A Program for the Development and Dissemination of Exercise Prescription and Intervention for Cancer Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Dominant Handgrip Strength Test
研究概览
简要总结
The purpose of this study is to establish a safe and systematic exercise assessment and prescription program for cancer survivors. It can be challenging for cancer patients to start exercising due to various health risks, so this study aims to create a personalized and easily reproducible workflow. The study will include cancer patients who have completed their primary curative treatments at least 2 months ago.
Participants will undergo a comprehensive health and fitness evaluation led by a study physician. This evaluation includes:
- A review of medical history and cardiovascular risk.
- Functional physical fitness tests.
- Cardiopulmonary Exercise Testing (CPET) to carefully evaluate heart and lung function during physical exertion.
- A musculoskeletal ultrasound, if deemed necessary. Based on these combined results, the medical team will determine each participant's exercise risk level and design a personalized exercise prescription. Participants will then be assigned to an appropriate and safe exercise setting.
To ensure safety and maximize health benefits, the study includes a continuous tracking system. Participants will report their exercise progress every 4 weeks and undergo a full reassessment every 3 months. The medical team will use this feedback to safely adjust the participant's risk level and exercise prescription over time.
详细描述
This study is designed as a single-arm, open-label interventional research project. The primary objective is to establish and implement a systematic, institution-based exercise prescription protocol tailored for cancer survivors.
The clinical pathway initiates with patient referral and preliminary screening conducted by collaborating physicians or case managers. Eligible participants then undergo a physiatrist-led, multi-faceted pre-exercise evaluation. This comprehensive assessment integrates a medical history review, cardiovascular risk profiling, functional physical fitness testing, and Cardiopulmonary Exercise Testing (CPET). Additionally, musculoskeletal ultrasound examinations are performed when deemed clinically necessary to objectively evaluate the participant's physical condition.
Based on the integrated assessment results, physiatrists stratify participants into high, moderate, or low exercise risk categories. Individualized exercise prescriptions are then formulated according to the assigned risk level, detailing the required exercise modalities-including aerobic exercise, resistance training, and flexibility exercises-as well as the specific intensity, frequency, duration, and safety precautions.
During the implementation phase, participants execute the prescribed exercise program while utilizing standardized weekly training logs to record their progress. The protocol incorporates an adverse event reporting and data feedback mechanism to ensure continuous safety monitoring and intervention quality. To maintain a dynamic care model, clinical data collection and comprehensive reassessments occur at three distinct time points: baseline (T0), the third month of the intervention (T1), and the sixth month of the intervention (T2). These periodic three-month re-evaluations facilitate the continuous adjustment of both the risk stratification and the personalized exercise prescription, ensuring the intervention remains safe, accurate, and effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years.
- •Cancer Cohorts: Pathologically confirmed diagnosis of AJCC TNM stage I-III, and having completed curative-intent treatment (including surgery ± adjuvant chemotherapy/radiotherapy, etc) for at least 2 months.
- •Cancer cohort must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-
- •Ability to comply with weekly structured exercise training (3-4 professionally supervised sessions per week) and willingness to accept telephone follow-ups or report exercise status via exercise logs/wearable devices.
- •Self-reported failure to meet the following physical activity guidelines within the past 3 months: at least 150 minutes of moderate-intensity aerobic exercise per week OR at least 75 minutes of vigorous-intensity aerobic exercise per week; AND no regular resistance training (≥ 2 sessions per week) within the past 3 months.
排除标准
- •Cardiovascular instability: History of acute coronary syndrome (ACS), myocardial infarction (MI), acute exacerbation of heart failure, or hospitalization for heart failure within the past 3 months; unstable angina; uncontrolled arrhythmia; or uncontrolled hypertension (resting blood pressure > 180/110 mmHg).
- •Hypoxemia: Resting oxygen saturation (SpO2) < 90%.
- •Metabolic instability: Severe hypoglycemic event or diabetic ketoacidosis (DKA) within the past 3 months.
- •Musculoskeletal or neurological risks: Unstable bone metastasis or bone metastasis with a high risk of fracture; recent major fracture or orthopedic surgery where weight-bearing is not yet permitted; or other severe neuromuscular diseases that compromise the safety of exercise.
- •Hematological risks: Thrombocytopenia (Platelet count < 50,000/μL), severe anemia (Hemoglobin [Hb] < 8 g/dL), or neutropenia (Absolute Neutrophil Count [ANC] < 1,000/μL).
- •Deemed unsuitable for exercise intervention as determined by clinical assessment from the attending physician or study investigator.
- •Concurrent participation in other formal exercise or weight-loss intervention programs.
- •Inability to comprehend or complete the informed consent form, or inability to comply with the study procedures.
研究组 & 干预措施
Experimental group
structured exercise intervention group
干预措施: structured exercise training (Other)
结局指标
主要结局
Dominant Handgrip Strength Test
时间窗: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
The participant is evaluated in a seated or standing position with the shoulder adducted, the elbow flexed at approximately 90 degrees, and the forearm and wrist in a neutral position. Using a calibrated handgrip dynamometer, the participant performs a maximal voluntary contraction (MVC) with the dominant hand for approximately 3 seconds. The test is repeated 3 times with at least a 30-second rest interval between trials. The highest value obtained from the three trials is recorded as the final result.
30-Second Arm Curl Test
时间窗: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
The participant sits in a chair with their back straight and feet flat on the floor, holding a standard dumbbell in the dominant hand (8 lbs / 3.63 kg for males; 5 lbs / 2.27 kg for females). The participant performs repeated full elbow flexion and extension movements over a 30-second period while maintaining shoulder stability. The total number of correctly completed repetitions within the full range of motion is recorded.
30-Second Chair Stand Test
时间窗: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
Using a standard-height chair without armrests, the participant sits with arms crossed over the chest and their back resting against the backrest. Upon the start signal, the participant repeatedly rises to a full standing position and returns to a fully seated position within a 30-second timeframe. The total number of completed stands is recorded.
Single-Leg Stance Test
时间窗: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
The participant places both hands on their hips and stands on the dominant leg with the contralateral leg lifted off the floor. Timing commences with the participant's eyes open and focused straight ahead, and ceases when any of the following compensatory movements occur: the arms are moved from the hips, the lifted leg moves (toward or away from the stance leg, or touches the floor), the stance foot shifts or lifts, or a loss of balance is observed. The test is repeated 3 times with at least a 30-second rest interval between trials. The average duration of the three trials is recorded as the final result.
6-Minute Walk Distance
时间窗: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
This outcome measures the maximal distance a participant can travel in 6 minutes on a hard, flat surface. The total distance is recorded in meters (m). Higher values indicate better cardiopulmonary endurance and functional mobility.
Peak Oxygen Consumption (Peak VO2)
时间窗: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
Peak oxygen consumption (Peak VO2) is determined through Cardiopulmonary Exercise Testing (CPET). It represents the highest rate of oxygen uptake achieved by the participant during the exercise test. The results are measured and reported in milliliters per kilogram per minute (mL/kg/min).
Peak Work Rate
时间窗: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
Peak work rate is determined through a symptom-limited Cardiopulmonary Exercise Testing (CPET) using a progressive, incremental ramp protocol on a stationary cycle ergometer. It represents the maximum mechanical power output that the participant can achieve and sustain immediately prior to reaching volitional exhaustion or clinical symptom limitation. The result is measured and reported in Watts (W).
次要结局
- Short Form-36 (SF-36)(Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2))
- Functional Assessment of Cancer Therapy-General (FACT-G)(Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2))
- Brief Fatigue Inventory (BFI)(Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2))