Low Grade Glioma of Brain Clinical Trial
Official title:
A Pilot Randomized Controlled Trial on the Feasibility and Efficacy of an Exercise Intervention to Improve Cognitive Functioning in Patients With Glioma
The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility and to determine the effect size of an exercise program in improving objective cognitive functioning.
Clinical stable patients with 1) low grade glioma (LGG) or 2) anaplastic glioma under age 70
will undergo a home-based exercise program (intervention) or will be assigned to the active
controle group. Patients in the intervention group will undergo a 6-month home-based
exercise intervention. An individual exercise prescription will be based on the patients'
level of aerobic fitness (VO2peak) as measured with cardiopulmonary testing (CPET; on a
cycle ergometer with ECG and gas exchange measurement) at baseline. Patients will exercise
(e.g., running, biking, swimming) three times per week for 6 months. Session duration will
vary between 20 minutes and 45 minutes. Patients in the active control group will be advised
to walk regularly based on brochures from 30minutenbewegen.nl.
All primary and secondary outcomes will be assessed at baseline (T0; prior to
randomization), and at completion of the 6-month exercise intervention (T1), and at a
similar time-point for patients in the active control group. These will include indicators
of feasibility (accrual, adherence, compliance and attrition), subjective and objective
physical fitness measures, neuropsychological performance scores, and self-reported
cognitive symptoms and mental wellbeing.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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