Effect of Hot Foot Immersion And Ice Massage to Head and Spine on Autonomic and Hemodynamic Variables in Hypertensive individuals-Three arm study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Heart rate variability,Hemodynamic variables: Cardiac output (CO), Cardiac index (CI), Stroke volume (SV), Stroke volume index (SVI), pulse pressure (PP), Mean arterial pressure (MAP)
研究概览
简要总结
Hydrotherapy is a therapeutic approach that involves the external or internal use of water in any of its forms (water, ice, steam) for health promotion or the treatment of various diseases. It has been used for centuries as a natural remedy to improve health and well-being. Baths are one of the methods in which water is applied to the human body for therapeutic purposes in hydrotherapy. Baths are complete or partial immersions of the body in various temperatures of water. Foot baths have been a popular practice for centuries, with various temperature ranges being utilized for their therapeutic effects. Among these, thermoneutral temperatures, warm temperatures, and hot temperatures of precisely 33.50°C have been widely employed, owing to their perceived effectiveness in promoting relaxation and improving blood circulation in the feet. Although the benefits of a warm foot bath at 40°C have been observed in hypertensive individuals, its scientific validity has not been established yet. However, heart rate variability (HRV) is an important metric for assessing cardiovascular function and serves as a quantitative marker for autonomic activity. The warm foot bath intervention requires the temperature of the water to be maintained at 40°C for a duration of 15 minutes. Foot baths are known to be an effective method of relaxation, as they increase parasympathetic activity and decrease sympathetic activity , The decrease in total peripheral resistance along with enhanced peripheral circulation. One of the common procedures in hydrotherapy is ice massage is given for a period of 20 minutes. The ice bag was continuously moved during the treatment. The significant
reduction in HR could be the reason for the decrease in BP, BP is determined by both cardiac output and peripheral resistance. Cardiac output is, in turn, determined by HR and stroke
volume. Therefore, HR is one of the determinants of BP, 20-minute.
Grouping
Subjects will be divided into three groups.
Group 1 (n=30).
Group 2 (n=30).
Group 3 (n=30).
Institutional ethical clearance will be obtained prior to the conduct of the study. Informed consent will be obtained from the individuals by explaining the study objectives, methods and intervention and will be obtained from every participant after an appraisal of the study protocol. All the rights of the individual pertaining to the study in their own language.
After selecting the eligible subjects.
Allotment will be done by using a Computer-generated random number.
Group 1: ice massage to head and spine for 20 minutes (n=30).
Group 2: hot foot immersion 20 minutes (n=30).
Group 3: ice massage to head and spine and hot foot immersion for 20 minutes (n=30).
Assessments will be done before and after the intervention
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
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age 35-65 years.
- •2 Both genders.
- •3 Subjects diagnosed with hypertension with or without medications.
- •4 Essential hypertension.
排除标准
- •1 Hypertension with the CAD.
- •2 Hypertension with the previous stroke.
- •3 Hypertension with the CKD.
- •4 Hypertensive patients with ear infection, cervical spondylosis, renal or adrenal involvement.
- •Female subjects during their menstrual cycle, as menstruation is known to influence the circulatory and humoral dynamics.
结局指标
主要结局
Heart rate variability,Hemodynamic variables: Cardiac output (CO), Cardiac index (CI), Stroke volume (SV), Stroke volume index (SVI), pulse pressure (PP), Mean arterial pressure (MAP)
时间窗: The baseline will be taken 5 minutes before the intervention. | Post data will be taken 5 minutes after the intervention.
Double product, Rate pressure product (RPP)
时间窗: The baseline will be taken 5 minutes before the intervention. | Post data will be taken 5 minutes after the intervention.
次要结局
- Ankle-brachial index(Baseline,5 minutes after the intervention)
研究者
Dr Naveen KumarD
SDM college of Naturopathy and Yogic sciences