Lung Cancer (Diagnosis)
Conditions
Keywords
Cancer-Related Fatigue, Endurance Exercise, Mitochondrial Function, Bioelectrical Impedance Phase Angle, Quality of Life, Lung Cancer
Brief summary
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.
Detailed description
After enrollment, subjects will be randomly assigned to three groups: 1. Control Group: No exercise intervention will be implemented. Subjects will maintain their usual lifestyle and daily activities. 2. Low-Intensity Endurance Continuous Training Group (Level 2 low-intensity continuous endurance exercise): Subjects will perform Level 2 low-intensity endurance exercise training for at least 30 continuous minutes per day, at least 5 days per week (75-80% peak heart rate \[HR peak\], Rating of Perceived Exertion \[RPE\] 11-12; the exerciser perceives the exertion as light, but breathing sounds increase, and they can comfortably hold a conversation during exercise but need to pause occasionally for breath). This continuous low-intensity endurance training will last for 12 consecutive weeks. Each exercise session will begin with a 5-minute warm-up, followed by 30 minutes of continuous low-intensity endurance exercise, and conclude with a gradual 10-minute cool-down until completely stopping. 3. Low-Intensity Endurance Interval Training Group (Alternating 3 minutes of Level 2 low-intensity endurance exercise and 3 minutes of Level 1 lowest-intensity endurance exercise, for a total of 5 alternating cycles): Subjects will perform alternating Level 2 and Level 1 (65-75% HR peak, RPE \<11; the exerciser perceives the exertion as very light) exercise training for at least 30 continuous minutes per day, at least 5 days per week. This low-intensity endurance interval training will last for 12 consecutive weeks. Each exercise session will begin with a 5-minute warm-up, followed by 30 minutes of low-intensity endurance interval training, and conclude with a gradual 10-minute cool-down until completely stopping.
Interventions
BEHAVIORALLow-Intensity Endurance Continuous Exercise
Participants 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.
BEHAVIORALLow-Intensity Endurance Interval Exercise
Participants 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.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Intervention model description
A randomized controlled trial with 3 parallel groups: (1) Control group: maintaining usual lifestyle; (2) Continuous training group: low-intensity endurance continuous exercise for 30 mins, 5 days/week for 12 weeks; (3) Intermittent training group: low-intensity endurance intermittent exercise (alternating level 2 and level 1 intensity) for 30 mins, 5 days/week for 12 weeks.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are diagnosed with lung cancer by a physician ; 2. Patients aged 20-70 years; 3. Patients who are determined by a physician, after assessment of their physical condition, to be suitable for exercise; 4. Patients who have graduated from elementary school or above.
Exclusion criteria
1. Patients who are unable to communicate in Mandarin, Taiwanese, or Hakka; 2. Patients who are determined by a physician to be physically unsuitable for performing any exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mitochondrial oxidative phosphorylation complex enzyme concentrations | Baseline, Week 6, and Week 12 | 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 Cancer-Related Fatigue (CRF) | Baseline, Week 6, and Week 12 | 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 Quality of Life (QoL) | Baseline, Week 6, and Week 12 | 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 | Baseline, Week 6, and Week 12 | Measured using the InBody S10 bioelectrical impedance analyzer. Phase angle is expressed in degrees (°), and skeletal muscle mass is expressed in kilograms (kg). |
Countries
Taiwan
Contacts
CONTACTHsiu Ting Tsai, PhD
CONTACTHsin-Hui Huang, Master's degree
Outcome results
None listed