Supervised resistance training plus nutritional endorsementNutritional endorsement
Supervised resistance training plus nutritional endorsement: resistance training 2x per week, nutritional endorsement/therapy based on individual needs
Nutritional endorsement: nutritional endorsement/therapy based on individual needs
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline to week 24 in Physical performance, as measured by the Short Physical Performance Battery (SPPB) — up to 24 weeks (& 6 month follow-up) 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.
Trial sites (1)
Facility
City
Region
Status
Heidelberg University Hospital
Heidelberg
Germany
More University Hospital Heidelberg trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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