An interventional study of Low-Intensity Continuous Endurance Exercise Training and Low-Intensity Interval Endurance Exercise Training in Lung Cancer (Diagnosis), sponsored by Taipei Medical University. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care
To conduct a randomized controlled trial (RCT) targeting lung cancer patients with cancer-related fatigue to achieve the following objectives:
Objective 1: To investigate whether a low-intensity endurance exercise intervention can effectively improve mitochondrial DNA content, mitochondrial function, mitochondrial oxidative phosphorylation complex enzyme concentrations, cellular bioelectrical impedance phase angle, cancer-related fatigue, and quality of life in lung cancer patients with cancer-related fatigue.
Objective 2: To explore whether the low-intensity endurance exercise intervention improves cancer-related fatigue and quality of life in lung cancer patients through direct or indirect effects by modulating mitochondrial DNA content, mitochondrial function, mitochondrial oxidative phosphorylation complex enzyme concentrations, and cellular bioelectrical impedance phase angle.
Objective 3: To investigate the correlation between personality traits and adherence to low-intensity endurance exercise in lung cancer patients.
Objective 4: To investigate whether a low-intensity endurance exercise intervention can effectively improve sleep quality in lung cancer patients with cancer-related fatigue.
Objective 5: To investigate whether a low-intensity endurance exercise intervention can effectively reduce stress in lung cancer patients with cancer-related fatigue.
After enrollment, participants will be randomly assigned to one of the following three groups:
Low-Intensity Continuous Endurance Exercise Training Group (Level 2) Participants will perform Level 2 low-intensity continuous endurance exercise for at least 30 consecutive minutes per day, 5 days per week. Exercise intensity will be maintained at 75-80% of peak heart rate (HRpeak), corresponding to a Rating of Perceived Exertion (RPE) of 11-12 (light). At this intensity, participants should perceive the exercise as relatively easy, with an increased breathing rate but still be able to carry on a conversation comfortably, although occasional pauses for breathing may be required.
Each exercise session will consist of:
Participants will perform 30 minutes of interval endurance exercise per day, 5 days per week. Each session will consist of five alternating cycles, with each cycle including:
Each exercise session will begin with a 5-minute warm-up and conclude with a 10-minute cool-down, during which exercise intensity will be gradually reduced until exercise cessation.
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Exclusion Criteria:
Participants assigned to the control group will not receive any exercise intervention and will be instructed to maintain their usual daily lifestyle and physical activity throughout the study period.
Participants will perform Level 2 low-intensity continuous endurance exercise for at least 30 consecutive minutes per day, 5 days per week. Exercise intensity will be maintained at 75-80% of peak heart rate (HRpeak), corresponding to a Rating of Perceived Exertion (RPE) of 11-12 (light). Each exercise session will consist of a 5-minute warm-up, 30 minutes of continuous low-intensity endurance exercise, and a 10-minute cool-down.
Behavioral: Low-Intensity Continuous Endurance Exercise Training
Participants will perform 30 minutes of interval endurance exercise per day, 5 days per week. Each session will consist of five alternating cycles, with each cycle including 3 minutes of Level 2 low-intensity endurance exercise at 75-80% HRpeak (RPE 11-12), followed by 3 minutes of Level 1 very low-intensity endurance exercise at 65-75% HRpeak (RPE \<11). Each exercise session will begin with a 5-minute warm-up and conclude with a 10-minute cool-down.
Behavioral: Low-Intensity Interval Endurance Exercise Training
Participants will perform Level 2 low-intensity continuous endurance exercise for at least 30 consecutive minutes per day, 5 days per week. Intensity at 75-80% HRpeak (RPE 11-12).
Participants will perform 30 minutes of interval endurance exercise per day, 5 days per week. Five alternating cycles (3 mins Level 2 at 75-80% HRpeak + 3 mins Level 1 at 65-75% HRpeak).
Change from baseline in Cancer-Related Fatigue (CRF)
Evaluated by the Brief Fatigue Inventory-Taiwan (BFI-T) and the ICD-10 diagnostic criteria for cancer-related fatigue. The BFI-T total score ranges from 0 to 90, with higher scores indicating greater fatigue severity and interference with daily life.
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from baseline in leukocyte mitochondrial DNA copy number and mitochondrial function
Leukocyte mitochondrial DNA (mtDNA) copy number will be quantified using real-time quantitative PCR (qPCR) by calculating the relative mtDNA-to-nuclear DNA ratio. Mitochondrial function will be evaluated by measuring the oxygen consumption rate (OCR) and ATP coupling efficiency using the Seahorse XFp extracellular flux analyzer.
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Cellular Bioelectrical Impedance Phase Angle and Skeletal Muscle Mass
Measured by the InBody S10 multi-frequency bioelectrical impedance analyzer. Higher phase angle values indicate better cellular integrity and cell function.
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Quality of Life (QoL)
Evaluated using the Functional Assessment of Cancer Therapy-General (FACT-G) Taiwan version. The total score ranges from 0 to 108, with higher scores representing better health-related quality of life.
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Sleep Quality
Assessed by the Pittsburgh Sleep Quality Index (PSQI) Taiwan form. Total scores range from 0 to 21, where a score \> 5 indicates poor sleep quality.
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Perceived Stress
Measured by the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Predictors of Exercise Adherence (Personality Traits)
Evaluated using the International English Big-Five Mini-Markers (Chinese version) at baseline to explore its correlation with the 12-week low-intensity endurance exercise adherence rate.
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Plan to share: Undecided
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