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
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
Vandana M Chandaragi
KLE Universitys Institute of Physiotherapy
