Effects of Exercise on Cognitive Function in Glioma Patients

August 3, 2015 updated by: Karin Gehring, Tilburg University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months after the initial assessment
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)
Time Frame: 6 months after the initial assessment
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
Time Frame: 6 months after the initial assessment
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)
Time Frame: 6 months after the initial assessment
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
Time Frame: 6 months after the initial assessment
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

This is where you will find people and organizations involved with this study.

Sponsor

Tilburg University

Investigators

  • Principal Investigator: Karin Gehring, PhD, Tilburg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • NL44024.008.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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