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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Medical University

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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals diagnosed with lung cancer by a physician.

Aged 20 years or older.

Education level of elementary school graduation or above.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: continuous exercise groupExperimental treatment 1 intervention
Group C: low-intensity exercise groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

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