A Pilot Randomized Controlled Trial on the Feasibility and Efficacy of an Exercise Intervention to Improve Cognitive Functioning in Patients With Glioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- cognitive function as measured by neuropsychological tests
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
cognitive function as measured by neuropsychological tests
时间窗: 6 months after the initial assessment
neuropsychological test battery will be administered to patients at baseline and immediately after the intervention at 6 months
次要结局
- Objective measures of physical fitness measured by cardiopulmonary exercise test (CPET)(6 months after the initial assessment)
研究者
Karin Gehring
Phd
Tilburg University