| CTRI Number |
CTRI/2025/02/081103 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The Effect of Breathing Exercises on Lowering Blood Pressure in Young prehypertensive Adults |
|
Scientific Title of Study
|
Effect of Inspiratory Muscle Training on Blood Pressure in Young Prehypertensive Adults in Anand Vicinity. |
| 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 Ashish Gupta |
| Designation |
Professor |
| Affiliation |
K M Patel institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K.M. Patel institute of physiotherapy, room no-152, karamsad, Anand gujarat, 388325, India
Anand
GUJARAT
388325
India |
| Phone |
9925048223 |
| Fax |
|
| Email |
ashishvg@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Gupta |
| Designation |
Professor |
| Affiliation |
K M Patel institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K.M. Patel institute of physiotherapy, room no-152, karamsad, Anand gujarat, 388325, India
Anand
GUJARAT
388325
India |
| Phone |
9925048223 |
| Fax |
|
| Email |
ashishvg@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Solanki |
| Designation |
MPT Student |
| Affiliation |
K M Patel institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K.M. Patel institute of physiotherapy, room no-152, karamsad, Anand gujarat, 388325, India
Anand
GUJARAT
388325
India |
| Phone |
7201959009 |
| Fax |
|
| Email |
aditisolanki1242@gmail.com |
|
|
Source of Monetary or Material Support
|
| The young adult Participants from different colleges and hostels of Anand Vicinity, Gujarat, India-388001 will be assessed for the prehypertension and recruited for the study |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Solanki Self Funded |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325 |
| 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 Aditi Solanki |
K M Patel Institute of Physiotherapy |
K M Patel Institute of Physiotherapy, Shree Krishna Hospital, Room no 152, Karamsad, Anand, Gujarat
Anand
GUJARAT |
7201959009
aditisolanki1242@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University, Karamsad, Anand, Gujarat-388725 [DHR Reg. No. EC/NEW/INST/2021/592][OHRP Reg. No. IRB00014178] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PREHYPERTENSION. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable. |
Not Applicable. |
| Intervention |
Physiotherapy Exercise Program. |
The Inspiratory Muscle Training (IMT) program using a device designed to strengthen respiratory muscles. Participants will use a respiratory muscle training device as prescribed, performing specific breathing exercises aimed at strengthening the inspiratory muscles for 4 weeks.
In addition to IMT, they will also receive care and precaution pamphlets to help control prehypertension. All IMT sessions will be supervised by researcher to ensure correct technique, provide feedback, and monitor progress.
Duration: 4 weeks
Frequency: 5 days per week
Device: Inspiratory muscle training device (Threshold device) with adjustable resistance settings.
Intensity: 40% of maximal inspiratory pressure (progressively increased weekly)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who are willing to participate
2. Age group – 18-45
3. Pre hypertensive individual (i.e. systolic (120-139) and diastolic (80-89)diagnosed.
4. No history of cardiovascular disease, respiratory disease, or severe musculoskeletal disorders.
|
|
| ExclusionCriteria |
| Details |
1. The presence of any comorbidity (such as diabetes, chronic heart failure)
2. For individuals checking their blood pressure for the first time and finding it above the prehypertensive range, that indicates the stage of hypertension.
3. History of cardiovascular disease and severe respiratory conditions.
4. Use of medications affecting blood pressure or respiratory function.
5. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure via sphygmomanometer |
Pre and Post of the intervention and during the follow-up session (i.e. 2 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 6 Min Walk Test |
Pre and Post of the intervention and during the follow-up session (i.e. 2 weeks) |
| Measurement of maximal inspiratory pressure |
Pre and Post of the Intervention and during the follow-up session(i.e. 2 weeks) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/02/2025 |
| 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)
|
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
|
Introduction: According to the Seventh Report of the Joint National Committee (JNC-7), prehypertension is defined as a systolic blood pressure (BP) of 120-139 mmHg or a diastolic BP of 80–89 mmHg. Individuals with prehypertension are at risk of developing hypertension, it has been suggested that early diagnosis and effective management strategies are essential. A study published in the International Journal of Public Health, which analyzed data from the National Family Health Survey (NFHS-5), found that prehypertension affected 33.7% of the population in India, with varying prevalence across districts among adults aged 18–54 years. Respiratory interventions have been proposed as a method of lowering blood pressure. Inspiratory muscle training (IMT) is a respiratory training technique in which patients breathe against a load set by their maximum static inspiratory pressure. This approach can improve tolerance and efficiency while reducing the blood pressure. Need Of The Study: Many studies indicate that Inspiratory muscle training is effective for patients with hypertension; however to the best of my knowledge, no studies have been conducted on the effect of inspiratory muscle training in prehypertensive young adults. Therefore, this study aims to evaluate the effect of inspiratory muscle training on prehypertensive young adults. Methodology: First goal is to identify young adults with prehypertension. A Minimum of 184 or more participants will be scrutinized for prehypertension from various areas within the Anand vicinity including hostels, to recruit participants for the study until the target sample size is achieved. From the recruited participants, 50 individuals with prehypertension will be selected to participate in the training period of the study.
To begin the recruitment process, the investigator will first check participants’ blood pressure (BP) to determine if they fall within the prehypertensive range. The BP assessment will be performed in the following steps: § Initial Blood Pressure Measurement: - BP will be measured using a sphygmomanometer and stethoscope at the brachial artery, in accordance with the American Heart Association guidelines (2020).
- Participants will be seated quietly with their back and arms supported for 5 minutes before measurement.
- Three BP measurements will be taken, with a 1-minute rest between each reading. The average of the last two measurements will be calculated. [8]
§ Eligibility Assessment: o Those with BP readings in the prehypertension range will be informed about the study and invited to take part in the research. However, before being enrolled, they must consult a physician to confirm their prehypertension status. - The physician will assess their BP readings and review their medical history to ensure that they fall within the prehypertensive range and meet the study’s inclusion criteria.
- Once the physician confirms the diagnosis of prehypertension, participants will be invited to sign the informed consent form and enroll in the study.
After enrolling the eligible participants, we will evaluate the effect of inspiratory muscle training on their prehypertension status. Those included in the study will undergo inspiratory muscle training for a duration of 4 weeks. The Inspiratory Muscle Training (IMT) program using a device designed to strengthen respiratory muscles. Participants will use a respiratory muscle training device as prescribed, performing specific breathing exercises aimed at strengthening the inspiratory muscles for 4 weeks. In addition to IMT, they will also receive care and precaution pamphlets to help control prehypertension. All IMT sessions will be supervised by researcher to ensure correct technique, provide feedback, and monitor progress. Duration: 4 weeks Frequency: 5 days per week Device: Inspiratory muscle training device (Threshold device) with adjustable resistance settings. Intensity: 40% of maximal inspiratory pressure (progressively increased weekly) Maximum inspiratory pressure (PIMAX) was assessed before each supervised training session, and the training device will be set to the appropriate resistance. Follow-up Assessments: At 2 weeks, repeat measurements of blood pressure and respiratory muscle strength.
Outcome : Primary Outcome: 1. Blood pressure will be determined via sphygmomanometer Secondary Outcome: 1. 6 Minute Walk Test
1. 2. Change in respiratory muscle strength (measured by maximal inspiratory pressure)
|