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

NCT05111834 | Active Not Recruiting

• 1 other identifier: DJCLS 12R/2019
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Vs Host Disease

Keywords

Resistance Training; Nutritional Endorsement; Allogenic stem cell transplantation; Steroid-induced myopathy; Cancer; Exercise; Graft versus host disease; Physical performance

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 24 in Physical performance, as measured by the Short Physical Performance Battery (SPPB)

  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.

  up to 24 weeks (& 6 month follow-up)

Secondary Outcomes (9)

• 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 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 Muscle volume, assessed with ultrasound measurement

  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 Health related Quality of life, as measured by the EORTC QLQ-C30

  up to week 24 (& 6 month follow-up)

Study Arms (2)

Supervised resistance training plus nutritional endorsement

EXPERIMENTAL

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.

Behavioral: Supervised resistance training plus nutritional endorsement

Nutritional endorsement only

ACTIVE COMPARATOR

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

Behavioral: Nutritional endorsement

Interventions

Supervised resistance training plus nutritional endorsement BEHAVIORAL

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

Supervised resistance training plus nutritional endorsement

Nutritional endorsement BEHAVIORAL

nutritional endorsement/therapy based on individual needs

Nutritional endorsement only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Deutsche José Carreras Leukämie-Stiftung: collaborator

Study Sites (1)

Heidelberg University Hospital

Heidelberg, Germany, 69120, Germany

Location

Related Publications (2)

• 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.

  PMID: 39606939 DERIVED

• 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.

  PMID: 35459108 DERIVED

MeSH Terms

Conditions

Graft vs Host Disease; Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Immune System Diseases; Behavior

Study Officials

• Joachim Wiskemann, PD Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 8, 2021
• Study Start: September 15, 2021
• Primary Completion: May 31, 2025
• Study Completion: November 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

DE (1)