NL-OMON40500已完成2 期
A pilot randomized controlled trial on the feasibility and efficacy of an exercise intervention to improve cognitive functioning in patients with glioma - Effects of exercise on cognitive function in glioma patients
niversiteit van Tilburg0 个研究点目标入组 170 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •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),
- •(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.
排除标准
- •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.
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