Comparison of Two Exercise Interventions and Dietary Advice in Patients With Fibromyalgia and Irritable Bowel Syndrome: A Randomized Controlled Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fibromyalgia symptom assesment
研究概览
简要总结
Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function.
The American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life.
Gastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms.
FM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation.
Exercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.
详细描述
Patient Recruitment: The study is designed as a randomized crossover trial. Patients will be recruited from the "Rheumatology," "Pain Therapy," and "Celiac Disease and Functional Disorders" adult (30-65 years) outpatient clinics at the IRCCS "S. de Bellis" in Castellana Grotte (BA). Recruitment will take place following the confirmation of a diagnosis of irritable bowel syndrome (IBS) concomitant with fibromyalgia (FM).
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:
V0. The patients will receive information about the study, sign an informed consent form, and complete a clinical history form. They will also maintain a daily symptom diary for 14 days. Furthermore, after confirming the inclusion criteria, participants will receive an accelerometer for 7 days to monitor their physical activity levels and sleep quality.
V1. Subjects will undergo blood sampling, urine, and stool sample collection, completion of questionnaires on gastrointestinal (GI) symptoms, fibromyalgia (FM), psychology, quality of life (QoL), and physical activity, as well as anthropometric measurements and bioimpedance analysis. Before the physical exercise intervention, field tests for physical fitness will be conducted, including handgrip strength tests, walking tests, and flexibility assessments. After obtaining certification of physical fitness for non-competitive sports activities, patients will be instructed to participate in a specific exercise program under the supervision of exercise specialists.
V2. Patients will repeat the GI, FM, psychology, QoL, and physical activity questionnaires. They will undergo the same functional tests and report adverse events. Blood and biological samples will be collected, and accelerometers will be worn for 7 days to assess changes in physical activity and sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
first treatment assignment is randomized
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Irritable Bowel Syndrome (IBS) concomitant with Fibromyalgia (FM).Meeting the American College of Rheumatology (ACR) diagnostic criteria for FM and meeting the Rome III/IV diagnostic criteria for IBS.
- •Total score on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) ≥ 125 (indicating moderate to severe IBS symptoms).
- •Men and women aged between 30 and 65 years.
- •Body Mass Index (BMI) between 18.5 and 29.9.
排除标准
- •Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases.
- •Individuals unable to discontinue symptom management therapies and medications for FM/IBS.
研究组 & 干预措施
FM+IBS Group 1
Patients with Fibromyalgia and IBS
干预措施: Combined Exercise Program + A specific nutritional plan for individuals with IBS (Behavioral)
FM+IBS Group 1
Patients with Fibromyalgia and IBS
干预措施: Aerobic Exercise + A specific nutritional plan for individuals with IBS (Behavioral)
FM + IBS Group 2
Patients with Fibromyalgia and IBS
干预措施: Combined Exercise Program + A specific nutritional plan for individuals with IBS (Behavioral)
FM + IBS Group 2
Patients with Fibromyalgia and IBS
干预措施: Aerobic Exercise + A specific nutritional plan for individuals with IBS (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
- Physical Fitness assessment(Al Baseline and day 120)
- Psychological Assessment:(At baseline and day 120)
- Evaluation of Barrier Peptide Integrity(At baseline and day 120)
- Intestinal microbiota analysis(At baseline and day 120)
- Evaluation of Intestinal dysbiosis(At baseline and day 120)
研究者
Antonella Bianco
Principal Investigator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis