Isometric Muscle Training in Patients With Spinal Bony Metastases Under Radiation Therapy

NCT01409720 | Completed Phase 2

• 1 other identifier: DISPO
• 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 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.

Conditions

Vertebral Bony Metastases

Keywords

bony metastases; physical exercise

Outcome Measures

Primary Outcomes (1)

• feasibility of isometric exercise in vertebral bony metastases

  safety and feasibility of isometric exercise in vertebral bony metastases

  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

  end of treatment, 12 and 24 weeks post completion of radiotherapy

• Quality of life

  12 and 24 weeks post completion of therapy

Study Arms (2)

A

EXPERIMENTAL

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.

Other: exercise

B

NO INTERVENTION

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.

Interventions

exercise OTHER

tailored isometric physical exercise

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 inititated

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

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• Rief H, Bruckner T, Schlampp I, Bostel T, Welzel T, Debus J, Forster R. Resistance training concomitant to radiotherapy of spinal bone metastases - survival and prognostic factors of a randomized trial. Radiat Oncol. 2016 Jul 27;11:97. doi: 10.1186/s13014-016-0675-x.

  PMID: 27464793 DERIVED

• Rief H, Omlor G, Akbar M, Bruckner T, Rieken S, Forster R, Schlampp I, Welzel T, Bostel T, Roth HJ, Debus J. Biochemical markers of bone turnover in patients with spinal metastases after resistance training under radiotherapy--a randomized trial. BMC Cancer. 2016 Mar 17;16:231. doi: 10.1186/s12885-016-2278-1.

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• Rief H, Akbar M, Keller M, Omlor G, Welzel T, Bruckner T, Rieken S, Hafner MF, Schlampp I, Gioules A, Debus J. Quality of life and fatigue of patients with spinal bone metastases under combined treatment with resistance training and radiation therapy- a randomized pilot trial. Radiat Oncol. 2014 Jul 7;9:151. doi: 10.1186/1748-717X-9-151.

  PMID: 24998293 DERIVED

• Rief H, Welzel T, Omlor G, Akbar M, Bruckner T, Rieken S, Haefner MF, Schlampp I, Gioules A, Debus J. Pain response of resistance training of the paravertebral musculature under radiotherapy in patients with spinal bone metastases--a randomized trial. BMC Cancer. 2014 Jul 5;14:485. doi: 10.1186/1471-2407-14-485.

  PMID: 24996223 DERIVED

• Rief H, Heinhold M, Bruckner T, Schlampp I, Forster R, Welzel T, Bostel T, Debus J, Rieken S; German Bone Research Group. Quality of life, fatigue and local response of patients with unstable spinal bone metastases under radiation therapy--a prospective trial. Radiat Oncol. 2014 Jun 11;9:133. doi: 10.1186/1748-717X-9-133.

  PMID: 24917420 DERIVED

• Rief H, Omlor G, Akbar M, Welzel T, Bruckner T, Rieken S, Haefner MF, Schlampp I, Gioules A, Habermehl D, von Nettelbladt F, Debus J. Feasibility of isometric spinal muscle training in patients with bone metastases under radiation therapy - first results of a randomized pilot trial. BMC Cancer. 2014 Feb 5;14:67. doi: 10.1186/1471-2407-14-67.

  PMID: 24499460 DERIVED

• Rief H, Jensen AD, Bruckner T, Herfarth K, Debus J. Isometric muscle training of the spine musculature in patients with spinal bony metastases under radiation therapy. BMC Cancer. 2011 Nov 9;11:482. doi: 10.1186/1471-2407-11-482.

  PMID: 22070722 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juergen Debus, MD PhD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 4, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2011-08

Locations

DE (1)