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

NCT ID: NCT05111834

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2025-11-30

Brief 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.

Detailed Description

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.

Conditions

Graft Vs Host Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supervised resistance training plus nutritional endorsement

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.

Group Type: EXPERIMENTAL

Supervised resistance training plus nutritional endorsement

Intervention Type: BEHAVIORAL

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

Nutritional endorsement only

Patients receive nutritional advice/diet modification, depending on their individual requirements and/or changes in general condition.

Group Type: ACTIVE_COMPARATOR

Nutritional endorsement

Intervention Type: BEHAVIORAL

nutritional endorsement/therapy based on individual needs

Interventions

Supervised resistance training plus nutritional endorsement

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

Intervention Type: BEHAVIORAL

Nutritional endorsement

nutritional endorsement/therapy based on individual needs

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsche José Carreras Leukämie-Stiftung

UNKNOWN

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Joachim Wiskemann

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim Wiskemann, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University Hospital, National center for Tumor Diseases, Division of Medical Oncology

Locations

Heidelberg University Hospital

Heidelberg, Germany, Germany

Countries

Germany

References

Ernst 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.

Reference Type: DERIVED

PMID: 39606939 (View on PubMed)

Bujan 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.

Reference Type: DERIVED

PMID: 35459108 (View on PubMed)

Other Identifiers

DJCLS 12R/2019

Identifier Type: -

Identifier Source: org_study_id