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

NCT07795580 | Recruiting

• 1 other identifier: N20261110
• Study Type: interventional
• Target: 450
• 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. 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.

Conditions

Lung Cancer (Diagnosis)

Keywords

Low-Intensity Endurance Exercise; Cancer-Related Fatigue (CRF)

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, Week 6, Week 12, and monthly up to 15 months.

Secondary Outcomes (3)

• Change from Baseline in Sleep Quality

  Baseline, Week 6, Week 12, and monthly up to 15 months.

• Change from Baseline in Perceived Stress

  Baseline, Week 6, Week 12, and monthly up to 15 months.

• Predictors of Exercise Adherence (Personality Traits)

  Baseline, Week 6, Week 12, and monthly up to 15 months.

Study Arms (3)

Control Group

NO INTERVENTION

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.

continuous exercise group

EXPERIMENTAL

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

low-intensity exercise group

EXPERIMENTAL

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

Interventions

Low-Intensity Continuous Endurance Exercise Training BEHAVIORAL

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).

continuous exercise group

Low-Intensity Interval Endurance Exercise Training BEHAVIORAL

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).

low-intensity exercise group

Eligibility Criteria

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

You may qualify if:

• Individuals diagnosed with lung cancer by a physician.
• Aged 20 years or older.
• Education level of elementary school graduation or above.

You may not qualify if:

• Individuals who are unable to communicate in Mandarin Chinese, Taiwanese, or Hakka.
• Individuals whose physical condition is determined by a physician to be unsuitable for performing any exercise.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, 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: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors who perform blood sampling and bioelectrical impedance analysis are blinded to the group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a two-phase project. Phase 1 applies a cross-sectional observational design to explore the correlations among mitochondrial functions, bioelectrical impedance phase angle, personality traits, and cancer-related fatigue in 450 lung cancer patients. Phase 2 is a randomized controlled trial (RCT) involving 3 parallel arms: (1) a control group, (2) a low-intensity endurance continuous exercise training group, and (3) a low-intensity endurance interval exercise training group, to evaluate the effects of a 12-week exercise intervention.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

TW (1)