Effects of Exercise on Cognitive Function in Glioma Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Grade Glioma of Brain, Anaplastic Glioma of Brain

Intervention / Treatment
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* Behavioral: physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade II and III gliomas age < 50 years Karnofsky score > or equal 80 clinically stable for a minimum of 6 months prior to study entry no recent anti-tumor treatment interested in undergoing a physical exercise program mild to moderate neuropsychological impairment based on normative comparison of objective test performance relative VO2peak that leaves room for further improvement of cardiorespiratory fitness. Exclusion Criteria: patients with serious orthopedic conditions or motor deficits patients with serious cardiovascular, cardiopulmonary and neurological conditions (or risks) patients judged to have psychiatric (including alcohol and drug abuse) patients with severe cognitive problems patients who report to engage in vigorous exercise (≥7 METs) for more than 20 minutes on at least 3 days per week on a regular basis will be excluded For assessment purposes, study participants will need to have basic fluency in the Dutch language.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical exercise<br>Patients will exercise three times per week for 6 months home-based exercise intervention. Session duration will vary between 20 minutes and 45 minutes. | Behavioral: physical exercise<br>* 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.<br>|
| No Intervention: Active control group<br>Patients in the active control group will be advised to walk regularly based on brochures from 30minutenbewegen.nl | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function as measured by neuropsychological tests | neuropsychological test battery will be administered to patients at baseline and immediately after the intervention at 6 months | 6 months after the initial assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective measures of physical fitness measured by cardiopulmonary exercise test (CPET) | Intervention-related improvement of physical fitness will be assessed with a maximum cardiopulmonary exercise test (CPET). VO2 and of course adverse events are recorded immediately after the intervention ended at 6 months | 6 months after the initial assessment |