Effects of Indoor Activity on the Integrity and Function of the Intestinal Barrier of Patients With Fibromyalgia and Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Fibromyalgia symptom assesment
研究概览
简要总结
The project focuses on "somatic functional syndrome", a category of disorders characterized by subjective symptoms, suffering and disability without evident organic or functional alterations. Syndromes such as Fibromyalgia, Irritable Bowel, Chronic Fatigue and Restless Legs fall into this category. Patients seek diagnoses and treatments, often consulting multiple doctors. The proposed alternative approach involves physical activity as the cornerstone of therapy, with a focus on fibromyalgia.
Fibromyalgia manifests itself with musculoskeletal pain, chronic fatigue, sleep disturbances and other symptoms. The text highlights a correlation between fibromyalgia and gastrointestinal disorders, in particular Irritable Bowel. Both syndromes share pathophysiological mechanisms, including alteration of intestinal permeability and psychosocial factors.
An important note is the possible compromise of the integrity of the intestinal wall, with consequences on general health. Inflammation, dysbiosis, and altered intestinal permeability contribute to a vicious cycle that can lead to cardiovascular, neurodegenerative, and inflammatory diseases.
Regular physical activity is a possible improvement for fibromyalgia symptoms, with scientific studies demonstrating its effectiveness. A sedentary lifestyle is linked to gastrointestinal problems, and physical exercise can promote gastrointestinal motility and counteract disorders such as gastric reflux and irritable bowel syndrome.
The research aims to focus on the effects of physical activity on gastrointestinal and extra-gastrointestinal symptoms in patients with fibromyalgia and irritable bowel disease. The effects on intestinal integrity, dysbiosis and markers of inflammation are also examined. The research also aims to evaluate the psychological aspects of these syndromes.
详细描述
Patient Recruitment: the study protocol has been designed as a prospective, single-center, active-agent-controlled comparison in parallel groups of adult outpatients (18-65 years) affected by:
- fibromyalgia (FM), from the "Rheumatology" Clinic of the National Institute of Gastroenterology "S de Bellis" Castellana G;
- irritable bowel syndrome (IBS), from the "Celiac Disease and Functional Disorders" Clinic of the National Institute of Gastroenterology "S de Bellis" Castellana G;
- both comorbidities (FM+IBS) from the above-cited clinics. The patients will also be recruited among the fibromyalgia patients registered with the "Smile Association" of Castellana G. (BA).
Information regarding the participant's health status will be gathered through a comprehensive visit, encompassing an interview covering lifestyle, medical history, and a physical examination. Additionally, metabolic parameters, including blood sugar, HbA1c, lipid profile, and body weight, must fall within the normal range of values. Before providing written consent, all participants will receive verbal and written details of the study. The recruitment and evaluation of patients will be structured into the following phases:
V1. (Day -14): Patients will be briefed on the study and consent to it. A clinical anamnestic form will be filled out to account for the influence of current medications. For the next 14 days, participants will keep a daily symptom diary, noting stool characteristics with the Bristol scale and evaluating intestinal habits.
V2. (Day 0): Patients will return for blood sampling and the collection of essential biological samples (urine, feces) required for laboratory evaluations as specified by the study. Additionally, they will fill out questionnaires on gastrointestinal (GI) and fibromyalgia (FM) symptoms. During this visit, psychological, quality of life (QoL), physical activity assessments and anthropometric and bioimpedance measurements will be conducted. Field tests to gauge physical fitness will be performed. Patients will receive instructions, supported by specialized personnel, to follow a specific indoor physical activity regimen. Every four weeks, the same field tests from V2 will be conducted to monitor the effectiveness of the work protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •Satisfaction of the ACR diagnostic criteria for the diagnosis of FM,
- •A total Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) score of ≥ 125 (moderate to severe IBS symptoms) for the satisfaction of the Rome III-IV criteria in patients with IBS.
排除标准
- •Serious cardiac, hepatic, neurological, psychiatric, or gastrointestinal diseases other than IBS (e.g., inflammatory bowel disease, diverticular disease/diverticulitis) that could explain the current symptoms.
- •Specific therapy for symptoms due to pathologies (educational programs, alternative medicine, psychotherapy). In the case of subjects who were previously undergoing treatment, they may participate in the study provided they suspend the ongoing therapy until the symptoms reappear.
- •The use of drugs to treat FM and IBS.
研究组 & 干预措施
AF-FM
Patients with Fibromyalgia
干预措施: Exercise Program (Behavioral)
AF-IBS
Patients with irritable bowel syndrome
干预措施: Exercise Program (Behavioral)
AF-FM-IBS
Patients with fibromyalgia and irritable bowel syndrome
干预措施: Exercise Program (Behavioral)
结局指标
主要结局
Fibromyalgia symptom assesment
时间窗: At baseline and day 120
To evaluate the effectiveness of an exercise intervention on IBS symptoms as measured by a change in the Fibromyalgia Impact Questionnaire, modified version (FIQ-R) scores from baseline. The FIQ serves as a tool for assessing and evaluating the condition of patients with fibromyalgia (FM) and tracking their progress and outcomes. Specifically designed to gauge the aspects of health status most impacted by FM, the FIQ comprises ten items. The initial item consists of 11 questions about physical functioning, each rated on a 4-point Likert-type scale. The subsequent items (2 and 3) prompt patients to indicate the number of days they felt well and the days they were unable to engage in work or housework due to FM symptoms. Items 4 through 10 feature horizontal linear scales with ten increments, allowing patients to rate work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression.
IBS symptoms assessment
时间窗: At baseline and day 120
To evaluate the effectiveness of an exercise intervention on IBS symptoms as measured by a change in the IBS-Symptom Severity Scale (IBS-SSS) questionnaire score from baseline. The IBS-SSS is a validated questionnaire for gastrointestinal symptoms and provides a global measure of symptom severity by assessing five items ("severity of abdominal pain", "frequency of abdominal pain", "severity of abdominal distension", "dissatisfaction with bowel habits", "impact of symptoms on quality of life") on a visual analog scale. The values of the five items are added together to give a total score between 0 and 500. Cases are then classified as 'mild' (75 to 175), 'moderate' (175 to 300) and 'severe' (\>300).
次要结局
- Gastroduodenal permeability(At baseline and day 120)
- Psychological Assessment:(At baseline and day 120)
- Intestinal microbiota analysis(At baseline and day 120)
- Evaluation of Intestinal dysbiosis(At baseline and day 120)
- Evaluation of Barrier Peptide Integrity(At baseline and day 120)
研究者
Francesco Russo
MD
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis