Clinical trial · Interventional
IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms
NCT05111834CI-TRIAL-00085430IRENE-Gactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Vs Host Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional endorsement | Behavioral | — | UNRESOLVED |
| Supervised resistance training plus nutritional endorsement | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Supervised resistance training plus nutritional endorsement
- description
- The study participants receive a progressive moderate-to-high-intensity resistance training program (a 60 minutes twice a week for a period of 24- weeks) plus nutritional endorsement. The training will take place at the NCT Heidelberg, in regional qualified facility centers or online under supervision and guidance of experienced exercise therapists. The progressive resistance program for participants who train at facility centers comprises of 6 machine-based exercises, each performed 2 sets,12 repetitions of 60%-80% of 1 RM. For participants who train online, the training load will be defined during the introductory training session with the aim of choosing a load which to perform two times 12 repetitions. The program targets major upper and lower body muscle groups (with emphasis on the lower extremities). In addition, patients receive nutritional advice/diet modification, depending on their individual requirements and/or changes in general condition.
- interventionNames
- Behavioral: Supervised resistance training plus nutritional endorsement
- type
- ACTIVE_COMPARATOR
- label
- Nutritional endorsement only
- description
- Patients receive nutritional advice/diet modification, depending on their individual requirements and/or changes in general condition.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (2)
- DERIVEDErnst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518. PMID 39606939
- DERIVEDBujan Rivera J, Kuhl R, Zech U, Hendricks A, Luft T, Dreger P, Friedmann-Bette B, Betz TM, Wiskemann J. Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD (IRENE-G study) - design and rational of a randomized controlled trial. BMC Cancer. 2022 Apr 22;22(1):440. doi: 10.1186/s12885-022-09497-1. PMID 35459108