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Development and Dissemination of Exercise Prescription and Intervention for Cancer Populations

3 agosto 2026 aggiornato da: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Ko-Long Lin, PhD
  • Numero di telefono: 886-978-862-831
  • Email: klin967@gmail.com

Luoghi di studio

  • Taiwan
    • Taiwan
      • Kaohsiung, Taiwan, Taiwan, 807
        • Reclutamento
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Aged 18 to 80 years.
  2. 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.
  3. Cancer cohort must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
  4. 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.
  5. 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:

  1. 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).
  2. Hypoxemia: Resting oxygen saturation (SpO2) < 90%.
  3. Metabolic instability: Severe hypoglycemic event or diabetic ketoacidosis (DKA) within the past 3 months.
  4. 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.
  5. Hematological risks: Thrombocytopenia (Platelet count < 50,000/μL), severe anemia (Hemoglobin [Hb] < 8 g/dL), or neutropenia (Absolute Neutrophil Count [ANC] < 1,000/μL).
  6. Deemed unsuitable for exercise intervention as determined by clinical assessment from the attending physician or study investigator.
  7. Concurrent participation in other formal exercise or weight-loss intervention programs.
  8. Inability to comprehend or complete the informed consent form, or inability to comply with the study procedures.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental group
structured exercise intervention group
Altro: 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).
  • Resistance Training: 2-3 days/week (48h rest per muscle group) at 60-80% 1-RM or a load for 6-15 reps. Employs progressive overload without requiring muscular failure. Involves 8-10 major muscle groups; ≥1 set/exercise, ≥6 reps/set, with ≥60s rest between sets. Modalities adapt to patient status.
  • Flexibility Training: ≥2-3 days/week (up to daily). Static stretches (10-30s hold, 2-4 reps, stretching to mild discomfort but avoiding pain) covering all major muscles.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dominant Handgrip Strength Test
Lasso di tempo: 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.
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
30-Second Arm Curl Test
Lasso di tempo: 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.
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
30-Second Chair Stand Test
Lasso di tempo: 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.
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
Single-Leg Stance Test
Lasso di tempo: 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.
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
6-Minute Walk Distance
Lasso di tempo: 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.
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
Peak Oxygen Consumption (Peak VO2)
Lasso di tempo: 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).
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
Peak Work Rate
Lasso di tempo: 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).
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Short Form-36 (SF-36)
Lasso di tempo: 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.
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
Functional Assessment of Cancer Therapy-General (FACT-G)
Lasso di tempo: 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.
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)
Brief Fatigue Inventory (BFI)
Lasso di tempo: 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.
Pre-intervention (T0), after 3 months of intervention (T1), and 6 months after intervention (T2)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 marzo 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

3 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 agosto 2026

Primo Inserito (Effettivo)

7 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 agosto 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KMUHIRB-F(I)-20260064

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

There is no plan to share individual participant data (IPD) in order to maintain participant privacy and confidentiality

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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