| 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
|
|
|
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
|
|
|
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 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 |