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IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms

NCT05111834 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-02-03

No results posted yet for this study

Summary

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

  • Graft Vs Host Disease

Interventions

BEHAVIORAL

Supervised resistance training plus nutritional endorsement

resistance training 2x per week, nutritional endorsement/therapy based on individual needs

BEHAVIORAL

Nutritional endorsement

nutritional endorsement/therapy based on individual needs

Sponsors & Collaborators

  • Deutsche José Carreras Leukämie-Stiftung

    collaborator UNKNOWN

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Joachim Wiskemann, PD Dr. · Heidelberg University Hospital, National center for Tumor Diseases, Division of Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2025-05-31
Completion
2025-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05111834 on ClinicalTrials.gov