Effects of Exercise on Cognitive Function in Glioma Patients
Primary Purpose
Low Grade Glioma of Brain, Anaplastic Glioma of Brain
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Low Grade Glioma of Brain
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.
Sites / Locations
- Tilburg University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
physical exercise
Active control group
Arm Description
Patients will exercise three times per week for 6 months home-based exercise intervention. 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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02303938
Brief Title
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tilburg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Glioma of Brain, Anaplastic Glioma of Brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physical exercise
Arm Type
Experimental
Arm Description
Patients will exercise three times per week for 6 months home-based exercise intervention. Session duration will vary between 20 minutes and 45 minutes.
Arm Title
Active control group
Arm Type
No Intervention
Arm Description
Patients in the active control group will be advised to walk regularly based on brochures from 30minutenbewegen.nl
Intervention Type
Behavioral
Intervention Name(s)
physical exercise
Intervention Description
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 Outcome Measure Information:
Title
cognitive function as measured by neuropsychological tests
Description
neuropsychological test battery will be administered to patients at baseline and immediately after the intervention at 6 months
Time Frame
6 months after the initial assessment
Secondary Outcome Measure Information:
Title
Objective measures of physical fitness measured by cardiopulmonary exercise test (CPET)
Description
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
Time Frame
6 months after the initial assessment
Other Pre-specified Outcome Measures:
Title
Patient reported outcome measured with self-reported questionnaires
Description
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)
Time Frame
6 months after the initial assessment
Title
Subjective cognition measured with Cognitive Functioning Scale (CFS) and Cognitive Failures Questionnaire (CFQ)
Description
Subjective cognition is measured with self-reported questionaire at baseline and after intervention at 6 months
Time Frame
6 months after the initial assessment
Title
Mental well-being measured with self-reported questionnaires
Description
Mental well-being is measured with specific questionaire at baseline and after intervention at 6 months
Time Frame
6 months after the initial assessment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Gehring, PhD
Organizational Affiliation
Tilburg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tilburg University
City
Tilburg
State/Province
Nood-Brabant
ZIP/Postal Code
5037 AB
Country
Netherlands
12. IPD Sharing Statement
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Effects of Exercise on Cognitive Function in Glioma Patients
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