| CTRI Number |
CTRI/2024/11/077343 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Jogging and 4-7-8 Breathing Technique in Prehypertensive patients |
|
Scientific Title of Study
|
To Compare The Effect of Jogging with 4-7-8 Breathing Technique and Jogging on Blood
Pressure, SPO2 and Body Mass Index in Prehypertensive Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajveer Singh Bhati |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi Physiotherapy College |
| Address |
Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9664141044 |
| Fax |
|
| Email |
rajveersingh@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yuthika Rao |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Science and Technology, Jaipur |
| Address |
Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area , Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9530096172 |
| Fax |
|
| Email |
physioyuths@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yuthika Rao |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Science and Technology, Jaipur |
| Address |
Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area , Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9530096172 |
| Fax |
|
| Email |
physioyuths@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Science and Technology, RIICO Institutional area, Sitapura tonk road Jaipur, Rajasthan, India 302022 |
|
|
Primary Sponsor
|
| Name |
Rajveer Singh Bhati |
| Address |
64, Bahadur nagar, rishikesh nagar, chainpura, mandore, Jodhpur,Rajasthan 342304 |
| 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 Yuthika Rao |
Mahatma Gandhi Hospital, Jaipur |
Room No 14, Physiotherapy OPD, basement, Mahatma Gandhi
Hospital, Jaipur
Jaipur
RAJASTHAN |
9530096172
physioyuths@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R030||Elevated blood-pressure reading, without diagnosis of hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jogging |
Before jogging, a 10-minute warm-up will be performed. The subjects will be taught jogging same as in group A. After jogging, a 10-minute cool-down will be performed. Frequency of Jogging is
this intervention is performed for 4 days per week for 4 week |
| Intervention |
Jogging with 4-7-8 Breathing technique |
Before jogging, a 10-minute warm-up will be performed. The subjects will be taught jogging for 10 minutes in the 1st week ,15 minutes in
the 2nd week and 20 to 30 minutes in the 3rd - 4th week. , and
After jogging, a 10-minute cool-down will be performed. Frequency of Jogging is
4 days per week. After Jogging the subjects will be taught for 4-7-8 Breathing technique . Frequency of 4-7-8 Breathing Technique is 3 sets (10 times)/session, for 4 days
per week. The following method will be followed for 4-7-8 Breathing Technique
1. The patient will be asked to sit in a comfortable position with hands on lap. 2. They will press the tip of the tongue on the ridge of tissue behind the top, front
teeth and keep it there throughout the breathing cycle. 3. They will breathe in deeply through the nose for 4 counts, hold the breath for 7
counts, and then breathe out slowly through the mouth for 8 counts. 4. They will repeat the breathing cycle.
This Intervention will be performed for 4 days per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subject daignosed with prehypertension range systolic blood pressure reading of
120-139 mmhg or a diastolic blood pressure reading of 80-89 mmhg.(According
to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7).Not involved in any other physiotherapy treatment.
Patients willing to participate.
Able to follow commands. |
|
| ExclusionCriteria |
| Details |
Patient daignosed with systolic Blood pressure greater than 139 mmhg or daistolic bloodpressure reading greater 90 mmhg.Presence of any other respiratory conditions.Presence of any other cardiovascular conditions.Presence of orthopedic conditions such as scoliosis, kyphosis.Presence of neuromuscular conditions such as spinal cord injury, Hearing problem.Unable to regularly implement relaxation exercises. Any kind Of Physical Training. Patient daignosed hypotension. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Body Mass Index
Heart Rate & Blood Pressure
Oxygen Saturation(SpO2)
VO2 Max
|
1st Day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body Mass Index
Heart Rate & Blood Pressure
Oxygen Saturation(SpO2)
VO2 Max |
1st week
2nd week
3rd week
4th week |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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
|
PROCEDURE: - The eligibility of the candidate will be assessed based on inclusion criteria.
- Sixty subjects will be randomly selected, and then the consent form will be filled by eligible candidates. After this, they will be randomly allocated into two groups.
- The demographic data of the patient will be taken Day 1 .
- Heart rate , Spo2 , BMI , Blood Pressure , VO2 max will be measured on day 1(pre test).
GROUP A : This will be performed on 30 subjects. - Before jogging, a 10-minute warm-up will be performed.
- The subjects will be taught jogging for 10 minutes in the 1st week ,15 minutes in the 2nd week and 20 to 30 minutes in the 3rd - 4th week. , and
- After jogging, a 10-minute cool-down will be performed. Frequency of Jogging is 4 days per week.
- After Jogging the subjects will be taught for 4-7-8 Breathing technique .Frequency of 4-7-8 Breathing Technique is 3 sets (10 times)/session, for 4 days per week.
The following method will be followed for 4-7-8 Breathing Technique 1. The patient will be asked to sit in a comfortable position with hands on lap. 2. They will press the tip of the tongue on the ridge of tissue behind the top, front teeth and keep it there throughout the breathing cycle. 3. They will breathe in deeply through the nose for 4 counts, hold the breath for 7 counts, and then breathe out slowly through the mouth for 8 counts. 4. They will repeat the breathing cycle.
GROUP B : This will be performed on 30 subjects - Before jogging, a 10-minute warm-up will be performed.
- The subjects will be taught jogging same as in group A.
- After jogging, a 10-minute cool-down will be performed. Frequency of Jogging is 4 days per week.
|