Effects of Exercise on Cognitive Function in Glioma Patients

NCT ID: NCT02303938

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

physical exercise

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

Group Type: EXPERIMENTAL

physical exercise

Intervention Type: BEHAVIORAL

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.

Active control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tilburg University

OTHER

Sponsor Role: lead

Responsible Party

Karin Gehring

Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Gehring, PhD

Role: PRINCIPAL_INVESTIGATOR

Tilburg University

Locations

Tilburg University

Tilburg, Nood-Brabant, Netherlands

Countries

Netherlands

Other Identifiers

NL44024.008.13

Identifier Type: -

Identifier Source: org_study_id