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Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221986
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Anders Hansen, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Neoplasms CNS Neoplasms Behavioral: Interdisciplinary rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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).

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.



Primary Outcome Measures :
  1. Health related quality of life [ Time Frame: Change from Baseline HRQoL at 6 months ]
    Questionnaires EORTC-QLQ-30 & BN-20


Secondary Outcome Measures :
  1. Symptom burden [ Time Frame: Change from Baseline Symptom burden at 6 months ]
    Assessed through EORTC-QLQ-30 & BN-20

  2. 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)

  3. Muscle strength [ Time Frame: Change from Baseline Musclestrength at 3 months ]
    Assessed through 3-8 submax repetition maximum

  4. VO2peak [ Time Frame: Change from Baseline VO2peak at 3 months ]
    Assessed through Åstrand 1-pkt. cycle test.

  5. Balance [ Time Frame: Change from Baseline Balance at 3 months ]
    Assessed through wii balance board

  6. Gait function [ Time Frame: Change from Baseline gait function at 3 months ]
    Assessed through 10 meter walk test. Time and step frequency.

  7. Activity levels [ Time Frame: Change from Baseline Activity levels at 3 months ]
    Assessed through questionnaire (Impact on Participation and Autonomy)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
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Study Chair: Karen Søgaard, Professor University of Southern Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anders Hansen, Physiotherapist, Master of Health Science, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02221986    
Other Study ID Numbers: S-20140108
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: September 2017
Keywords provided by Anders Hansen, Odense University Hospital:
Interdisciplinary rehabilitation
Neurooncology
Physiotherapy
Occupational therapy
Neurorehabilitation
Glioma
Additional relevant MeSH terms:
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Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue