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Completed

NCT Number: NCT01409720

Isometric Muscle Training 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept of Radiation Oncology, University of Heidelberg, Germany

Heidelberg, Germany, 69120

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

tailored isometric physical exercise

Primary outcomes

  1. feasibility of isometric exercise in vertebral bony metastases

    Time frame: 12 weeks post completion of radiotherapy

    safety and feasibility of isometric exercise in vertebral bony metastases

Secondary outcomes

  1. progression-free survival (PFS)

    Time frame: 2 years post completion of radiotherapy

    PFS is assessed 2 years post completion of radiotherapy

  2. fracture-free survival (FFS)

    Time frame: 2 years post completion of radiotherapy

    FFS is assessed 2 years post completion of radiotherapy

  3. bone density

    Time frame: 12 weeks post completion radiotherapy

    bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine

  4. pain reduction

    Time frame: end of treatment, 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 therapy

  5. Quality of life

    Time frame: 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

  6. Fatigue

    Time frame: 12 and 24 weeks post completion of therapy

    Fatigue is assessed using the EORTC FA13 questionnaire

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Acronym: DISPO

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 4, 2011
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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