Clinical trial NCT02303938: Effects of Exercise on Cognitive Function in Glioma Patients
Official title: A Pilot Randomized Controlled Trial on the Feasibility and Efficacy of an Exercise Intervention to Improve Cognitive Functioning in Patients With Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Grade Glioma of Brain
Anaplastic Glioma of Brain
Lead sponsor: Tilburg University
Sponsor class: OTHER
First posted: 2014-12-01
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: cognitive function as measured by neuropsychological tests
timeFrame: 6 months after the initial assessment
Secondary outcomes:
measure: Objective measures of physical fitness measured by cardiopulmonary exercise test (CPET)
timeFrame: 6 months after the initial assessment
Other outcomes:
measure: Patient reported outcome measured with self-reported questionnaires
timeFrame: 6 months after the initial assessment
measure: Subjective cognition measured with Cognitive Functioning Scale (CFS) and Cognitive Failures Questionnaire (CFQ)
timeFrame: 6 months after the initial assessment
measure: Mental well-being measured with self-reported questionnaires
timeFrame: 6 months after the initial assessment
Locations:
city: Tilburg
country: Netherlands
facility: Tilburg University
state: Nood-Brabant
Study officials:
affiliation: Tilburg University
name: Karin Gehring, PhD
role: PRINCIPAL_INVESTIGATOR
References: