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Clinical Trials/NCT02221986
NCT02221986
Completed
Not Applicable

Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

Odense University Hospital1 site in 1 country64 target enrollmentFebruary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasms
Sponsor
Odense University Hospital
Enrollment
64
Locations
1
Primary Endpoint
Health related quality of life
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The results of the present RCT study will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for patient with glioma.

Detailed Description

Gliomas are the most frequent primary neoplasm in the CNS and according to the World Health Organization histologically categorized into low-grade glioma (LGG) (WHO grades I/II) or high-grade glioma (HGG) (WHO grades III/IV). Gliomas are among the biggest challenges within the field of neuro-rehabilitation and oncology, and optimising treatment by improving QoL, function and cognition is of major clinical importance in this population. Because the majority of patients cannot be cured, clinical cancer research traditionally have focused on prolonging survival, exposing relapse or optimising the response to the medical treatment. Today there is a general consensus that health-related quality of life (HRQoL) is important in the evaluation of new treatments. However, research in HRQoL among patients with gliomas is scarce compared to the other categories of patients with tumors. In recent years have exercise become an important part of cancer treatment. The effects is well documented in studies among other cancer patients than gliomas and includes improvements of quality of life, physical function, reduce fatigue and thereby supports daily activities among cancer patients'. Inpatient rehabilitation studies among glioma patients have also indicated improved HRQoL and functional measurements such as activity of daily life, mobility and cognition. Despite of this rehabilitation efforts is still not emphasized in this population and recent literature concludes that there are no well-designed clinical studies examining the effect of multidisciplinary rehabilitation among Glioma patients. This study is the first to investigate the effect of an intensive specialised interdisciplinary outpatient rehabilitation program among gliomas patients.

Registry
clinicaltrials.gov
Start Date
February 1, 2015
End Date
February 14, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anders Hansen

Physiotherapist, Master of Health Science

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of primary glioma (WHO grades I-IV)
  • Reference with diagnosis or treatment at Odense University Hospital
  • Karnofsky performance score (KPS) ≥70
  • Ability to understand Danish.

Exclusion Criteria

  • Pregnancy
  • Known psychiatric diagnosis or substance abuse
  • Heart problems excluding intense exercise (NYHA group III and IV)
  • Pronounced impressive/expressive aphasia

Outcomes

Primary Outcomes

Health related quality of life

Time Frame: Change from Baseline HRQoL at 6 months

Questionnaires EORTC-QLQ-30 \& BN-20

Secondary Outcomes

  • Physical activity levels(Change from Baseline Physical activity levels at 6 months)
  • Muscle strength(Change from Baseline Musclestrength at 3 months)
  • VO2peak(Change from Baseline VO2peak at 3 months)
  • Balance(Change from Baseline Balance at 3 months)
  • Gait function(Change from Baseline gait function at 3 months)
  • Activity levels(Change from Baseline Activity levels at 3 months)
  • Symptom burden(Change from Baseline Symptom burden at 6 months)

Study Sites (1)

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