Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

April 3, 2018 updated by: Anders Hansen, Odense University Hospital
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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Funen
      • Odense, Funen, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Karen Søgaard, Professor, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

February 14, 2018

Study Completion (ACTUAL)

February 14, 2018

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (ESTIMATE)

August 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

September 1, 2017

More Information

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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