OPTIMIZE-UC: Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Attrition
研究概览
简要总结
This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in Ulcerative Colitis (UC) patients with active disease as well as in patients in remission. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes.
详细描述
Rationale: Despite considerable advances in the knowledge of UC, and a variation of treatment options, UC still impacts patients' ability to lead a normal life. Clearly, there is an unmet need to improve treatment outcomes. Prehabilitation programs in surgery have shown that the amount of complications is closely related to preoperative physical fitness, nutritional status and psychological well-being. IBD patients often search for self-management strategies to manage their symptoms, however, research focussing on a multimodal intervention approach in parallel to starting new IBD treatment is lacking. Given the potential benefits of intervention programs, limitations of current treatments in terms of improving quality of life and patients' desire for self-management options, we believe that exploring the results of a multimodal intervention program in patients with UC is of high relevance.
Objective/study design: This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in UC patients. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes.
Study population: Patients ≥ 18 years old, with UC. Intervention: Multimodal intervention program including an exercise program, nutritional intervention and psychological evaluation.
Main study parameters/endpoints: This study assesses the feasibility of a multimodal intervention program. Secondary, assesses the effect on:
- Individual patients' level, i.e. physical fitness, nutritional status, mental health, quality of life and work productivity and activity impairment.
- Therapy outcomes, e.g. adherence, number and severity of (S)AEs, corticosteroid use, biochemical and clinical response/remission rates and patient reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age ≥ 18 years old;
- •Diagnosis of UC confirmed by clinical, endoscopic, and/or histological evidence prior to screening as per standard criteria;
- •Ability of subject to participate fully in all aspects of this project;
- •Written informed consent must be obtained and documented.
排除标准
- •Suspicion of differential diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis;
- •Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, certain orthopedic impairments or any unstable, uncontrolled or severe systemic medical disorder);
- •History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures;
- •History of psychiatric disorders that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures;
- •If female, the subject is pregnant or lactating (< 1 year) or intending to become pregnant;
- •Immobilized patients who are not able to complete exercise intervention;
- •Illiteracy (disability to read and understand Dutch).
结局指标
主要结局
Attrition
时间窗: 24 weeks
The percentage of participants who stopped the program prematurely.
Adherence to exercise program
时间窗: 24 weeks
Frequency of followed trainings
Satisfaction
时间窗: 24 weeks
Measured using a patient satisfaction questionnaire
Safety
时间窗: 24 weeks
Measured by the number of adverse events occurring during the program
Adherence to daily exercise goals
时间窗: 24 weeks
SQUASH questionnaire
Accrural
时间窗: 24 weeks
The percentage of approached, eligible participants that are included in the study.
次要结局
- Change in 1 repitition measures(1 year)
- Change in fat-free mass(1 year)
- Change in 36-Item Short Form Health Survey (SF-36) score(1 year)
- Change in EuroQoL (EQ-5D-5L) score(1 year)
- Change in nutritional status(1 year)
- Change in Work Productivity and Activity Impairment(1 year)
- Change in Oxygen Consumption (VO2 max)(1 year)
- Change in body weight(1 year)
- Change in mental health(1 year)
- Change in Inflammatory Bowel Disease Questionnaire score(1 year)