| CTRI Number |
CTRI/2021/06/034466 [Registered on: 29/06/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [PHYSIOTHERAPY INCLUDING PRANAYAMA TECHNIQUE WHICH CONSIDERED AS SPECIFIC BREATHING TECHNIQUE.] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different physiotherapy treatments essential hypertension. |
|
Scientific Title of Study
|
“A STUDY TO COMPARE THE EFFECTIVENESS OF INSPIRATORY MUSCLE TRAINING VERSUS ALTERNATIVE NOSTRIL YOGA BREATHING ON BLOOD PRESSURE, RESTING HEART RATE AND QUALITY OF LIFE IN ESSENTIAL HYPERTENSION - AN INTERVENTIONAL STUDY†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YAGNIK DAVE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Saurashtra University, Rajkot |
| Address |
5th floor, Cabin 556, Faculty of Physiotherapy, Main building, Marwadi university, Morbi national highway near gauridad, RAJKOT.
Saurashtra University, University Road, Rajkot.
Rajkot
GUJARAT
360005
India |
| Phone |
8511844546 |
| Fax |
|
| Email |
yagnikdave93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
YAGNIK DAVE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Saurashtra University, Rajkot |
| Address |
5th floor, Cabin 556, Faculty of Physiotherapy, Main building, Marwadi university, Morbi national highway near gauridad, RAJKOT.
Saurashtra University, University Road, Rajkot
Rajkot
GUJARAT
360005
India |
| Phone |
8511844546 |
| Fax |
|
| Email |
yagnikdave93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
YAGNIK DAVE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Saurashtra University, Rajkot |
| Address |
5th floor, Cabin 556, Faculty of Physiotherapy, Main building, Marwadi university, Morbi national highway near gauridad, RAJKOT.
Rajkot
GUJARAT
360005
India |
| Phone |
8511844546 |
| Fax |
|
| Email |
yagnikdave93@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
YAGNIK DAVE |
| Address |
MARWADI UNIVERSITY MORBI NATIONAL HIGHWAY RAJKOT |
| 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 |
| YAGNIK DAVE |
Marwadi Institute of Physiotherapy |
Physiotherapy OPD Ground MB00012 floor, Faculty of Physiotherapy, Main building, Marwadi university, Morbi national highway near gauridad, RAJKOT.
Rajkot
GUJARAT |
8511844546
yagnikdave93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAFE SEARCH INDEPENDENT ETHICS 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 |
Alternative nostril yoga breathing |
15 min (one min training followed by one minute rest), 5 days per week for 4 weeks |
| Intervention |
Inspiratory muscle training |
15 minutes (one minute training followed by one minute rest), 5 days per week, for 4 weeks using the Threshold Inspiratory Muscle Trainer |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Stage 1 and stage 2 hypertensive with no change in medications for at least 2 months preceding the study.
Both gender of male and female aged between 30 to 55 years with BMI between 24.01 to 28.08kg/m2.
Those who were willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Secondary hypertension due to liver, heart, renal failure.
Habits of tobacco chewing, smoking and alcohol consumption.
Having disease of Respiratory tract e.g. history of tuberculosis, chronic obstructive airway disease respiratory tract infections.
Athletes, regular pranayama practitioners and patients undergoing any other form of exercise.
Recent cardiovascular events, pulmonary diseases, diabetes mellitus, neuropathies, cardiac arrhythmias.
Autoimmune diseases.
Use of neuroleptics/antiarrhythmic.
Nasal abnormalities such as nasal polyps.
Unconscious patients.
|
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood Pressure
Heart rate
Quality of Life
|
Baseline day 1
After 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Systolic blood pressure and Diastolic Blood pressure
Resting Heart rate
MINICHAL QoL: Mental and Somatic manifestations |
0 day 28 day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/06/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypertension
is the most common controllable disease affecting around 40% of the adult population
worldwide. It is an important
public health challenge in both economically developing and developed countries. A multidisciplinary approach, comprising clinical,
pharmacological treatment and non-pharmacological intervention is more effective
in optimal control of blood pressure. Many studies have been conducted to control blood pressure as non-pharmacological management. Like Aerobic training, breathing exercise, alternate nostril breathing, inspiratory muscle training etc.
Previous studies have reported that autonomic cardiovascular control
alterations with different breathing patterns implicating a ventilatory
influence on hemodynamics. So respiratory control exercises may be an
applicable treatment option for hypertension with a more favorable effect. But there is a lack of evidence which suggest
more effective treatment among of inspiratory muscle training and alternative
nostril yoga breathing on blood pressure and heart rate in essential
hypertension, hence there is a need to compare the effectiveness of inspiratory muscle training
versus alternative nostril yoga breathing on quality of life
questionnaire in essential
hypertension. |