Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

Not Applicable

Completed

• Conditions: Neoplasms; CNS Neoplasms
• Interventions: Behavioral: Interdisciplinary rehabilitation

• Registration Number: NCT02221986
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-21
• Study Start: 2015-02-01
• Status Verified: 2017-09
• Primary Completion: 2018-02-14
• Study Completion: 2018-02-14
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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Exclusion Criteria

• Pregnancy
• Known psychiatric diagnosis or substance abuse
• Heart problems excluding intense exercise (NYHA group III and IV)
• Pronounced impressive/expressive aphasia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interdisciplinary rehabilitation	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).

Primary Outcome Measures

Name	Time	Method
Health related quality of life	Change from Baseline HRQoL at 6 months	Questionnaires EORTC-QLQ-30 \& BN-20

Secondary Outcome Measures

Name	Time	Method
Physical activity levels	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	Change from Baseline Musclestrength at 3 months	Assessed through 3-8 submax repetition maximum
VO2peak	Change from Baseline VO2peak at 3 months	Assessed through Åstrand 1-pkt. cycle test.
Balance	Change from Baseline Balance at 3 months	Assessed through wii balance board
Gait function	Change from Baseline gait function at 3 months	Assessed through 10 meter walk test. Time and step frequency.
Activity levels	Change from Baseline Activity levels at 3 months	Assessed through questionnaire (Impact on Participation and Autonomy)
Symptom burden	Change from Baseline Symptom burden at 6 months	Assessed through EORTC-QLQ-30 \& BN-20

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Funen, Denmark