Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Program Evaluation
研究概览
简要总结
The purpose of this study is to determine if individuals with colorectal cancer enjoy yoga and to begin to assess whether yoga is effective in improving attention and immune function in individuals with colorectal cancer compared to physical activity and usual care.
详细描述
The proposed study will use a prospective RCT pilot design with three arms (yoga, resistance and flexibility exercise, usual care) and a total of 60 men and women who have completed therapy (> 6 months post primary or adjuvant therapy) to accomplish the specific aims. Equal numbers of men and women will be randomized into each arm of the study. Participants will be tested before, immediately after, and 3-months after treatment or similar time points for the usual care group. After data has been collected, participants who were randomized to the resistance and flexibility exercise group (active control group) or to the usual care group will be provided with the opportunity to participate in the yoga intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research assistants at Time 2 and 3 are blinded to which arm the participant is in.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a history of any stage new or recuurent colorectal cancer
- •great then 6 months post treatment for colorectal cancer
- •report not fully recovered from the effects of cancer and cancer treatment
- •no clinical signs or symptoms of brain metastasis
- •normal (or corrected to normal) hearing and vision
- •able to read and write English
排除标准
- •conditions that could affect participation in yoga such as spinal disease or unstable joints
研究组 & 干预措施
Yoga
The Yoga Program includes two 90-minute classes every week tor a total of 12 weeks.
干预措施: Yoga (Other)
Physical Activity
The Physical Activity Program includes two 90-minutes classes every week for a total of 12 weeks.The intervention is based on the Exercise for People Living with Cancer program and will include nine resistance exercises (e.g. standing push up, squats, standing leg curl) and 8 flexibility exercises (e.g. shoulder stretch, quadriceps stretch, hamstrings and lower back stretch) targeted for the whole body as well as a brief warm up and cool down (walking).
干预措施: Physical Activity (Other)
Usual Care
Participants randomized to this arm will receive standard care only.
结局指标
主要结局
Program Evaluation
时间窗: At the end of the 12-week yoga and physical activity programs.
The program evaluation was developed by the investigator to measure the participant experience and satisfaction with the interventions.
次要结局
- Digit Span(Change from baseline to 6 months)
- Attention Network Test(Change from baseline to 6 months.)
- Digit Symbol Substitution Test(Change from baseline to 6 months)
- Trail Making Test(Change from baseline to 6 months)
- Attentional Function Index(Change from baseline to 6 months)
- Functional Assessment of Cancer Therapy - Cognitive Function(Change from baseline to 6 months)
- Pro-inflammatory Markers(Change from baseline to 6 months)
研究者
Moira Visovatti
Principal Investigator
University of Michigan