Development and Dissemination of Exercise Prescription and Intervention for Cancer Populations

NCT07751783 | Recruiting

• 1 other identifier: KMUHIRB-F(I)-20260064
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Survivor; Cancer; Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma); Lung Cancer (Non-Small Cell); Liver Cancer, Adult

Keywords

exercise; Cardiopulmonary Exercise Testing; cancer; Exercise prescription; Aerobic exercise; resistance exercise

Outcome Measures

Primary Outcomes (7)

• Dominant Handgrip Strength Test

  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

  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

  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

  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

  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)

  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

  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)

Secondary Outcomes (3)

• 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)

Study Arms (1)

Experimental group

EXPERIMENTAL

structured exercise intervention group

Other: structured exercise training

Interventions

structured exercise training OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms; Breast Neoplasms; Lymphoma; Multiple Myeloma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Hepatocellular; Motor Activity

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Liver Neoplasms; Liver Diseases; Behavior

Central Study Contacts

Ko-Long Lin, PhD

CONTACT

886-978-862-831; klin967@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)