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.

BACKGROUND: Graft-versus-host disease (GvHD) remains a major complication and limitation to successful allogeneic hematopoietic stem cell transplantation. Treatment of GvHD is challenging due to its heterogeneous nature of presentation, with steroids remaining the established first-line treatment. Long-term doses of systemic corticosteroids have many well-known side-effects including muscle atrophy. Despite the fact that reports in non-cancer clinical populations treated with glucocorticoids demonstrated that resistance training can reverse atrophy and weakness, no RCT has evaluated the potential of resistance training on preventing the disease- and treatment-induced loss of skeletal muscle mass and function in GvHD patients yet. In this context, ensuring adequate nutrition is important as protein deprivation may accelerate the wasting process. As GvHD patients are commonly found to be malnourished, nutritional medical care should be considered when investigating the effect of exercise in GvHD patients. Therefore, the aim of the present "Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD" - Study (IRENE-G) is to evaluate the effects of resistance exercise in combination with nutritional endorsement on physical, nutritional and patient-reported outcomes in GvHD patients. METHODS: IRENE-G is a 24-week prospective interventional RCT. One hundred twelve participants will be randomly allocated (1:1) to one of two arms: resistance exercise and nutritional optimization (experimental) vs. nutritional optimization only (control). Participants in the experimental group will engage in a supervised, progressive moderate-to-high intensity resistance training that is consistent with exercise guidelines for cancer patients, while additionally receiving nutritional support/therapy. Subjects of the control group solely receive nutritional support/therapy based on individual needs. Participants will be assessed at baseline, at 8, 16, 24 weeks for physical performance and various physiological, nutritional and patient-reported outcomes. Follow-up will be 6 months after intervention completion. DISCUSSION: To our knowledge, this will be the first RCT to assess and compare the effects of a resistance intervention supplemented by nutritional support/therapy against nutritional support only on various health-related outcomes in GvHD patients. The study will contribute to our understanding of the value of exercise and nutritional endorsement in counteracting the negative consequences of GvHD and its treatment. TRIAL REGISTRATION: ClinicalTrials.gov : NCT05111834 . Registered 8 November 2021 - Retrospectively registered.

Reliability and validity of a standardised ultrasound examination protocol to quantify vastus lateralis muscle.

OBJECTIVE: To evaluate the reliability and validity of a standardized ultrasound examination protocol for measuring vastus lateralis muscle size. DESIGN: Prospective cohort study. SUBJECTS: Sixteen staff members of the university hospital of Heidelberg. METHODS: Muscle thickness, cross-sectional area and subcutaneous adipose tissue thickness were measured at 3 standardized sites on the right and left vastus lateralis muscle. Ultrasound measurements were collected by 2 independent investigators on 2 different days and compared with magnetic resonance imaging measurements. RESULTS: Intraclass correlation coefficients (ICC) for intra- and inter-rater reliability showed very good closeness of agreement for all parameters (ICC = 0.929-0.994, p < 0.001). Muscle thickness and subcutaneous adipose tissue thickness ultrasound and magnetic resonance imaging measurements revealed good to very good closeness of agreement (ICC = 0.835-0.969, p < 0.001), whereas cross-sectional area showed only average closeness of agreement (ICC = 0.727, p < 0.001). A strong predictive positive correlation for ultrasound and magnetic resonance imaging-based measurements of cross-sectional area was found (R² = 0.793, p < 0.001). CONCLUSION: By standardization of an examination protocol, quantitative vastus lateralis muscle ultrasound proved to be a reliable method for assessing vastus lateralis muscle size. Furthermore, this protocol is valid for measuring muscle thickness and subcutaneous adipose tissue thickness, although there seems to be a systematic underestimation of cross-sectional area depending on subcutaneous adipose tissue thickness.