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Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy


Phase 2
18 Years
80 Years
Not Enrolling
Both
Vertebral Bony Metastases

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Trial Information

Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy


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 was designed to investigate the impact of
tailored physical exercise in patients with vertebral metastases as compared to manual
therapy (massage etc.). 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 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.

Patients in arm B (control group) receive 10 daily sessions of 15 min manual therapy (i.e.
massage, etc) 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.


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 inititated

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

feasibility of isometric exercise in vertebral bony metastases

Outcome Description:

safety and feasibility of isometric exercise in vertebral bony metastases

Outcome Time Frame:

12 weeks post completion of radiotherapy

Safety Issue:

Yes

Principal Investigator

Juergen Debus, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg

Authority:

University of Heidelberg, Germany: Ethics committee

Study ID:

DISPO

NCT ID:

NCT01409720

Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Vertebral Bony Metastases
  • bony metastases
  • physical exercise
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

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