IRENE-G Study

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. Unfortunately, usage of corticosteroids is associated with a variety of side-effects, especially at higher doses and with longer duration of therapy, such as osteoporosis, osteonecrosis, diabetes and myopathy. 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. 

The IRENE-G study (acronym for Impact of Resistance Exercise and Nutritional Endorsement on GvHD symptoms) addresses the research gap and aims to examine the effect of a progressive moderate-to-high intensity resistance exercise program (2x/week for a total duration of 24 weeks) in combination with nutritional optimization on physical performance in GvHD patients treated with high-dose steroid therapy. The results of the IRENE- G study will enhance our understanding of the effectiveness of exercise interventions in combination with structured nutritional therapy measures for acute and chronic GvHD.

Upon written informed consent, eligible patients will be randomly assigned to the experimental or control group. Patients in the experimental group will take part in a 24-week supervised resistance exercise program and a nutritional optimization program. The moderate-to-high intensity resistance exercise sessions will be performed for a duration of 60 min two times a week and can be either executed online, at the NCT Heidelberg or at cooperation partners close to patients’ home. Patients in the control group receive nutritional optimization only. Our therapists, including those from cooperating institutions, will guide the patients and support them during the entire 24 weeks. The interventions will start directly after the completion of the baseline measurements (t0). Further assessments will take place 8 weeks (t1), 16 weeks (t2), and 24 weeks (t3, primary endpoint assessment) after baseline assessment.  A follow-up assessment (t4) is planned 48 weeks after baseline. All assessment points are embedded into medical care/ outpatient visits. Each assessment will take about 1.5 hours and will include a questionnaire set, physical fitness tests, and a survey of patients nutritional status.

The goal is to recruit 112 patients within an inclusion period of 2.5 years. Recruitment will take place at the University Hospital in Heidelberg - Section stem cell transplantation.

The study is funded by the German José Carreras Leukemia Foundation.

Currently recruiting. The recruitment phase started in September 2021 and is expected to be completed within 2.5 years.

• Study Aim: The aim of the IRENE-G study is to investigate whether loss of physical fitness and muscle strength can be reduced by optimized nutrition and targeted, supervised strength training.

• Study training:

  • Group 1: 2x/week supervised strength training + optimized diet for 24 weeks.

  • Group 2: optimized diet for 24 weeks

• Study Patients:
  GvHD patients, treated with glucocorticoids