NL-OMON54056招募中不适用
The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients with Inflammatory Bowel Disease - Multi-IBD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •o Adults (>=18 years old);
- •o Established IBD diagnosis (Crohn*s disease, Ulcerative colitis, or
- •IBD-unclassified);
- •o Biochemical remission (fecal calprotectin <=150 mcg/g);
- •o Clinically significant fatigue (VAS 4-8 out of 10);
- •o Willing and able to attend digital group sessions as a part of the
- •intervention.
排除标准
- •o 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;
- •o Documented history of malignancy within the last three years before inclusion
- •except for dermatological cancers such as basal cell carcinoma or squamous cell
- •o 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 these patients must have a Hospital
- •Anxiety Depression Scale (HADS) score <11 for the depression subscale;
- •o Documented familial hypercholesterolemia;
- •o Diabetes type 2 treated with insulin or other medications such as
- •sulfonylureas, glinides, alpha-glucosidase inhibitors, etc. The only exception
- •is biguanides*metformin.;
- •o BMI <18.5 or >35 kg/m2;
- •o 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;
- •o Vitamin B12 deficiency (defined as a concentration below the lower reference
- •range expressed in units that are used by the laboratory where the test has
- •been performed);
- •o Folic acid deficiency (defined as a concentration below the lower reference
- •range expressed in units that are used by the laboratory where the test has
- •been performed);
- •o Iron deficiency (defined as ferritin <30 µg/l);
- •o Vitamin D deficiency (<30 nmol/l);
- •o History of prior bariatric surgery or upper gastrointestinal surgery such as
- •Roux-Y reconstruction or (partial) gastrectomy due to benign or malignant
- •pathologies;
- •o Pregnancy or active breastfeeding;
- •o Unwillingness to follow the lifestyle program, i.e. people that do not want
- •to eat fish, vegans;
- •o Any change in systemic IBD-related medication in the last three months from
- •the start of the intervention. Changes in medication dose are allowed up to one
- •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.
- •o Recent major surgery, e.g. laparotomy in the last four weeks;
- •o Recent >2-week long hospitalization (in the last four weeks);
- •o Unable to speak and understand Dutch language;
- •o Participation in another study with lifestyle intervention or active
- •consultation with a lifestyle coach on patient*s initiative;
- •o Previous participation in the IBD-tailored program by Voeding Leeft.
研究者
相似试验
已完成
不适用
The effects of a combined lifestyle intervention in overweight patients with hip osteoarthritis: a pilot studyarthritis10023213osteoarthritisNL-OMON31407niversitair Medisch Centrum Groningen25
招募中
不适用
The effects of a combined lifestyle intervention in overweight patients with hip osteoarthritis: a pilot studyObese, overweight, osteoarthritis of the hip, exercise, weight loss, lifestyle intervention, combination therapy, pain, functional abilities.NL-OMON26093Department of Orthopaedic Surgery University Medical Center Groningen25
尚未招募
Unknown
healthy lifestyle practices to manage risk for of coronary artery disease among perimenopausal womeCTRI/2023/12/060441o
进行中（未招募）
Unknown
Effects of the use of Protein Supplements and Physical Exercise in elderlyProtein-Energy MalnutritionC10.597.613.612.500RBR-5ztk3mwniversidade Federal da Bahia
已完成
不适用
A lifestyle health intervention in airline pilots during a global pandemicPhysical inactivityInadequate sleepInsufficient fruit and vegetable intakeDiet and Nutrition - ObesityPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitationPublic Health - Health promotion/educationCardiovascular - HypertensionHypertensionObesityACTRN12621001105831Daniel Wilson72