- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02221986
Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Funen
-
Odense, Funen, Denmark, 5000
- Odense University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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). |
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: Change from Baseline HRQoL at 6 months
|
Questionnaires EORTC-QLQ-30 & BN-20
|
Change from Baseline HRQoL at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom burden
Time Frame: Change from Baseline Symptom burden at 6 months
|
Assessed through EORTC-QLQ-30 & BN-20
|
Change from Baseline Symptom burden at 6 months
|
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)
|
Change from Baseline Physical activity levels at 6 months
|
Muscle strength
Time Frame: Change from Baseline Musclestrength at 3 months
|
Assessed through 3-8 submax repetition maximum
|
Change from Baseline Musclestrength at 3 months
|
VO2peak
Time Frame: Change from Baseline VO2peak at 3 months
|
Assessed through Åstrand 1-pkt.
cycle test.
|
Change from Baseline VO2peak at 3 months
|
Balance
Time Frame: Change from Baseline Balance at 3 months
|
Assessed through wii balance board
|
Change from Baseline Balance at 3 months
|
Gait function
Time Frame: Change from Baseline gait function at 3 months
|
Assessed through 10 meter walk test.
Time and step frequency.
|
Change from Baseline gait function at 3 months
|
Activity levels
Time Frame: Change from Baseline Activity levels at 3 months
|
Assessed through questionnaire (Impact on Participation and Autonomy)
|
Change from Baseline Activity levels at 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Karen Søgaard, Professor, University of Southern Denmark
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20140108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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