| CTRI Number |
CTRI/2026/02/103373 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of suboccipital release versus diaphragmatic release combined with relaxation technique on blood pressure sleep quality and stress level in pre hypertention |
|
Scientific Title of Study
|
Effect of suboccipital release versus diaphragmatic release technique combined with relaxation technique on blood pressure stress level and sleep quality in pre hypertention A randomized clinicl trial |
| 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 Aarti Welling |
| Designation |
Associate Professor, Department of Orthopaedic Physiotherapy |
| Affiliation |
KLE Institute of physiotherapy Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
09448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti Welling |
| Designation |
Associate Professor, Department of Orthopaedic Physiotherapy |
| Affiliation |
KLE Institute of physiotherapy Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
09448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarti Welling |
| Designation |
Associate Professor, Department of Orthopaedic Physiotherapy |
| Affiliation |
KLE Institute of physiotherapy Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
09448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Aarti welling |
| Address |
KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka-590010 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aarti welling |
KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka-590010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aarti Welling |
KLES Dr. Prabhakar Kore Hospital orthopeadic department room Nehru Nagar, Belagavi, 590010 |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA |
09448814569
aartiwell88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committe, KLEU Institute of Physiotherapy, Belagavi |
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 |
diaphragmatic release with conventional physiotherapy |
Participants will recive diaphragmatic release , combined with conventional physiotherapy. Conventional physiotherapy relaxation technique. All interventions will be administered under physiotherapist supervision. 3 session will be administered for 4 weeks by a trained physiotherapist. |
| Intervention |
Suboccipital release with conventional physiotherapy |
Participants will receive suboccipital release , combined with conventional physiotherapy. Conventional physiotherapy relaxation technique. All interventions will be administered under physiotherapist supervision. 3 session will be administered for 4 weeks by a trained physiotherapist. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group – young adults (18 - 40 years)
2. All genders
3. Blood Pressure ranging between 120 - 140 (systolic)/80 -90 (Diastolic) (prehypertension)
4. Individuals willing to participate in this study |
|
| ExclusionCriteria |
| Details |
1. Diagnosed case of cardio-respiratory, musculoskeletal or
neurological disorders.
2. Diagnosed case of skin infections or disorders
3. Diagnosed case of sensory disorders and systemic conditions
4. Individuals with ongoing antihypertensive medications.
5. Pregnant women
6. Recent trauma or surgery.
7. Contraindicated to manual therapy (osteoporosis, vascular issues, hypertension) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure: Measured by a Mercury Sphygmomanometer |
Blood pressure will be assessed pre-intervention and post intervention
over four weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Sleep quality assesed by Pittsburgh Sleep Quality Index (PSQI)
2. Stress assesed by PSS Scale Perceived stress scale |
1. sleep quality will be assessed pre-intervention and post intervention
over four weeks.
2.stress level will be assessed pre-intervention and post intervention
over four weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/02/2026 |
| 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
|
Prehypertension is a highly prevalent condition, affecting nearly 31–41% of adults, particularly younger populations, and is commonly associated with obesity, dyslipidaemia, stress, and poor sleep quality, with nearly 19% progressing to hypertension within four years. It is a major risk factor for cardiovascular and cerebrovascular diseases due to autonomic imbalance, vascular remodelling, and increased cardiac workload. Exercise and relaxation-based interventions have shown promise in blood pressure control, with Jacobson relaxation exercises, diaphragmatic release technique (DRT), and suboccipital release technique (SRT) demonstrating beneficial effects on autonomic regulation, stress reduction, and sleep quality through vagal modulation and central autonomic pathways. However, comparative evidence between DRT and SRT in prehypertensive individuals remains limited. Therefore, this randomized clinical trial aims to compare the effectiveness of diaphragmatic release and suboccipital release techniques combined with relaxation exercises in reducing blood pressure, perceived stress, and improving sleep quality among prehypertensive adults aged 18–40 years. Thirty participants will be randomly allocated into two groups: Group A receiving diaphragmatic release with relaxation techniques and Group B receiving suboccipital release with relaxation techniques, administered for 20–30 minutes, three sessions per week over four weeks. Outcome measures include blood pressure assessed using a mercury sphygmomanometer, sleep quality measured by the Pittsburgh Sleep Quality Index, and stress levels evaluated using the Perceived Stress Scale. Pre- and post-intervention assessments will be conducted, and the collected data will be statistically analyzed to determine the more effective intervention for improving cardiovascular health, stress, and sleep outcomes in prehypertensive individuals |