NCT05374967进行中（未招募）不适用
The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients With Inflammatory Bowel Disease
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年5月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Fatigue at six months
研究概览
简要总结
Chronic fatigue is highly prevalent in patients with conditions characterized by chronic inflammation of the gastrointestinal tract, also known as Inflammatory Bowel Disease (IBD). Chronic fatigue has multiple causes, including alterations in immune system or gut microbiota, psychological factors, and sleeping problems. Unsurprisingly, fatigue has been associated with decreased quality of life, general well-being, and work productivity. Very few patients experience resolution in fatigue, emphasizing the need for new therapies. It has been shown that lifestyle interventions can improve most of fatigue-driving factors. Hence, the investigators hypothesize that a multimodal lifestyle intervention focusing on nutrition, sleep, stress, and exercise will improve chronic fatigue in patients with IBD. During this multicenter, controlled trial, the investigators will compare a multimodal lifestyle intervention to a standard therapy (i.e., an informational brochure on how to cope with chronic fatigue).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old)
- •Established IBD diagnosis (Crohn's disease, Ulcerative colitis, or IBD-unclassified)
- •Biochemical remission (fecal calprotectin ≤150 mcg/g)
- •Clinically significant fatigue (visual analog score 4-8 out of 10)
- •Willing and able to attend digital group sessions as a part of the intervention
排除标准
- •Documented comorbidities such as severe cardiac failure (classified as NYHA 3-4), chronic kidney disease, myelodysplastic syndrome, Chronic Obstructive Pulmonary Disease (COPD), inherited metabolic diseases (e.g., phenylketonuria, mitochondrial or uric acid cycle pathologies), diabetes type 1
- •Documented history of malignancy within the last three years before inclusion except for dermatological cancers such as basal cell carcinoma or squamous cell carcinoma
- •Documented history of psychiatric diseases, eating disorders, or addiction. Exception: patients with a history of depression and/or under treatment with antidepressants; however, at inclusion the patients must have a Hospital Anxiety Depression Scale (HADS) score <11 for the depression subscale
- •Documented familial hypercholesterolemia
- •Diabetes type 2 treated with insulin or other medications such as sulfonylureas, glinides, alpha-glucosidase inhibitors, etc. The only exception is biguanides-metformin
- •BMI <18.5 or >35 kg/m2
- •Clinically significant anemia (Hb <7.0 mmol/l in females, Hb <8.0 mmol/l in males) with the exception of marginal normocytic or macrocytic anemia (MCV >100 fL and Hb >7.0 mmol/L for females and Hb >8.0 mmol/L for males) as a result of IBD-therapy related myelosuppression
- •Vitamin B12 or folic acid deficiency
- •Iron deficiency (defined as ferritin <30 μg/l)
- •Vitamin D deficiency (<30 nmol/l)
- •History of prior bariatric surgery or upper gastrointestinal surgery such as Roux-Y reconstruction or (partial) gastrectomy due to benign or malignant pathologies
- •Pregnancy or active breastfeeding
- •Unwillingness to follow the lifestyle program, i.e. people that do not want to eat fish, vegans
- •Any change in IBD-related systemic medication within the last three months of intervention. Changes in medication dose are allowed up to 1 month before the start of the intervention. Exception: changing the route of administration (e.g., switching from intravenous infliximab to subcutaneous infliximab) or change in therapy due to side effects such as an allergic reaction or cutaneous conditions.
- •Recent major surgery, e.g. laparotomy in the last four weeks
- •Extended hospitalization (a >2-week admission) within four weeks before inclusion
- •Unable to speak and understand Dutch language
- •Participation in another study with lifestyle intervention or active consultation with a lifestyle coach on patient's initiative
- •Previous participation in the IBD-tailored program by Voeding Leeft
结局指标
主要结局
Fatigue at six months
时间窗: Six months after starting the intervention
Percentage of patients who experience a reduction in fatigue at six months compared between the intervention and the control group. The reduction in fatigue is defined as any increase in The Functional Assessment of Chronic Illness Therapy - Fatigue ((FACIT-F) score (0-160 with lower scores indicating worse fatigue) at six months compared with the baseline.
次要结局
- Mean Clinically Important Difference in quality of life (EQ-5D VAS).(at three months, at six months, and at 12 months after the start of the intervention.)
- Mean change in fatigue (FACIT-F)(at three months, at 12 months after the start of the intervention.)
- Mean change in fatigue (fatigue VAS)(at three months, at 12 months after the start of the intervention.)
- Mean change in quality of life (EQ-5D VAS)(at three months, at six months, and at 12 months after the start of the intervention.)
- Mean change in activity impairment(at six months and at 12 months after the start of the intervention.)
- Mean change in sleep quality(at three months, at six months, and at 12 months after the start of the intervention.)
- Correlation between locus of control and lifestyle changes(baseline, at six months and at 12 months after the start of the intervention.)
- Mean change in quality of life (SIBDQ)(at three months, at six months, and at 12 months after the start of the intervention.)
- Mean Clinically Important Difference in activity impairment (WPAI:IBD)(at six months and at 12 months after the start of the intervention.)
- Mean change in coping with the illness(at three months, at six months, and at 12 months after the start of the intervention.)
- Mean change in medical consumption(at three months, at six months, and at 12 months after the start of the intervention.)
- Mean Clinically Important Difference in fatigue (FACIT-F)(at three months, at six months, and at 12 months after the start of the intervention.)
- Mean Clinically Important Difference in quality of life (SIBDQ)(at three months, at six months, and at 12 months after the start of the intervention.)
- Mean change in dietary quality measured by Adjusted Mediterranean Diet Serving Score(at three months, at six months, and at 12 months after the start of the intervention.)
- Correlation between fatigue and lifestyle (i.e., nutrition, exercise, sleep, stress)(baseline, at six months and at 12 months after the start of the intervention.)
- Cost-effectiveness of the intervention(at six months and at 12 months after the start of the intervention.)
- Mean change in physical exercise(at three months, at six months, and at 12 months after the start of the intervention.)
- Mean change in perceived stress(at three months, at six months, and at 12 months after the start of the intervention.)
研究者
Pieter Maljaars
Principal Investigator
Leiden University Medical Center
研究点 (2)
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