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Completed

NCT Number: NCT02221986

Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

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.

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Key information

Conditions

Neoplasms CNS Neoplasms Central Nervous System Neoplasms Glioma Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, Funen, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interdisciplinary rehabilitation

Behavioral

Primary outcomes

  1. Health related quality of life

    Time frame: Change from Baseline HRQoL at 6 months

    Questionnaires EORTC-QLQ-30 & BN-20

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • University of Southern Denmark

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2014
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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