Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy
- Conditions
- Vertebral Bony Metastases
- Interventions
- Other: Isometric resistance training
- Registration Number
- NCT02847754
- Lead Sponsor
- Heidelberg University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Isometric resistance training 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
- Primary Outcome Measures
Name Time Method feasibility of isometric exercise in unstable vertebral bony metastases 12 weeks post completion of radiotherapy completion of all isometric exercises until 12 weeks post RT
- Secondary Outcome Measures
Name Time Method progression-free survival (PFS) 2 years post completion of radiotherapy PFS is assessed 2 years post completion of radiotherapy
pain reduction Immediately after completion of radiotherapy, 12 and 24 weeks post completion of radiotherapy pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation
bone density 12 weeks post completion radiotherapy bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
Quality of life 12 and 24 weeks post completion of therapy Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment
fracture-free survival (FFS) 2 years post completion of radiotherapy FFS is assessed 2 years post completion of radiotherapy
Fatigue 12 and 24 weeks post completion of therapy Fatigue is assessed using the EORTC FA13 questionnaire
Trial Locations
- Locations (1)
Dept of Radiation Oncology, University of Heidelberg, Germany
🇩🇪Heidelberg, Germany