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

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.

Study Overview

• Status: Completed
• Conditions: Low Grade Glioma of Brain; Anaplastic Glioma of Brain
• Intervention / Treatment: Behavioral: physical exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nood-Brabant
    • Tilburg, Nood-Brabant, Netherlands, 5037 AB
      • Tilburg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Active control group; Patients in the active control group will be advised to walk regularly based on brochures from 30minutenbewegen.nl

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome measured with self-reported questionnaires	mood, sleep, fatique, quality of life, and depression are measured with self-reported questionaires at baseline and after intervention at 6 months such as Profile of Mood States (POMS) brief, Multidimensional Fatigue Inventory (MFI), Pittsburgh Sleep Inventory, MOS SF-36 Item Health Survey SF-36, and Brain-cancer specific HRQL questionnaire (QLQ-BN20)	6 months after the initial assessment
Subjective cognition measured with Cognitive Functioning Scale (CFS) and Cognitive Failures Questionnaire (CFQ)	Subjective cognition is measured with self-reported questionaire at baseline and after intervention at 6 months	6 months after the initial assessment
Mental well-being measured with self-reported questionnaires	Mental well-being is measured with specific questionaire at baseline and after intervention at 6 months	6 months after the initial assessment

Collaborators and Investigators

• Sponsor: Tilburg University
• Investigators: Principal Investigator: Karin Gehring, PhD, Tilburg University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Estimate): August 4, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: NL44024.008.13