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

NCT02847754 | Unknown Phase 2

• 1 other identifier: DISPO 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Bony Metastases

Keywords

bony metastases; physical exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• progression-free survival (PFS)

  2 years post completion of radiotherapy

• fracture-free survival (FFS)

  2 years post completion of radiotherapy

• bone density

  12 weeks post completion radiotherapy

• pain reduction

  Immediately after completion of radiotherapy, 12 and 24 weeks post completion of radiotherapy

• Quality of life

  12 and 24 weeks post completion of therapy

Study Arms (2)

A

EXPERIMENTAL

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

B

NO INTERVENTION

Patients in arm B (control group) receive 10 daily sessions of 15 min progressive muscle relaxation starting from day one of radiotherapy.

Interventions

Isometric resistance training OTHER

Exercises in the "all-fours" position Exercises in the "swimming" Position Exercises in the "forearm support" Position Exercises with elastic "rubber" band

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Dept of Radiation Oncology, University of Heidelberg, Germany

Heidelberg, Germany, 69120, Germany

Location

Related Publications (13)

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• Welte SE, Wiskemann J, Scharhag-Rosenberger F, Forster R, Bostel T, Bruckner T, Schlampp I, Meyerhof E, Sprave T, Nicolay NH, Debus J, Rief H. Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial. Trials. 2017 Mar 31;18(1):155. doi: 10.1186/s13063-017-1903-x.

  PMID: 28359283 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Harald Rief, MD, PhD

CONTACT

harald.rief@med.uni-heidelberg.de

Jürgen Debus, MD, PhD

CONTACT

juergen.debus@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

DE (1)