跳至主要内容
临床试验/NCT06473454
NCT06473454招募中不适用

the Effect of Aerobic Exercise and Basic Body Awareness Therapy on Quality of Life and Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome: A Randomized Controlled Trial

Istanbul Saglik Bilimleri University2 个研究点 分布在 2 个国家目标入组 72 人开始时间: 2024年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
72
试验地点
2
主要终点
IBS Quality of Life Scale

研究概览

简要总结

The research will be planned on 72 individuals between the ages of 18-65 who were diagnosed with irritable bowel syndrome at Istanbul Medipol University Çamlıca SUAM Gastroenterology Polyclinic. Patients will be divided into 3 groups; High-intensity interval training and a disease-specific nutrition program for the first group, and a disease-specific nutrition program for the second group; Basic Body Awareness Therapy (BBAT) and a disease-specific nutrition program will be given, while the control group will be given only a disease-specific nutrition program. Evaluations will be made immediately before and after treatment. The first experimental group will be asked to walk with high-intensity interval training, which the investigators plan for 30 minutes, 4 days a week for 8 weeks. TBFT will be applied to the second experimental group every day of the week. The application will be done face to face one day a week, and the patient will be asked to do it himself on the other days, and the sessions will last approximately 30 minutes. In addition, all patients will be asked to follow the nutrition program determined by the dietician. Participants' sociodemographic information, IBS disease type and medications used will be recorded. In order to collect data for both the intervention groups and the control group immediately before and after the study; 6 Minute Walk Test (6MWT), posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities, International Physical Activity Questionnaire Short Form (IPAQ-SF), Diet Compliance Questionnaire Form, Bristol Stool Scale Form, Gastrointestinal Symptom Assessment Scale (GSDS). ), Pittsburgh Sleep Quality Index (PSQI), IBS Quality of Life Scale (IBS-QOL), Morningness-Eveningness Questionnaire (SAA), Psychological Well-Being Scale (PIOS) and Body Awareness Questionnaire (VFA) will be used.

详细描述

Irritable bowel syndrome (IBS); It is one of the most frequently diagnosed gastrointestinal diseases, defined by the presence of altered bowel habits, abdominal pain, and discomfort in the absence of another causative disease. The research will be planned on 72 individuals between the ages of 18-65 who were diagnosed with IBS at Istanbul Medipol University Çamlıca SUAM Gastroenterology Polyclinic. Patients will be divided into 3 groups; High-intensity interval training and a disease-specific nutrition program for the first group, and a disease-specific nutrition program for the second group; Basic Body Awareness Therapy (BBAT) and a disease-specific nutrition program will be given, while the control group will be given only a disease-specific nutrition program. Evaluations will be made immediately before and after treatment. The first experimental group will be asked to walk with high-intensity interval training, which the investigators plan for 30 minutes, 4 days a week for 8 weeks. TBFT will be applied to the second experimental group every day of the week. The application will be done face to face one day a week, and the patient will be asked to do it himself on the other days, and the sessions will last approximately 30 minutes. In addition, all patients will be asked to follow the nutrition program determined by the dietician. Participants' sociodemographic information, IBS disease type and medications used will be recorded. In order to collect data for both the intervention groups and the control group immediately before and after the study; 6 Minute Walk Test (6MWT), posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities, International Physical Activity Questionnaire Short Form (IPAQ-SF), Diet Compliance Questionnaire Form, Bristol Stool Scale Form, Gastrointestinal Symptom Assessment Scale (GSDS). ), Pittsburgh Sleep Quality Index (PSQI), IBS Quality of Life Scale (IBS-QOL), Morningness-Eveningness Questionnaire (SAA), Psychological Well-Being Scale (PIOS) and Body Awareness Questionnaire (VFA) will be used. Physiotherapy and rehabilitation applications of aerobic exercise and TBFT have been rarely studied in the literature on patients with IBS; this will be the first and original study, as there are no studies examining the effects of a disease-specific nutrition program on gastrointestinal symptoms, quality of life, sleep quality and well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Being between the ages of 18-65
  • Compliance with Rome IV criteria
  • Declaring that you wish to participate in the study with written consent

排除标准

  • Voluntary refusal to participate in the study
  • Having a psychiatric illness
  • Not having any orthopedic, neurological or cardiopulmonary disease that would constitute a contraindication for the protocols to be applied.
  • Do not pose any risk of injury while working in line with posture analysis.
  • In case the limitations in muscle shortness tests prevent the study
  • Using laxatives regularly
  • Being diagnosed with diabetes or a metabolic disease that will affect the gastrointestinal system
  • No history of Inflammatory Bowel Disease (IBD), colon cancer or colon resection
  • Using antibiotics and probiotics in the last 3 months
  • Using anticholinergic, opiate or morphine-type drugs that will affect intestinal motility
  • Getting diagnosed with celiac disease

结局指标

主要结局

IBS Quality of Life Scale

时间窗: pre-intervention and immediately after the intervention

It was specifically developed to evaluate the quality of life of patients diagnosed with IBS. The scale is Likert type, consisting of 34 items, 8 subgroups and 5 options (1: not at all, 2: little, 3: moderate, 4: a lot, 5: a lot). According to the options, the first statement is given 5 points and the fifth statement is given 1 point. Score calculation is made differently according to 8 subgroups in the determined direction. With this scoring system, the lowest score that can be obtained from the scale is 34 and the highest score is 170. It is thought that as the total score increases, the quality of life due to the disease also increases.

Gastrointestinal Symptom Assessment Scale (GSDS)

时间窗: pre-intervention and immediately after the intervention

It was developed to evaluate the symptoms frequently seen in gastrointestinal system diseases. The patient is asked how he/she feels about the gastrointestinal problems he/she has encountered in the last week. On scale; abdominal pain (items 1, 4, 5), reflux (item 2, 3), indigestion (item 6, 7, 8, 9), diarrhea (item 11, 12, 14). There are five sub-dimensions consisting of items) and constipation (10th, 13th, 15th items) and consists of 15 items in total. It is in Likert type; It consists of 7 options, starting from "no discomfort" to "very severe discomfort" and the total score varies between 15 and 105. An increase in the total score indicates that the symptoms are getting worse.

次要结局

  • Body Awareness Questionnaire(pre-intervention and immediately after the intervention)
  • Bristol Stool Scale Form(pre-intervention and immediately after the intervention)
  • 6 Minute Walk Test (6MWT)(pre-intervention and immediately after the intervention)
  • Psychological Well-Being Scale(pre-intervention and immediately after the intervention)
  • International Physical Activity Questionnaire Short Form (IPAQ-SF)(pre-intervention and immediately after the intervention)
  • Pittsburgh Sleep Quality Index (PSQI)(pre-intervention and immediately after the intervention)
  • posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities(pre-intervention and immediately after the intervention)
  • Morningness-Eveningness Questionnaire(pre-intervention and immediately after the intervention)

研究者

发起方
Istanbul Saglik Bilimleri University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beyza Baris Erdogmus

physiotherapist

Istanbul Saglik Bilimleri University

研究点 (2)

Loading locations...

相似试验