Pre-Habilitation Exercise Intervention for Patients Scheduled for Colorectal Surgical Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- The primary outcome measure for this study is fatigue assessed by the FACIT-F fatigue subscale..
研究概览
简要总结
The purpose of this study is to see whether exercise can improve the health and well-being of patients scheduled to undergo surgery for a bowel related condition.
详细描述
The proposed randomized controlled trial aims to recruit 60 patients that have a primary diagnosis of either colon or rectal cancer, inflammatory bowl disease, or diverticular disease and are scheduled for elective surgery. This two-arm clinical trial of an intervention examining the efficacy of a home-based walking and progressive resistance exercise program for the relief of post-operative fatigue and improvement of functional outcome following surgery.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a primary diagnosis of one of the following: colon or rectal cancer, inflammatory bowel disease, or diverticular disease
- •Be scheduled for elective (non- emergent) surgery
- •Have the approval of their treating physician, study physician, or physician's designee to participate in maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program.
- •Be able to read English (since the assessment materials will be in a printed format).
- •Be 18 years of age or older
- •Give informed consent.
排除标准
- •Have physical limitations (e.g. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the Par-Q+ and clinician (or physician's designee)
- •Must not be in active or maintenance stage of exercise
结局指标
主要结局
The primary outcome measure for this study is fatigue assessed by the FACIT-F fatigue subscale..
时间窗: 12 weeks
The primary analyses will involve examination of means, standard deviations, and effect sizes of the two arms on fatigue at all three times, separately by cohort and combined.
次要结局
- Aerobic Capacity via VO2 maximum testing(12 weeks)
- Circulating Levels of Pro-Inflammatory Cytokines will be measured by standard Complete Blood Count (CBC) differential procedures.(12 weeks)
- Post-operative Complications will be extracted from patient charts and will be classified for severity using the Clavien-Dindo classification of surgical complications.(12 weeks)
- Skeletal Muscle Mass will be assessed using bio-electrical impedance assessment of muscle mass(12 weeks)
- Skeletal Muscle Mass will be assessed using CT assessment of muscle mass(12 weeks)
- Quality of Life (QOL) on self reported psychological distress questionnaires: Profile of Mood States (POMS).(12 weeks)
- Quality of Life (QOL) on self reported psychological distress questionnaires: Spielberg State/Trait Anxiety Inventory (STAI Form Y-1).(12 weeks)
研究者
Fergal Fleming
Assistant Professor
University of Rochester