Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy

Study Overview
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Brief Summary
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Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures. Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support Radiation therapy and improve above named factors. DISPO-2 was designed to investigate the impact of tailored physical exercise in patients with unstable vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful unstable bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.

Detailed Description
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Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures. Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO-2 was designed to investigate the impact of tailored physical exercise in patients with unstable vertebral metastases as compared to manual therapy (progressive muscle relaxation). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design. Patients are randomized to one of the following groups: patients in arm A carry out daily physical training consisting of four different isometric exercises under the guidance and supervision of a physiotherapist. Training starts day one (first radiotherapy session), 10 daily units of 30 min each are scheduled during radiotherapy. Patients are expected to continue training until 12 weeks post completion of radiotherapy at home. Patients in arm B (control group) receive 10 daily sessions of 15 min progressive muscle relaxation starting from day one of radiotherapy. Follow-up of the patients is scheduled at 12 weeks post completion of radiotherapy incl. CT of the spine and physical examination.

Official Title
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Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy

Conditions
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Vertebral Bony Metastases

Intervention / Treatment
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* Other: Isometric resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: solitary or multiple vertebral metastases thoracic spine lumbar spine sacrum indication for palliative radiation therapy age: 18 - 80 years Karnofsky index > 70% bisphosphonate therapy initiated Exclusion Criteria: bony metastases of cervical spine or pelvis impending fracture other serious illnesses or medical conditions: therapy-refractory unstable heart disease, congestive heart failure NYHA °III and °IV; coagulopathies Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators Legal incapacity or limited legal capacity Positive serum/ urine beta-HCG/ pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>A patients in arm A carry out daily physical Training consisting of three different isometric exercises under the guidance and supervision of a physiotherapist. Training starts day one (first radiotherapy session), 10 daily units of 30 min each are scheduled during radiotherapy. Patients are expected to continue training until 12 weeks post completion of radiotherapy at home. exercise tailored isometric physical exercise | Other: Isometric resistance training<br>* Exercises in the all-fours position Exercises in the swimming Position Exercises in the forearm support Position Exercises with elastic rubber band<br>|
| No Intervention: B<br>Patients in arm B (control group) receive 10 daily sessions of 15 min progressive muscle relaxation starting from day one of radiotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of isometric exercise in unstable vertebral bony metastases | completion of all isometric exercises until 12 weeks post RT | 12 weeks post completion of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival (PFS) | PFS is assessed 2 years post completion of radiotherapy | 2 years post completion of radiotherapy | 
| fracture-free survival (FFS) | FFS is assessed 2 years post completion of radiotherapy | 2 years post completion of radiotherapy | 
| bone density | bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine | 12 weeks post completion radiotherapy | 
| pain reduction | pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation | Immediately after completion of radiotherapy, 12 and 24 weeks post completion of radiotherapy | 
| Quality of life | Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment | 12 and 24 weeks post completion of therapy | 
| Fatigue | Fatigue is assessed using the EORTC FA13 questionnaire | 12 and 24 weeks post completion of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bony metastases, physical exercise