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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physical exercise | Experimental | Patients will exercise three times per week for 6 months home-based exercise intervention. Session duration will vary between 20 minutes and 45 minutes. |
|
| Active control group | No Intervention | Patients in the active control group will be advised to walk regularly based on brochures from 30minutenbewegen.nl |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months after the initial assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months after the initial assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcome measured with self-reported questionnaires | 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) |
Inclusion Criteria:
Exclusion Criteria:
For assessment purposes, study participants will need to have basic fluency in the Dutch language.
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| Name | Affiliation | Role |
|---|---|---|
| Karin Gehring, PhD | Tilburg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tilburg University | Tilburg | Nood-Brabant | 5037 AB | Netherlands |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 6 months after the initial assessment |
| Subjective cognition measured with Cognitive Functioning Scale (CFS) and Cognitive Failures Questionnaire (CFQ) | 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 | Mental well-being is measured with specific questionaire at baseline and after intervention at 6 months | 6 months after the initial assessment |