Development and Dissemination of Exercise Prescription and Intervention for Cancer Populations

Официальное название

A Program for the Development and Dissemination of Exercise Prescription and Intervention for Cancer Populations

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое structured exercise training
  This study utilizes a "Personalized Precision Exercise Training Program." Following baseline Cardiopulmonary Exercise Testing (CPET) and comprehensive fitness assessments, physicians prescribe individualized regimens adhering to ACSM guidelines for cancer survivors, applying the FITT principle: * Aerobic Exercise: 3-5 days/week at moderate intensity, tailored to treatment tolerance. ≥30 mins/session, flexibly adjusted for treatment side effects. Focuses on rhythmic activities (walking, cycling)

Первичные конечные точки

• Dominant Handgrip Strength Test [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]
• 30-Second Arm Curl Test [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]
• 30-Second Chair Stand Test [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]
• Single-Leg Stance Test [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]
• 6-Minute Walk Distance [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]
• Peak Oxygen Consumption (Peak VO2) [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]
• Peak Work Rate [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]

Вторичные конечные точки (3)

• Short Form-36 (SF-36) [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]
• Functional Assessment of Cancer Therapy-General (FACT-G) [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]
• Brief Fatigue Inventory (BFI) [Срок оценки: Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)]

Критерии участия

Критерии включения

• 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 0-2.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung

Идентификаторы

NCT: NCT07751783 · KMUHIRB-F(I)-20260064

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗