Harald Rief1, Lina C Petersen2, Georg Omlor3, Michael Akbar4, Thomas Bruckner5, Stefan Rieken6, Matthias F Haefner7, Ingmar Schlampp8, Robert Förster9, Jürgen Debus10, Thomas Welzel11. 1. Department of Radiation Oncology, University Hospital of Heidelberg, Germany. Electronic address: harald.rief@med.uni-heidelberg.de. 2. Department of Radiation Oncology, University Hospital of Heidelberg, Germany. Electronic address: lina.petersen89@googlemail.com. 3. Department of Orthopaedics and Trauma Surgery, University Hospital of Heidelberg, Germany. Electronic address: georg.omlor@med.uni-heidelberg.de. 4. Department of Orthopaedics and Trauma Surgery, University Hospital of Heidelberg, Germany. Electronic address: michael.akbar@med.uni-heidelberg.de. 5. Department of Medical Biometry, University Hospital of Heidelberg, Germany. Electronic address: bruckner@imbi.uni-heidelberg.de. 6. Department of Radiation Oncology, University Hospital of Heidelberg, Germany. Electronic address: stefan.rieken@med.uni-heidelberg.de. 7. Department of Radiation Oncology, University Hospital of Heidelberg, Germany. Electronic address: matthias.haefner@med.uni-heidelberg.de. 8. Department of Radiation Oncology, University Hospital of Heidelberg, Germany. Electronic address: ingmar.schlampp@med.uni-heidelberg.de. 9. Department of Radiation Oncology, University Hospital of Heidelberg, Germany. Electronic address: robert.foerster@med.uni-heidelberg.de. 10. Department of Radiation Oncology, University Hospital of Heidelberg, Germany. Electronic address: juergen.debus@med.uni-heidelberg.de. 11. Department of Radiation Oncology, University Hospital of Heidelberg, Germany. Electronic address: thomas.welzel@med.uni-heidelberg.de.
Abstract
PURPOSE: To compare the effects of resistance training versus passive physical therapy on bone density in the metastatic bone during radiation therapy (RT) as combined treatment in patients with spinal bone metastases. Secondly, to quantify pathological fractures after combined treatment. MATERIAL AND METHODS: In this randomized trial, 60 patients were allocated from September 2011 until March 2013 into one of the two groups: resistance training (group A) or passive physical therapy (group B) with thirty patients in each group during RT. Bone density in metastatic and non-metastatic vertebral bone was assessed at baseline, 3 and 6 months after RT. RESULTS:Bone density in all metastases increased significantly by 28.3% (IQR 11.4-139.0) and 80.3% (IQR 32.6-250.6) after 3 and 6 months in group A (both p < 0.01). The bone density in group A was significantly increased compared to control group after 3 and 6months (both p < 0.01, median 59.7; IQR 21.1-98.3 and median 62.9; IQR -9.7 to 161.7). The bone density data in group B showed no significant increase over the course of time (p = 0.289, median 5.5, IQR 0.0-62.2 and p = 0.057, median 52.1, IQR 0.0-162.7). 23.3% of the patients in group A and 30.0% of the patients in group B had pathological fractures, no fracture was assigned to intervention, and no difference between groups after 3 and 6 months was observed (p = 0.592 and p = 0.604). CONCLUSIONS: Our trial demonstrated that resistance training concomitant to RT can improve bone density in spinal bone metastases. This combined treatment is effective, practicable, and without side effects for patients. Importantly, the pathological fracture rate in the intervention group was not increased. The results offer a rationale for future large controlled investigations to confirm these findings. TRIAL REGISTRATION: Clinical trial identifier NCT01409720.
RCT Entities:
PURPOSE: To compare the effects of resistance training versus passive physical therapy on bone density in the metastatic bone during radiation therapy (RT) as combined treatment in patients with spinal bone metastases. Secondly, to quantify pathological fractures after combined treatment. MATERIAL AND METHODS: In this randomized trial, 60 patients were allocated from September 2011 until March 2013 into one of the two groups: resistance training (group A) or passive physical therapy (group B) with thirty patients in each group during RT. Bone density in metastatic and non-metastatic vertebral bone was assessed at baseline, 3 and 6 months after RT. RESULTS: Bone density in all metastases increased significantly by 28.3% (IQR 11.4-139.0) and 80.3% (IQR 32.6-250.6) after 3 and 6 months in group A (both p < 0.01). The bone density in group A was significantly increased compared to control group after 3 and 6months (both p < 0.01, median 59.7; IQR 21.1-98.3 and median 62.9; IQR -9.7 to 161.7). The bone density data in group B showed no significant increase over the course of time (p = 0.289, median 5.5, IQR 0.0-62.2 and p = 0.057, median 52.1, IQR 0.0-162.7). 23.3% of the patients in group A and 30.0% of the patients in group B had pathological fractures, no fracture was assigned to intervention, and no difference between groups after 3 and 6 months was observed (p = 0.592 and p = 0.604). CONCLUSIONS: Our trial demonstrated that resistance training concomitant to RT can improve bone density in spinal bone metastases. This combined treatment is effective, practicable, and without side effects for patients. Importantly, the pathological fracture rate in the intervention group was not increased. The results offer a rationale for future large controlled investigations to confirm these findings. TRIAL REGISTRATION: Clinical trial identifier NCT01409720.
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