Effects of Exercise on Cognitive Function in Glioma Patients

Tilburg University

Status: Completed

Conditions: Anaplastic Glioma of Brain; Low Grade Glioma of Brain

Treatments: Behavioral: physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02303938

NL44024.008.13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

physical exercise

Experimental group

Description:

Patients will exercise three times per week for 6 months home-based exercise intervention. Session duration will vary between 20 minutes and 45 minutes.

Treatment:

Behavioral: physical exercise

Active control group

No Intervention group

Description:

Patients in the active control group will be advised to walk regularly based on brochures from 30minutenbewegen.nl