跳至主要内容
临床试验/CTRI/2025/08/093232
CTRI/2025/08/093232已完成不适用

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

Vandana M Chandaragi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月29日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
1 Frequency Scale for symptoms of GERD

研究概览

简要总结

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 HypothesisThere 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 HypothesisThere 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

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

1 Frequency Scale for symptoms of GERD

时间窗: baseline, after 2 weeks

2 The GERD Questionnaire

时间窗: baseline, after 2 weeks

3 GERD –Health Related Quality of Life Questionnaire

时间窗: baseline, after 2 weeks

次要结局

未报告次要终点

研究者

发起方
Vandana M Chandaragi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vandana M Chandaragi

KLE Universitys Institute of Physiotherapy

研究点 (1)

Loading locations...

相似试验