NCT02303938

Effects of Exercise on Cognitive Function in Glioma Patients

A Pilot Randomized Controlled Trial on the Feasibility and Efficacy of an Exercise Intervention to Improve Cognitive Functioning in Patients With Glioma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tilburg University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Low Grade Glioma of Brain
• Anaplastic Glioma of Brain

Interventions

Type	Name	Description
BEHAVIORAL	physical exercise	Patients in the intervention group will undergo a 6-month home-based exercise intervention. 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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-12-01
• Last updated: 2015-08-04

Locations

1 site across 1 country: Netherlands