The Effects of Low Intensity Endurance Exercise on Improving Mitochondrial Function, Cell Bioelectrical Impedance Phase Angle, Fatigue and Quality of Life in Lung Cancer Patients With Cancer-related Fatigue

NCT07806682 | Recruiting

• 1 other identifier: N202404024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (Diagnosis)

Keywords

Cancer-Related Fatigue; Endurance Exercise; Mitochondrial Function; Bioelectrical Impedance Phase Angle; Quality of Life; Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline, Week 6, and Week 12

• 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

  Baseline, Week 6, and Week 12

• 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

  Baseline, Week 6, and Week 12

• 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).

  Baseline, Week 6, and Week 12

Study Arms (3)

Control Group

NO INTERVENTION

No exercise intervention will be implemented, and participants will carry out their daily activities according to their previous lifestyle habits.

Continuous Training Group

EXPERIMENTAL

Level 2 low-intensity continuous endurance exercise: Participants will perform Level 2 low-intensity endurance exercise training continuously for at least 30 minutes per day, at least 5 days per week, for 12 consecutive weeks. The exercise intensity will be 75-80% of peak heart rate, with a rating of perceived exertion of 11-12. At this intensity, participants will perceive the exercise as easy, but their breathing sound will increase; they will be able to converse comfortably during exercise but may occasionally need to pause for breath

Behavioral: Low-Intensity Endurance Continuous Exercise

Intermittent Training Group

EXPERIMENTAL

Participants will perform alternating training consisting of 3 minutes of Level 2 low-intensity endurance exercise and 3 minutes of Level 1 minimal-intensity endurance exercise, for a total of 5 alternating cycles. The training will be performed continuously for at least 30 minutes per day, at least 5 days per week, for 12 consecutive weeks. Level 1 exercise intensity will be 65-75% of peak heart rate, with a rating of perceived exertion below 11, indicating that participants perceive the exercise as very easy.

Behavioral: Low-Intensity Endurance Interval Exercise

Interventions

Low-Intensity Endurance Interval Exercise BEHAVIORAL

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.

Intermittent Training Group

Low-Intensity Endurance Continuous Exercise BEHAVIORAL

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.

Continuous Training Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hsiu Ting Tsai, PhD

CONTACT

886227361661; hsiuting@tmu.edu.tw

Hsin-Hui Huang, Master's degree

CONTACT

886227361661; d432113014@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 8, 2026
• Study Start: March 10, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-08

Locations

TW (1)