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
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
After enrollment, participants will be randomly assigned to one of the following three groups:
- Control Group 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.
Low-Intensity Continuous Endurance Exercise Training Group (Level 2) 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). At this intensity, participants should perceive the exercise as relatively easy, with an increased breathing rate but still be able to carry on a conversation comfortably, although occasional pauses for breathing may be required.
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, during which exercise intensity will be gradually reduced until cessation.
- Low-Intensity Interval Endurance Exercise Training Group
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, corresponding to an RPE <11 (very light), during which participants should perceive the exercise as very easy.
Each exercise session will begin with a 5-minute warm-up and conclude with a 10-minute cool-down, during which exercise intensity will be gradually reduced until exercise cessation.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Hsiu Ting Tsai, PhD
- Puhelinnumero: 6330 886227361661
- Sähköposti: hsiuting@tmu.edu.tw
Tutki yhteystietojen varmuuskopiointi
- Nimi: Hsin Hui Huang, Master's degree
- Puhelinnumero: 6330 886227361661
- Sähköposti: d432113014@tmu.edu.tw
Opiskelupaikat
-
-
-
Taipei, Taiwan, 110
- Rekrytointi
- Taipei Medical University
-
Ottaa yhteyttä:
- Wen-Chi Liu, MSc
- Puhelinnumero: 1300 02-227372181
- Sähköposti: 116085@tmuh.org.tw
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Individuals diagnosed with lung cancer by a physician.
- Aged 20 years or older.
- Education level of elementary school graduation or above.
Exclusion Criteria:
- 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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Ei väliintuloa: Control Group
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.
|
|
|
Kokeellinen: continuous exercise group
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.
|
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).
|
|
Kokeellinen: low-intensity exercise group
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.
|
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).
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change from baseline in Cancer-Related Fatigue (CRF)
Aikaikkuna: Baseline, Week 6, Week 12, and monthly up to 15 months.
|
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
Aikaikkuna: Baseline, Week 6, Week 12, and monthly up to 15 months.
|
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
Aikaikkuna: Baseline, Week 6, Week 12, and monthly up to 15 months.
|
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)
Aikaikkuna: Baseline, Week 6, Week 12, and monthly up to 15 months.
|
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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change from Baseline in Sleep Quality
Aikaikkuna: Baseline, Week 6, Week 12, and monthly up to 15 months.
|
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.
|
Baseline, Week 6, Week 12, and monthly up to 15 months.
|
|
Change from Baseline in Perceived Stress
Aikaikkuna: Baseline, Week 6, Week 12, and monthly up to 15 months.
|
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.
|
Baseline, Week 6, Week 12, and monthly up to 15 months.
|
|
Predictors of Exercise Adherence (Personality Traits)
Aikaikkuna: Baseline, Week 6, Week 12, and monthly up to 15 months.
|
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.
|
Baseline, Week 6, Week 12, and monthly up to 15 months.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- N20261110
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .