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
Abstract 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 trea...
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| Format: | Article |
| Language: | English |
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BMC
2022-04-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-022-09497-1 |
| _version_ | 1818060541433741312 |
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| author | Janina Bujan Rivera Rea Kühl Ulrike Zech Anne Hendricks Thomas Luft Peter Dreger Birgit Friedmann-Bette Theresa-Maria Betz Joachim Wiskemann |
| author_facet | Janina Bujan Rivera Rea Kühl Ulrike Zech Anne Hendricks Thomas Luft Peter Dreger Birgit Friedmann-Bette Theresa-Maria Betz Joachim Wiskemann |
| author_sort | Janina Bujan Rivera |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-10T13:34:04Z |
| format | Article |
| id | doaj.art-01bed7b3e18e4af79555303eb0ed4e4f |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-10T13:34:04Z |
| publishDate | 2022-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-01bed7b3e18e4af79555303eb0ed4e4f2022-12-22T01:46:51ZengBMCBMC Cancer1471-24072022-04-0122111510.1186/s12885-022-09497-1Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD (IRENE-G study) – design and rational of a randomized controlled trialJanina Bujan Rivera0Rea Kühl1Ulrike Zech2Anne Hendricks3Thomas Luft4Peter Dreger5Birgit Friedmann-Bette6Theresa-Maria Betz7Joachim Wiskemann8Division of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital HeidelbergDivision of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital HeidelbergDepartment of Internal Medicine I, University Hospital HeidelbergDepartment of Internal Medicine I, University Hospital HeidelbergDepartment of Internal Medicine V, University Hospital HeidelbergDepartment of Internal Medicine V, University Hospital HeidelbergDepartment of Internal Medicine VII, University Hospital HeidelbergDepartment of Internal Medicine III, University Hospital HeidelbergDivision of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital HeidelbergAbstract 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.https://doi.org/10.1186/s12885-022-09497-1CancerExerciseGraft-versus-host diseaseGlucocorticoidsResistance trainingNutritional endorsement |
| spellingShingle | Janina Bujan Rivera Rea Kühl Ulrike Zech Anne Hendricks Thomas Luft Peter Dreger Birgit Friedmann-Bette Theresa-Maria Betz Joachim Wiskemann 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 Cancer Exercise Graft-versus-host disease Glucocorticoids Resistance training Nutritional endorsement |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Cancer Exercise Graft-versus-host disease Glucocorticoids Resistance training Nutritional endorsement |
| url | https://doi.org/10.1186/s12885-022-09497-1 |
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