Effectiveness of a Structured Aerobic Exercise Program in Cancer Survivors - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Feasibility of providing a structured in-person aerobic exercise intervention
研究概览
简要总结
A prospective study of cancer survivor patients enrolling in a pilot aerobic exercise program. The total enrollment will be fifteen patients. The study timeline includes a screening period of 4 weeks, baseline period of 2 weeks, and active study intervention for 12 weeks. Study enrollment will continue until all 15 subjects are enrolled or up to 12 months, whichever comes first.
详细描述
Study Population: Adult cancer survivors within one year of completing cancer-directed therapy.
Study Objective: To determine the feasibility of a prescription exercise program in a cancer survivor population
Specific Objectives:
- Quantify the number of patients who successfully enroll and complete the Program.
- Determine a preliminary benefit, if any, of the program with regard to biometric parameters (change in systolic blood pressure, BMI, body composition, average step count, VO2 max), laboratory parameters (Hgb A1c, CRP, Lipid Profile, IL-6, Apolipoprotein B, Vitamin D-25-OH, Vitamin B12 and Folate), patient-reported wellness surveys (SEE, SRQ, Sleep Surveys).
Study Endpoints/Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adult (>18 yr.) cancer survivor patients who completed treatment within the past year and are able to physically participate in the interventional aerobic exercise program.
排除标准
- •Non-ambulatory individuals
- •Inability to communicate in English
- •Lack of transportation to/from appointments (Of note, language and transportation exclusion criteria are based on practical needs for this pilot study. If effective, services would be open to a broader array of patients).
- •On medications (e.g., Ozempic, Tirzepatide) which induce prolonged weight loss.
- •Patients who received cancer-directed therapy within the past month.
结局指标
主要结局
Feasibility of providing a structured in-person aerobic exercise intervention
时间窗: 6 months
To determine the feasibility of providing a structured in-person aerobic exercise training intervention to cancer survivor patients by determining the percentage of enrolled patients who complete the study.
次要结局
- Weight in Lbs(6 months)
- Percentage total body fat(6 months)
- Waist circumference measurement in cm(6 months)
- Laboratory Assessments of Nutrition, Glucose control and cardiovascular health(6 months)
- Predicted VO2 max in ml/kg/min(6 months)
- Percentage lean body mass(6 months)
- Hip circumference measurement in cm(6 months)
- Blood Pressure in mmHg(6 months)
- Heart Rate in bpm(6 months)
- Body Mass Index (BMI) in Kg/m2(6 months)
- Percentage visceral fat(6 months)
- Neck circumference measurements in cm(6 months)
- Average daily step count(6 months)
研究者
George Miller
Chief of Surgical Oncology
Holy Name Medical Center, Inc.