Anaplastic Glioma of Brain, Low Grade Glioma of Brain
Conditions
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.
Interventions
BEHAVIORALphysical 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.
Sponsors
Tilburg University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive function as measured by neuropsychological tests | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective measures of physical fitness measured by cardiopulmonary exercise test (CPET) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcome measured with self-reported questionnaires | 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) |
| Subjective cognition measured with Cognitive Functioning Scale (CFS) and Cognitive Failures Questionnaire (CFQ) | 6 months after the initial assessment | Subjective cognition is measured with self-reported questionaire at baseline and after intervention at 6 months |
| Mental well-being measured with self-reported questionnaires | 6 months after the initial assessment | Mental well-being is measured with specific questionaire at baseline and after intervention at 6 months |
Countries
Netherlands
Outcome results
None listed