Development and Dissemination of Exercise Prescription and Intervention for Cancer Populations
A Program for the Development and Dissemination of Exercise Prescription and Intervention for Cancer Populations
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ko-Long Lin, PhD
- 電話番号：886-978-862-831
- メール：klin967@gmail.com
研究場所
-
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Taiwan
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Kaohsiung、Taiwan、台湾、807
- 募集
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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コンタクト：
- Ko-Long Lin, PhD
- 電話番号：886-978-862-831
- メール：klin967@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Experimental group
structured exercise intervention group
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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:
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dominant Handgrip Strength Test
時間枠：Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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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.
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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30-Second Arm Curl Test
時間枠：Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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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.
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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30-Second Chair Stand Test
時間枠：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.
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
|
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Single-Leg Stance Test
時間枠：Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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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.
|
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
|
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6-Minute Walk Distance
時間枠：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.
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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Peak Oxygen Consumption (Peak VO2)
時間枠：Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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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).
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
|
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Peak Work Rate
時間枠：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).
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Short Form-36 (SF-36)
時間枠：Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
|
The SF-36 is a 36-item patient-reported questionnaire that measures health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Each domain is scored on a scale from 0 to 100.
Higher scores indicate a more favorable health state and better quality of life.
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
|
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Functional Assessment of Cancer Therapy-General (FACT-G)
時間枠：Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
|
The FACT-G is a 27-item questionnaire designed to measure health-related quality of life in patients receiving cancer therapy.
It assesses four primary domains: Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items).
Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The subscale scores are summed to yield a total score ranging from 0 to 108, with higher scores representing a better quality of life and lower symptom burden.
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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Brief Fatigue Inventory (BFI)
時間枠：Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
|
The BFI is a 9-item questionnaire used to rapidly assess the severity of fatigue and its impact on daily functioning, particularly in cancer patients.
Patients rate their fatigue severity (at its "worst," "usual," and "now" over the past 24 hours) and the extent to which fatigue interferes with six domains of daily life (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life).
All items are scored on an 11-point numeric rating scale from 0 (no fatigue / does not interfere) to 10 (as bad as you can imagine / completely interferes).
A global fatigue score is calculated as the mean of all answered items, ranging from 0 to 10, with higher scores indicating more severe fatigue and greater interference with daily life.
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Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KMUHIRB-F(I)-20260064
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