Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Location status: Recruiting
NCT Number: NCT07751783
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Kaohsiung, Taiwan, 807
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Other
A Program for the Development and Dissemination of Exercise Prescription and Intervention for Cancer Populations
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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