CNS Neoplasms, Neoplasms
Conditions
Keywords
Interdisciplinary rehabilitation, Neurooncology, Physiotherapy, Occupational therapy, Neurorehabilitation, Glioma
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.
Interventions
BEHAVIORALInterdisciplinary rehabilitation
Sponsors
University of Southern Denmark
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary glioma (WHO grades I-IV) * Age ≥ 18 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life | Change from Baseline HRQoL at 6 months | Questionnaires EORTC-QLQ-30 & BN-20 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity levels | Change from Baseline Physical activity levels at 6 months | Physical activity at work and leisure time ( Assessed through questionnaire by Saltin and Grimsby 1968 and Physical Activity Scale) |
| Muscle strength | Change from Baseline Musclestrength at 3 months | Assessed through 3-8 submax repetition maximum |
| VO2peak | Change from Baseline VO2peak at 3 months | Assessed through Åstrand 1-pkt. cycle test. |
| Symptom burden | Change from Baseline Symptom burden at 6 months | Assessed through EORTC-QLQ-30 & BN-20 |
| Gait function | Change from Baseline gait function at 3 months | Assessed through 10 meter walk test. Time and step frequency. |
| Activity levels | Change from Baseline Activity levels at 3 months | Assessed through questionnaire (Impact on Participation and Autonomy) |
| Balance | Change from Baseline Balance at 3 months | Assessed through wii balance board |
Countries
Denmark
Outcome results
None listed