband and they are the diagonal flexion, concentration curl, dynamic hug, seated row, side bend and extension of hips and legs. 8 repetitions for 3 set per exercise with 2 minutes rest periods for the subjects in 3 days of a week for 4 weeks will be the time period for the resistance exercises. Warm up and cool down will be performed before and after the session respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

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 one year and their menopausal status will be confirmed by asking series of questions,poor sleep quality with a total score of 5 or greater on the Pittsburgh Sleep Quality Index and a score greater than 8 in the Insomnia Severity Index score,Age 40 to 60 years,Body Mass Index (BMI)18.5-24.9 kg/m2,asymptomatic with stable vitals.

排除标准

  • Participants with systolic BP less than 100 mm Hg and greater than 139 mm Hg; diastolic BP less than 60 mm Hg and greater than 89 mm Hg, Resting Heart Rate less than 60 bpm and greater than 99 bpm, smokers, participants who had undergone hormone replacement therapy,any documented use of medications or any health problem that might affect the outcomes of the study or interfere with the normal ability to walk (such as use of walking aids, impaired cognition or sensation, neurologic, metabolic, cardiac, or orthopedic disease, sleep disorders) ,Any history of previous hospitalization or trauma in the past 6 months, participants who are involved in any kind of regular exercise, sports/athletic events, Pregnancy in the last 2 years.

结局指标

主要结局

Sleep quality (Pittsburgh Sleep Quality Index)

时间窗: Baseline | 4th week

Insomnia (Insomnia Severity Index)

时间窗: Baseline | 4th week

Functional capacity (Six-minute walk test)

时间窗: Baseline | 4th week

次要结局

  • Ratings of Perceived Exertion (RPE)(Baseline)

研究者

发起方
Ishika Sahu
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Ishika Sahu

Chhatrapti Shahu Ji Maharaj University, Kanpur, Uttar Pradesh

研究点 (1)

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