Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment
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|ClinicalTrials.gov Identifier: NCT02221986|
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms CNS Neoplasms||Behavioral: Interdisciplinary rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment|
|Actual Study Start Date :||February 1, 2015|
|Actual Primary Completion Date :||February 14, 2018|
|Actual Study Completion Date :||February 14, 2018|
Experimental: Interdisciplinary rehabilitation
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).
Behavioral: Interdisciplinary rehabilitation
No Intervention: Care as usual
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.
- Health related quality of life [ Time Frame: Change from Baseline HRQoL at 6 months ]Questionnaires EORTC-QLQ-30 & BN-20
- Symptom burden [ Time Frame: Change from Baseline Symptom burden at 6 months ]Assessed through EORTC-QLQ-30 & BN-20
- Physical activity levels [ Time Frame: 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 [ Time Frame: Change from Baseline Musclestrength at 3 months ]Assessed through 3-8 submax repetition maximum
- VO2peak [ Time Frame: Change from Baseline VO2peak at 3 months ]Assessed through Åstrand 1-pkt. cycle test.
- Balance [ Time Frame: Change from Baseline Balance at 3 months ]Assessed through wii balance board
- Gait function [ Time Frame: Change from Baseline gait function at 3 months ]Assessed through 10 meter walk test. Time and step frequency.
- Activity levels [ Time Frame: Change from Baseline Activity levels at 3 months ]Assessed through questionnaire (Impact on Participation and Autonomy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221986
|Odense University Hospital|
|Odense, Funen, Denmark, 5000|
|Study Chair:||Karen Søgaard, Professor||University of Southern Denmark|