About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are diagnosed with lung cancer by a physician ;
Patients aged 20-70 years;
Patients who are determined by a physician, after assessment of their physical condition, to be suitable for exercise;
Patients who have graduated from elementary school or above.
Disqualifiers
Patients who are unable to communicate in Mandarin, Taiwanese, or Hakka;
Patients who are determined by a physician to be physically unsuitable for performing any exercise.
Trial design
Parallel
Treatments tested in this trial
Low-Intensity Endurance Continuous Exercise
BehavioralParticipants perform continuous low-intensity endurance exercise for 30 minutes per day, 5 days per week, for 12 weeks at 75%-80% peak heart rate and RPE 11-12.
Low-Intensity Endurance Interval Exercise
BehavioralParticipants perform alternating low-intensity endurance training consisting of 3-minute Level 2 exercise and 3-minute Level 1 exercise for 30 minutes per day, 5 days per week, for 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in Cancer-Related Fatigue (CRF)
Evaluated by the Brief Fatigue Inventory-Taiwan (BFI-T). The total score ranges from 0 to 90, with higher scores indicating greater fatigue severity and interference with daily life. Higher scores indicate greater fatigue severity.
Change from baseline in mitochondrial oxidative phosphorylation complex enzyme concentrations
Concentrations of mitochondrial complex enzymes (Complex I-V) determined via ELISA at an absorbance wavelength of 600 nm. Expressed in ng/mL
Change from baseline in Quality of Life (QoL)
Evaluated using the Functional Assessment of Cancer Therapy-General; FACT-G. The scale comprises four subscales: (1) Physical Well-Being (PWB): 7 items, score range 0-28; (2) Social/Family Well-Being (SWB): 7 items, score range 0-28; (3) Emotional Well-Being (EWB): 6 items, score range 0-24; and (4) Functional Well-Being (FWB): 7 items, score range 0-28. Higher scores indicate better quality of life
Change from baseline in phase angle and skeletal muscle mass
Measured using the InBody S10 bioelectrical impedance analyzer. Phase angle is expressed in degrees (°), and skeletal muscle mass is expressed in kilograms (kg).
Sponsors and contacts
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