NCT00620932撤回不适用
Feasibility of Endurance Exercise Training on Cardiovascular Risk Factors Following Radical Prostatectomy Among Men With Localized Prostate Cancer; A Community-Based Intervention
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring.
研究概览
简要总结
The primary objective is to determine the feasibility and acceptability of a home-based endurance exercise program among men diagnosed with clinically localized prostate cancer.
详细描述
Approximately 40 people will take part in this study and all of these people will take part at Duke University Medical Center.
Participation in this study involves the following.
- We will ask you to perform a cardiopulmonary exercise test (walking stress test) to determine if you have any undiagnosed cardiovascular health problems that may limit your ability to participate in an exercise training program. This test will take place at the Duke Center for Living on Duke University Campus.
- Complete a body composition assessment. This test is designed to determine your body fat and lean body tissue (muscle mass) percentage and will consist of you sitting quietly in a chamber with appropriate medical supervision. This test also will take place at the Duke Center for Living on Duke University Campus.
- Complete two questionnaires one at the beginning and one at the end that asks about how you are feeling and about your physical activity levels. The questionnaire takes about 20-30 minutes.
- Provide two blood samples one at the beginning and one at the end to measure levels of cardiovascular disease risk factors (cholesterol levels, c-reactive protein and insulin levels) in your blood that may be influenced by exercise. Blood collection will be drawn by medical staff at Duke University. The amount of blood drawn is approximately 2 teaspoons (10ml).
- We will also collect information on how much treatment you receive as well as how many and what type of side-effects you have from your medical treatment. This information will be obtained from your medical chart following the completion of your treatment.
Following the successful completion of all initial tests and procedures (as described above), you will be randomly assigned (like flipping a coin) to one of the following two groups:
- Exercise Training Group: You will be given a customized training program aimed at increasing cardiorespiratory fitness. You will be asked to exercise 3 to 5 times per week. All sessions will include a 5 minute warm-up and 5 minute cool-down at the beginning and end of each session totaling 30-45 minutes per session. You will also receive a heart rate monitor to record each exercise session to monitor adherence and compliance. You will receive telephone calls every two weeks to provide encouragement, outline goals, and provide feedback on study progress.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Legal age (>18 years old)
- •An interval of at least 6 weeks between prior radical prostatectomy and study enrollment
- •Karnofsky performance status of at least 70% at study entry
- •Estimated life expectancy of ≥6 months
- •Ability to read and understand English
- •Attending urologist approval
- •Signed informed consent
- •Willingness to be randomized; and
- •No contraindications to exercise as recommended by the American Thoracic Society
排除标准
- •Acute myocardial infarction (6 weeks)
- •Unstable angina
- •Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- •Acute endocarditis
- •Acute myocarditis or pericarditis
- •Uncontrolled heart failure
- •Acute pulmonary embolus or pulmonary infarction
- •Thrombosis of lower extremities
- •Suspected dissecting aneurysm
- •Uncontrolled asthma
- •Pulmonary edema
- •Room air desaturation at rest ≤85%
- •Respiratory failure
- •Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise; and
- •Mental impairment leading to inability to cooperate
结局指标
主要结局
Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring.
时间窗: 6 months
次要结局
- Fasting lipids will be assessed.(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
mHealth Technology in People With Parkinson's DiseaseParkinson DiseaseNCT05829915Universidad Rey Juan Carlos114
招募中
不适用
Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Lateral Hip PainGreater Trochanteric Pain SyndromeNCT06456099Aalborg University20
尚未招募
不适用
Feasibility of home-based exercise with tablet and sensor: pilot studyFrailtyNL-OMON22191niversity Medical Center GroningenRijksUniversiteit Groningen50
终止
不适用
Adapted Physical Activity for Breast Cancer HER2 Positive PatientHER2 Positive Breast CancerNCT02963363Centre Jean Perrin36
Unknown
不适用
Exercise as an Intervention in Endometrial Cancer SurvivorsEndometrial CancerQuality of LifeNCT02367950Royal Cornwall Hospitals Trust50
