| CTRI Number |
CTRI/2025/08/093232 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Pressure biofeedback effect in subjects with reflux disease to reduce acid reflux symptoms and improve health quality |
|
Scientific Title of Study
|
Added Effect of Pressure Biofeedback Guided Shakers and Diaphragmatic Strengthening Exercises In Subjects With Gastroesophageal Reflux Disease On Frequency and Quality Of Life A Randomized Controlled 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 |
Vandana M Chandaragi |
| Designation |
Post Graduate student |
| Affiliation |
KLE Universitys Institute of Physiotherapy |
| Address |
KLES Dr Prabhakar Kore Hospital and MRC Advanced
Physiotherapy Centre Orthopaedic Department Room number 18 Nehru nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
07892641910 |
| Fax |
|
| Email |
chandaragivandana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Professor |
| Affiliation |
KAHER |
| Address |
KLES Dr Prabhakar Kore Hospital and MRC Advanced
Physiotherapy Centre Orthopaedic Department Room number 18 Nehru nagar Belagavi Karnataka India 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeoo123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Professor |
| Affiliation |
KAHER |
| Address |
KLES Dr Prabhakar Kore Hospital and MRC Advanced
Physiotherapy Centre Orthopaedic Department Room number 18 Nehru nagar Belagavi Karnataka India 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeoo123@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr Prabhakar Kore Hospital and MRC Advanced
Physiotherapy Centre Orthopaedic Department Room number 18 Nehru nagar Belagavi Karnataka India 590010 |
|
|
Primary Sponsor
|
| Name |
Vandana M Chandaragi |
| Address |
KLES Dr Prabhakar Kore Hospital and MRC Advanced
Physiotherapy Centre Orthopaedic Department Room number 18 Nehru nagar Belagavi Karnataka India 590010 |
| 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 Vandana Chandaragi |
KLE Institute Of Physiotherapy ,Belagavi |
KLES Dr.Prabhakar
Kore Hospital and MRC
Advanced
Physiotherapy Centre
Orthopaedic
Department. Room
no 18 Nehru nagar
Belagavi 590010
KARNATAKA
Belgaum
KARNATAKA |
7892641910
chandaragivandana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KLEU institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pressure biofeedback guided shakers and diaphragmatic stregthening exercise |
The intervention will be given for 10 sessions over 2 weeks and 2 week follow-up |
| Comparator Agent |
shakers exercise and diaphragmatic breathing exercises
|
the intervention will be given for 10 sessions over 2 weeks and 2 week follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All genders with GERD in the 18-65 age group of years 1
Scores should be MOEW THEN 8 on FSSG and Gerd Q Scales
Referred by Gastroenterologist for GERD
Have signed informed consent and are willing to participate.
subjects who can comprehend commands.
|
|
| ExclusionCriteria |
| Details |
Past history of any pharyngeal surgery procedures
Cognitive impairments and psychological disorders
History of alcoholic neuropathy
Present or previous history of gastric cancer
Subjects who are currently on any medications or drugs(anticholinergics) which can induce GERD symptoms
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Frequency Scale for symptoms of GERD
2 The GERD Questionnaire
3 GERD –Health Related Quality of Life Questionnaire
|
baseline, after 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/08/2025 |
| Date of Study Completion (India) |
03/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/03/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Added Effect of Pressure Biofeedback Guided Shakers and Diaphragmatic Strengthening Exercises In Subjects With Gastroesophageal Reflux Disease On Frequency of and Quality Of Life A Randomized Controlled Trial AIMTo compare the effect of Pressure Biofeedback Guided Shakers Diaphragmatic Strengthening Exercises In Subjects With Gastroesophageal Reflux Disease. OBJECTIVE To determine and compare the added effect of Pressure Biofeedback Guided Shakers Diaphragmatic Strengthening Exercises in Subjects with Gastroesophageal Reflux Disease on Frequency of GERD using Frequency FSSG and Quality of Life using GERD Health Related Quality of Life Questionnaire • Null Hypothesis There will be no significant difference between Pressure Biofeedback Guided Shakers and Diaphragmatic strengthening Exercises in Subjects with Gastroesophageal Reflux Disease using Frequency scale for symptoms of GERD, The Gerd Q questionnaire and quality of life using GERD Health Related Quality of Life Questionnaire • Alternative Hypothesis There will be significant difference between Pressure Biofeedback Guided Shakers and Diaphragmatic strengthening Exercises in Subjects with Gastroesophageal Reflux Disease using Frequency scale for symptoms of GERD The Gerd Q questionnaire and quality of life using GERD Health Related Quality of Life Questionnaire PROCEDURE:Prior to commencing the study, ethical clearance will be obtained from the institutional ethical committee.The CTRI will be registered prospectively All aseptic precautions as per the ICMR guidelines will be followed. Participants will be briefed about the purpose of the study and they will be included based on the inclusion and exclusion criteria. A written informed consent will be taken from those consenting to participate in the study and a brief demographic data will be obtained from Participants prior to the assessment. Participants will be randomly divided into two group Group A participants will receive Pressure Biofeedback Guided Shaker’s Exercises Diaphragmatic strengthening exercises Group B participants will receive Shakers exercise Diaphragmatic breathing exercises Data collection sheet with brief demographic information and pre-assessment of outcome measures will be done to all the participants.Subjects will be again assessed for same outcome measures, post intervention. The data will be collected and analysed Subjects in Group A will be given Pressure Biofeedback Guided Shaker’s Exercises Diaphragmatic strengthening exercise for 2weeks and 2 week follow-up then a post-assessment of same outcome measures will be done at the end of 2 week of intervention Subjects in Group B will be given 2-week Shaker’s Exercises Diaphragmatic breathing exercise for 2weeks and 2week follow-up then a post-assessment of same outcome measures after 2weeks will be done |