Hot Water Therapy for the Treatment of Menopause-related Hot Flashes and Other Symptoms: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Greene climacteric questionnaire
研究概览
简要总结
The purpose of this research is to determine whether hot water therapy (i.e. taking prolonged hot baths on multiple consecutive days) decreases hot flash symptoms and improves mood in women who are undergoing or who have underwent menopause. It is hypothesized that women who undergo hot water therapy will have reduced hot flash symptoms and improved mood.
Initial tracking period: Women who volunteer to participate in this study will be asked to track the frequency and intensity of their hot flash and other menopause-related symptoms for an initial two week period. Afterwards, they will start their heat therapy program.
Physiological assessments: On days 1, 7, and 13 of the heat therapy sessions, the participants will enter a climate controlled room to have their thermoregulatory responses assessed. This will consist of slowly walking on a motorized treadmill in 99.5°F (37.5°C) and 30% relative humidity conditions, for 30 min, after which the humidity in the climate chamber will be progressively increased until their core temperature begins to increase (~2 hour total time). Before and/or during these trials, core temperature, heart rate, whole-body sweat losses, thermal comfort, local sweat rate, and skin blood flow will be measured, and a 6 ml (~1 tsp) blood sample will be taken, to assess how the participants respond to the heat stress. These sessions should take less than 3 hours to complete.
Hot water therapy sessions: Upon enrolling in the study, the participants will be assigned to one of two groups: water bathing at 105°F or 97°F in the lab. On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves to a water level at the shoulders for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min).
Post-intervention tracking period: after completing the heat therapy sessions, the participants will be asked to continue to take baths at home once every 4 days for 1 month. During this time, the participants will be asked to record the intensity and frequency of their hot flashes daily and other menopause-related symptoms weekly. At the end of this month the participants will be given a final exit survey, in order for them to provide the researchers information about their experience participating in the study.
详细描述
Menopause is the time at which menstruation stops and perimenopause is the period before, characterized by a continuous reduction in estrogen and progesterone levels in the blood. Concurrently, the reductions in estrogen leads to a rise in another hormone, orexin. The reduction in circulating estrogen and progesterone and the increase in circulating orexin have been demonstrated to play a major role in menopause-related hot flashes and night sweats, known as vasomotor symptoms (VMS), as well as other symptoms such as mood disorders.
While hormonal replacement therapy remains the most effective defense against VMS, there has been a progressive decline in its prescription due to side effects such as uterine bleeding, increased risk of thromboembolism, as well as increased rates of gallbladder, breast, endometrial, and urinary cancers, highlighting the need for alternative non-hormonal treatments.
Exercise, and specifically the thermoregulatory benefits of exercise (i.e. increased sweating and skin blood flow, as well as reduced core temperature), improves vasomotor symptoms in women going through menopause. Heat acclimation/heat therapy improves thermoregulatory responses by more than twice as much as exercise alone, however, to date, no studies have investigated the effects of heat acclimation on menopause-related vasomotor symptomology.
Accordingly, the purpose of this study will be to examine whether hot water bathing improves vasomotor symptomology, with the guiding hypothesis that hot water bathing will reduce vasomotor symptomology.
Recruitment For this study, we will aim to recruit 100 women who have either undergone or who are undergoing menopause and who self-report experiencing vasomotor symptomology.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-reported menopause-related hot flashes
排除标准
- •Diagnosed with a cardiovascular illness that precludes them from taking part in exercise
结局指标
主要结局
Greene climacteric questionnaire
时间窗: One month pre therapy through to one month post therapy
This is a standard questionnaire used to quantify the intensity of 21 common menopause-related symptoms. The score for each question ranges in intensity from 0 (not at all) to 3 (extremely).
Daily hot flash diary
时间窗: One month pre therapy through to one month post therapy
Based on industry-standard hot flash diaries, this tracks the number and intensity (where 1 is none and 10 is extreme) of hot flashes, night sweats, and mood disruptions that the participants feel.
次要结局
- Core temperature(Day zero, six, and 12 of therapy)
- Skin blood flow(Day zero, six, and 12 of therapy)
- Maximum skin wettedness(Day zero, six, and 12 of therapy)
- Blood plasma volume(Day zero, six, and 12 of therapy)
- Sweat rate(Day zero, six, and 12 of therapy)
- Reproductive hormone levels (estrogen, progesterone, luteinizing hormone, orexin)(Day zero, six, and 12 of therapy)