IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change from baseline to week 24 in Physical performance, as measured by the Short Physical Performance Battery (SPPB)
研究概览
简要总结
The IRENE-G trial is a randomized controlled study that aims to investigate the effect of a supervised resistance exercise program (2x/week for 24 weeks) in combination with a nutritional intervention on physical performance/frailty in patients with GvHD symptoms treated with high dose steroids.
详细描述
Graft-versus-host disease (GvHD) remains the major complication and limitation to successful allogeneic hematopoietic stem cell transplantation (allo-HSCT). Treatment of GvHD is challenging, with high-dose steroids remaining the established first-line treatment in both acute and chronic GvHD. Long-term doses of systemic corticosteroids have many well-known side-effects such as myopathy, though often an overlooked diagnosis. Previous studies in non-cancer patients treated with corticosteroids demonstrated that resistance training can reverse muscle atrophy and weakness. Despite the beneficial effects of exercise, no research effort to date has explicitly examined the effect of a progressive moderate-to-high intensity resistance training on the physical performance and well-being of GvHD patients treated with high-dose steroids. As GvHD patients are commonly found to be malnourished, which affects muscle mass and strength and thus quality of life, nutritional endorsement and optimization should be considered when investigating the effect of exercise in GvHD patients.
The IRENE-G study (acronym for Impact of Resistance Exercise and Nutritional Endorsement on GvHD symptoms) is a 24 week prospective, randomized controlled intervention trial with a two-armed parallel design and 1:1 allocation ratio of GvHD patients treated with high-dose steroids.The exploratory study examines and compares the effects of a supervised resistance exercise intervention - 2x per week, 60 minutes - and a nutritional optimisation program (experimental group) against a nutritional optimisation program only (control group) on physical performance in GvHD patients treated with high-dose steroids. We hypothesize that patients in the experimental group will show significantly greater improvements (or an attenuated decrement) in their physical performance after 24-weeks compared to the control group. Moreover, the investigators hypothesized that the experimental group will have lower levels of fatigue, a higher perceived quality of life, better muscle strength values and a higher vastus lateralis muscle volume, a better nutritional status as well as a better submaximal endurance capacity compared to the control group.
On the basis of power calculations, the goal is to include 56 patients per intervention arm, resulting in a total patient number of n=112.
Assessments will take place at week 8, 16 and 24 after baseline. A follow-up assessment is planned at week 48.
The primary outcome of IRENE-G is physical performance measured via the Short Physical Performance Battery. Further endpoints are muscle strength and volume, submaximal endurance capacity, nutritional status and patient-reported outcomes such as quality of life and fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Existing or new diagnosis of acute or chronic GvHD treated with systemic steroid therapy (≥0,5 mg/kg/day)
- •Sufficient German language skills
- •Willing/ able to train at the provided exercise facilities or online twice a week
- •Willing/ able to take part in the scheduled testing
- •Capacity to consent
- •Signed informed consent
排除标准
- •Any physical or mental conditions that would hamper the adherence to the training and/or nutritional program or the completion of the study procedures
- •Heart insufficiency > NYHA III or uncertain arrhythmia
- •Uncontrolled hypertension
- •Severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl)
- •Reduced standing or walking ability
- •Insufficient hematological capacity (either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL)
- •Any other comorbidities that preclude participation in the exercise programs
结局指标
主要结局
Change from baseline to week 24 in Physical performance, as measured by the Short Physical Performance Battery (SPPB)
时间窗: up to 24 weeks (& 6 month follow-up)
Physical Performance will be assessed with the Short Physical Performance Battery (SPPB). The SPPB is based on three timed tasks: 4-meter walking speed test, standing balance (feet side-by-side, semi-tandem, full tandem) and sit-to-stand test. Participants score on each component of the battery. Each task is scored out of 4. The sum of the three assessments comprised the final SPPB score with a possible range from 0 to 12. A higher score represents a higher level of function, while lower level indicate lower level of function. Change = (Week 24 Score - Baseline Score). The SPPB is a well-established instrument for the measurement of physical performance, commonly used is elderly patients both in hospital and community setting.
次要结局
- Change from baseline to week 24 in Muscle strength performance, as measured by Hand-held dynamometer(up to week 24 (& 6 month follow-up))
- Change from baseline to week 24 in Functional Status determined with the Karnofsky performance scale(up to week 24 (& 6 month follow-up))
- Change from baseline to week 24 in Nutritional Status(up to week 24 (& 6 month follow-up))
- Change from baseline to week 24 in Submaximal endurance performance, assessed with the 6 minute walk test(up to 24 weeks (& 6 month follow-up))
- Change from baseline to week 24 Health related Quality of life, as measured by the EORTC QLQ-C30(up to week 24 (& 6 month follow-up))
- Change from baseline to week 24 in patient-perceived GVHD symptom bother, as measured by the modified 7-day Lee Chronic-versus-Host Disease Symptom Scale(up to week 24 (& 6 month follow-up))
- Change from baseline to week 24 in high-dose chemotherapy and stem cell transplantation-related symptoms and problems, as measured by the EORTC QLQ-HDC 29(up to week 24 (& 6 month follow-up))
- Change from baseline to week 24 in Muscle volume, assessed with ultrasound measurement(up to week 24 (& 6 month follow-up))
- Change from baseline to week 24 in Cancer-related Fatigue, as measured by the EORTC QLQ-FA12(up to week 24 (& 6 month follow-up))
研究者
Joachim Wiskemann
Principle Investigator
University Hospital Heidelberg