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Completed

NCT Number: NCT02303938

Effects of Exercise on Cognitive Function in Glioma Patients

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.

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Key information

Conditions

Low Grade Glioma of Brain Anaplastic Glioma of Brain

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tilburg University

Tilburg, Nood-Brabant, 5037 AB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exercise

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Tilburg University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2014
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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