Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interdisciplinary rehabilitation | Experimental | The intervention consists of 6 weeks intensive outpatient physiotherapy in conjunction with 0-6 weeks of occupational therapy if need is indicated. The physical intervention contains supervised group exercise of 90 minutes three times a week in groups up to four patients included continuously. The occupational therapy intervention consists of individual training 60 minutes twice a week for patients having deficits in activity or participation levels measured by the Assessment of Motor and Process Skills (AMPS). |
|
| Care as usual | No Intervention | The control group receives usual standard of care (e.g. no training, individual training or group training in the municipality). The amount of training in this group is based on a questionnaire at the follow-up trials. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interdisciplinary rehabilitation | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | Questionnaires EORTC-QLQ-30 & BN-20 | Change from Baseline HRQoL at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom burden | Assessed through EORTC-QLQ-30 & BN-20 | Change from Baseline Symptom burden at 6 months |
| Physical activity levels | Physical activity at work and leisure time ( Assessed through questionnaire by Saltin and Grimsby 1968 and Physical Activity Scale) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen Søgaard, Professor | University of Southern Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | Funen | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32043148 | Derived | Hansen A, Pedersen CB, Jarden JO, Beier D, Minet LR, Sogaard K. Effectiveness of Physical Therapy- and Occupational Therapy-Based Rehabilitation in People Who Have Glioma and Are Undergoing Active Anticancer Treatment: Single-Blind, Randomized Controlled Trial. Phys Ther. 2020 Mar 10;100(3):564-574. doi: 10.1093/ptj/pzz180. | |
| 31818840 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change from Baseline Physical activity levels at 6 months |
| Muscle strength | Assessed through 3-8 submax repetition maximum | Change from Baseline Musclestrength at 3 months |
| VO2peak | Assessed through Åstrand 1-pkt. cycle test. | Change from Baseline VO2peak at 3 months |
| Balance | Assessed through wii balance board | Change from Baseline Balance at 3 months |
| Gait function | Assessed through 10 meter walk test. Time and step frequency. | Change from Baseline gait function at 3 months |
| Activity levels | Assessed through questionnaire (Impact on Participation and Autonomy) | Change from Baseline Activity levels at 3 months |
| Fahrenholtz ML, Hansen A, Sogaard K, Andersen LN. Finding 'the inner drive' for a rehabilitation process: a small-scale qualitative investigation among male patients with primary glioma. BMJ Open. 2019 Dec 8;9(12):e031665. doi: 10.1136/bmjopen-2019-031665. |
| 25280804 | Derived | Hansen A, Rosenbek Minet LK, Sogaard K, Jarden JO. The effect of an interdisciplinary rehabilitation intervention comparing HRQoL, symptom burden and physical function among patients with primary glioma: an RCT study protocol. BMJ Open. 2014 Oct 3;4(10):e005490. doi: 10.1136/bmjopen-2014-005490. |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |