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CTRI Number  CTRI/2024/06/069022 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect Hot Foot Immersion and Ice Massage on Hypertension  
Scientific Title of Study   Effect of Hot Foot Immersion And Ice Massage to Head and Spine on Autonomic and Hemodynamic Variables in Hypertensive individuals-Three arm study 
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 Naveen KumarD 
Designation  PG Student 
Affiliation  SDM college of Naturopathy and Yogic sciences 
Address  Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina Kannada KARNATAKA 574240 India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7026281189  
Fax    
Email  drnaveenhbh2011@hmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naveen KumarD 
Designation  PG Student 
Affiliation  SDM college of Naturopathy and Yogic sciences 
Address  Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina Kannada KARNATAKA 574240 India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7026281189  
Fax    
Email  drnaveenhbh2011@hmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetha B Shetty 
Designation  Professor and Dean Division of Nutrition and Dietetics 
Affiliation  SDM college of Naturopathy and Yogic sciences 
Address  Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina Kannada KARNATAKA 574240 India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9449714767  
Fax    
Email  gbsujire@gmail.com  
 
Source of Monetary or Material Support  
Sri Dhrmasthala Manjunatheshwera Yoga and Nature Cure Hospital,Shanthivana,dharmasthala,Belthangadi,Dakshina kannada-574216 karnataka india 
 
Primary Sponsor  
Name  Dr Naveen Kumar D 
Address  Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina Kannada KARNATAKA 574240 India 
Type of Sponsor  Other [Self] 
 
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 Naveen Kumar D  Sri Dharmasthala Manjunatheshwara Yoga and Natre Cure Hospital,Shanthivana  COE, Department of natural Therapeutics Shanthivana,Dharmasthala, Beltangadi,Dakshina Kannada
Dakshina Kannada
KARNATAKA 
7026281189

drnaveenhbh2011@hmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hot Foot Immersion  The subjects are directed to sit in a chair and immerse both legs in a plastic bucket filled with warm water. The waters temperature is kept between 37°C and 41°C, and the inter-vention lasts for 20 minutes. The lower limbs are immersed to a depth of approximately 20 cm.13 L of hot (42.0°C) water was prepared to immerse the lower legs up to 18 cm from the sole. This was done while sitting for 15 minutes with both legs soaked. The water was wiped away with a towel after the footbath was finished  
Intervention  Hot Foot Immersion and Ice Massage to Head and Spine  The subjects are directed to sit in a chair and immerse both legs in a plastic bucket filled with warm water. The waters temperature is kept between 37°C and 41°C, and the intervention lasts for 20 minutes. The lower limbs are immersed to a depth of approximately 20 cm, 13 L of hot (42.0°C) water was prepared to immerse the lower legs up to 18 cm from the sole of the foot. This was done while sitting for 15 minutes with both legs soaked. The water was wiped away with a towel after the footbath was finished(34) The subjects are instructed to lie face down on a massage table. The rubber bag filled with ice (1°C-2°C) and applies it to the head for the crown, back, right and left sides. The therapist then applies the ice bag to the spine by continuously moving it to the cervical, thoracic, and lumbar and sacral regions with continuous longitudinal displacements. This process is repeated for a total of 20 minutes. Once the ice massage is complete, the therapist wipes off any remaining water with a towel. 
Comparator Agent  Ice Massage to Head and Spine  The subjects are instructed to lie face down on a massage table. The rubber bag filled with ice (1°C-2°C) and applies it to the head for the crown, back, right, and left sides. The therapist then applies the ice bag to the spine by continuously moving it to the cervical, thoracic, and lumbar, and sacral regions with continuous longitudinal displacements. This process is repeated for a total of 20 minutes. Once the ice massage is complete, the therapist wipes off any remaining water with a towel. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Age 35-65 years.
2 Both genders.
3 Subjects diagnosed with hypertension with or without medications.
4 Essential hypertension.
 
 
ExclusionCriteria 
Details  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.
5)Female subjects during their menstrual cycle, as menstruation is known to influence the circulatory and humoral dynamics
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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)
Double product, Rate pressure product (RPP) 
The baseline will be taken 5 minutes before the intervention.
Post data will be taken 5 minutes after the intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
Ankle-brachial index  Baseline,5 minutes after the intervention  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 2 
Date of First Enrollment (India)   01/07/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

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 circulationOne 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

 
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