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CTRI Number  CTRI/2023/10/058925 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 20/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of hot and cold arm bath with foot bath on cardiac health among healthy people  
Scientific Title of Study   Comparative study on immediate effect of hot and cold arm bath with foot bath on autonomic variables among healthy individuals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidya K 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Department of clinical naturopathyfirst floor,Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady Dakshina Kannada KARNATAKA 574240 India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  09972571480  
Fax    
Email  krajvidya935@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidya K 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Department of clinical naturopathyfirst floor,Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady Dakshina Kannada KARNATAKA 574240 India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  09972571480  
Fax    
Email  krajvidya935@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujatha K J 
Designation  Vice principal and Dean division of natural therapeutics and hydrotherapy 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Department of clinical naturopathyfirst floor,Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady Dakshina Kannada KARNATAKA 574240 India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  09480401646  
Fax    
Email  drsujathadinesh2@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana 
 
Primary Sponsor  
Name  centre of excellence sdm yoga and nature cure hospital shantivana dharmasthala 
Address  SDM Yoga and Nature Cure Hospital Shanthivana Dharmasthala 574 216 Dakshina Kannada District, Karnataka India. 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidya K  SDM Yoga and nature cure hospital, shantivana  SDM Yoga and nature cure hospital,Shanthivana, Dharmasthala,Near Nethravathi River,
Dakshina Kannada
KARNATAKA 		 9972571480

krajvidya935@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Naturopathy and Yogic sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  EFFECT OF COLD ARM BATH WITH FOOT BATH   GROUP 2 – COLD ARM AND FOOT BATH. Hydrotherapy procedure was as follows. Subjects were instructed to drink a glass of tepid water and sit in an arm and foot bath by Immersing arms in arm bath and legs in foot bathtub. The temperature of the bath was maintained between 55°F to 65°F. The duration of this arm and foot bath was for 20 min.  
Intervention  EFFECT OF HOT ARM BATH WITH FOOT BATH   GROUP 1 – HOT ARM AND FOOT BATH. Hydrotherapy procedure was as follows. Subjects were instructed to drink a glass of tepid water and sit in an arm and foot bath by Immersing arms in arm bath and legs in foot bathtub. The temperature of the bath was maintained between 103°F and 110°F. A blanket was enveloped around the person and bath to prevent cool air from contact with skin and prevent dissipations of heat from the bath. Simultaneously, wet compress placed over head. The duration of this arm and foot bath was for 20 min.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Subjects who are given consent to participate in the study.

 
 
ExclusionCriteria 
Details  1)Systemic illness

2)Substance abuse.

3)Active nicotine abuse.

4)Female subjects during menstruation

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Blood pressure.

Heart rate variability.

 		 Group 1: Intervention group -Subjects will receive Hot arm & foot bath for 15 to 20 minutes.

Group 2: control group- subjects will receive cold arm and foot bath for 15 to 20 minutes.

Subjects assessed for the blood pressure measurement.Subjects assessed for the Heart rate Variability (HRV).The assessments are carried out 5 min before the intervention and immediately within 5 min after the intervention.

 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="25" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   COMPARATIVE STUDY ON IMMEDIATE EFFECT OF HOT AND COLD ARM BATH WITH FOOT BATH ON AUTONOMIC VARIABLES AMONG   HEALTHY INDIVIDUALS.

Hydrotherapy is a type of naturopathy that involves using water in a variety of states, pressures, temperatures, and applications for therapeutic purposes. Immersion baths, underwater massages, foot and arm baths, sitz baths, and whirlpool baths (Jacuzzis) were the hydrotherapeutic procedures that received the greatest research attention.Cold water Immersion (CWI) causes the body to undergo considerable physiological and biochemical changes, including a rise in heart rate and blood pressure.In contrast, during 30 minutes of head-out WI (38.41± 0.04°C), an increase in HR and a drop in SBP and DBP were seen .

Neural factors, as well as others like temperature, hormones, etc., govern cardiovascular functioning. The Autonomic Nervous System (ANS), which is primarily responsible for maintaining and regulating cardiac functions like systolic and diastolic blood pressure (SBP and DBP) and heart rate, is one of them (HR).

The effect of water temperature (WT) on HRV was examined in few earlier research. According to the short-term estimate of HRV time-domain analysis, hydrostatic pressure and cold-induced peripheral vasoconstriction during CWI are also thought to help restore cardiac parasympathetic activation. The impact of water immersion temperature on variability in heart rate.WI significantly alters how the autonomic nerve system functions. Heart rate variability(HRV) was examined in relation to three different water temperatures (33°C, 36°C, and 39°C). Each water temperature had distinct impacts on Core Body Temperature (CBT), Peripheral Temperature (PT), and HRV during Water Immersion(WI). For therapeutic purposes, the water’s temperature is essential .A crucial connection exists between cognitive function, HRV, and prefrontal brain function, and it has significant effects on both physical and mental health.Healthy human heart rate (HR) is regulated by physical, emotional, and cognitive activity, and heart rate variability (HRV) refers to the physiological oscillations that cause varying beat-to-beat variations in HR. The most accurate and accessible indices of autonomic control and vagal activity may be HR and HRV.However, despite the widespread use of Hot arm and foot bath and cold arm and foot baths, the precise physiological reactions of hot arm and foot bath have been studied  and precise physiological reactions of cold have not been studied.This is the first comparative study on immediate effect of hot and cold arm bath with foot bath on autonomic variables among healthy individuals conducted to better understand the underlying physiological mechanisms. Few studies have been conducted on numerous naturopathic treatment techniques to investigate their physiological effects. Before using them as therapeutic agents, it is essential to understand the underlying mechanisms. Therefore, the present study aims to investigate the comparative study on immediate effect of hot and cold arm bath with foot bath on autonomic variables among healthy individuals.   OBJECTIVE:

 To study Comparative study on immediate effect of hot and cold arm bath with foot bath on autonomic variables among healthy individuals.

  To assess the blood pressure.

   To assess the Heart rate variability.

Method

Group 1: Intervention group -Subjects will receive Hot arm and foot bath for 15 to 20 minutes.

 Group 2: control group- subjects will receive cold arm and foot bath for 15 to 20 minutes.

 Pre assessment 5 minutes prior to the intervention and Post assessments will be done immediately within 5 min after the intervention. The data collected will be tabulated and analyzed using appropriate statistical methods.

 
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