A pilot randomized controlled trial on the feasibility and efficacy of an exercise intervention to improve cognitive functioning in patients with glioma
- Conditions
- cognitieve stoornissengliomabrain tumour10029211
- Registration Number
- NL-OMON40500
- Lead Sponsor
- niversiteit van Tilburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
Adult patients with supratentorial glioma, in particular:
(1a) histologically proven low-grade glioma (LGG; astrocytoma, oligodendroglioma, oliogo-astrocytoma), or presumed (i.e., suspected) LGG based on both clinical and MR imaging features (>18 years of age < 70); or
(1b) anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oliogo-astrocytoma) under age 50 and with good performance status (KPS > 70),
who:
(2) have been clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MR imaging); and
(3) have had no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids); and
(4) are interested in undergoing a physical exercise program; and
(5) have a relative VO2peak (% predicted based on variables such as age and gender) that leaves room for further improvement of cardiorespiratory fitness.
Potentially eligible patients will be screened for the presence of comorbid conditions that would contraindicate participation in a physical activity/exercise program. This includes patients with serious orthopedic conditions or motor deficits, and patients with serious cardiovascular, cardiopulmonary and neurological conditions (or risks) who would not be able to train at the intensity level required by the programs. Patients judged to have psychiatric (including alcohol and drug abuse) or severe cognitive problems that would preclude them from program participation will be excluded from the study. For assessment purposes, study participants will need to have basic fluency in the Dutch language.
In addition, patients who report to engage in vigorous exercise (>=7 METs (Metabolic equivalents of task)) for more than 20 minutes on at least 3 days per week on a regular basis will be excluded from participation, as there will be no room for further improvement of aerobic fitness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measures will include indicators of feasibility (accrual,<br /><br>adherence, compliance and attrition) and (size of the effect on) performance<br /><br>scores on neuropsychological testing (attention, memory and executive<br /><br>function). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures will include performance measures of physical<br /><br>fitness as measured with CPET (cardiorespiratory exercise testing on a cycle<br /><br>ergometer with ECG and gas exchange measurement), and self-report<br /><br>questionnaires of subjective cognitive functioning, fatigue, sleep, mood and<br /><br>quality of life. </p><br>