A Pilot Study to Investigate the Effects of Combining a Modified Atkins Diet With a Physical Fitness Regimen in Patients Diagnosed With Malignant Glioma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Short Form (SF)-36 Version 2 Score
研究概览
简要总结
This is a pilot study assessing the effects of combining a modified Atkins diet with a physical fitness regimen in patients with malignant glioma. A sample size of 15 participants will be enrolled in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tissue confirmed diagnosis of high-grade glioma (World Health Organization grade III or IV)
- •Karnofsky Performance Status (KPS) ≥ 70%
- •Willing to follow the study intervention and follow-up
- •Able to give full informed consent
排除标准
- •Currently undergoing initial concurrent radiation/chemotherapy
- •Severe medical co-morbidities
- •Any medical condition which prohibits moderate to vigorous physical activity (60-85% HRmax)
- •Any medical condition which prohibits a restrictive diet
- •Neurological deficit preventing participation in moderate to vigorous physical activity
- •Severe psychiatric illness
研究组 & 干预措施
Patients Diagnosed with Malignant Glioma
Patients will participate in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.
干预措施: Fitness Program (Behavioral)
Patients Diagnosed with Malignant Glioma
Patients will participate in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.
干预措施: Modified Atkins Diet (Behavioral)
结局指标
主要结局
Change in Short Form (SF)-36 Version 2 Score
时间窗: Baseline, Week 12
The SF-36
Number of Participants who Complete Full 12-Week Program
时间窗: Week 12
次要结局
- Change in 1 Repetition Maximum (1RM) - Leg Press(Baseline, Week 12)
- Change in Blood Ketone Levels(Baseline, Week 12)
- Change in Resting Heart Rate(Baseline, Week 12)
- Change in 400-meter Walk Time(Baseline, Week 12)
- Change in 1 Repetition Maximum (1RM) - Chest Press(Baseline, Week 12)
- Change in Satisfaction With Life Scale (SWLS) Score(Baseline, Week 12)
- Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score(Baseline, Week 12)
- Change in Hospital Anxiety And Depression Scale (HADS) Score(Baseline, Week 12)
- Change in Fatigue Severity Scale (FSS) Score(Baseline, Week 12)