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| Name | Class |
|---|---|
| Ankara University | OTHER |
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Patients included in the study will be randomly divided into 2 groups using appropriate randomization programs. All patients will be given exercise training individually for 24 sessions using a bicycle ergometer under the supervision of a physiotherapist.Patients in the first group will be given exercise training on a bicycle ergometer for 5 minutes warm-up phase at 40% of maximal oxygen consumption (VO2max), 20 minutes exercise phase at 60% of VO2max and 5 minutes cool down phase at 40% of VO2max for a total of 30 minutes. Patients in the second group will be given a warm-up phase for 3 minutes at 50% VO2max, 1 minute at 80-100% VO2max and 1 minute at 50% VO2max in 10 cycles, and finally a cool-down phase for 3 minutes at 50% VO2max. In total, 25 minutes of low-volume high-intensity intermittent exercise training will be given on a bicycle ergometer.
The study will include patients diagnosed with non-small cell lung cancer who have completed adjuvant treatments such as chemotherapy and radiotherapy at least 6 months ago, stage 3A or earlier,clinically stable remission (no recurrence or active cancer), and have been followed by Ankara University Medical Oncology Department. Patients who have undergone pneumonectomy surgery, patients with advanced COPD and cardiac disease, patients with orthopedic or neurological problems who cannot adapt to exercise will be excluded. Patients included in the study will be randomly divided into 2 groups using appropriate randomization programs. All patients will be given exercise training individually for 24 sessions using a bicycle ergometer under the supervision of a physiotherapist. To determine the intensity of exercise training, all patients will undergo Cardiopulmonary Exercise Test (CPET) on a bicycle ergometer under the supervision of a physiotherapist and a physician before the training sessions. During CPET, maximal oxygen capacity, diffusion capacity, heart rate variability as a marker of autonomic function and heart rate recovery will be measured. Patients in the first group will be given exercise training on a bicycle ergometer for 5 minutes warm-up phase at 40% of maximal oxygen consumption (VO2max), 20 minutes exercise phase at 60% of VO2max and 5 minutes cool down phase at 40% of VO2max for a total of 30 minutes. Patients in the second group will be given a warm-up phase for 3 minutes at 50% VO2max, 1 minute at 80-100% VO2max and 1 minute at 50% VO2max in 10 cycles, and finally a cool-down phase for 3 minutes at 50% VO2max. In total, 25 minutes of low-volume high-intensity intermittent exercise training will be given on a bicycle ergometer. After the exercise training, CPET will be performed again in the presence of a physician and physiotherapist to evaluate the effectiveness of the exercise. Blood samples of all groups will be taken by the physician before and after training to obtain information about the change in oxidative stress (total oxidant status, total antioxidant status) and myokine (irisin hormone) biomarkers between the two exercise modalities. Knee extensors and hand grip strength will be evaluated with a dynamometer as part of the peripheral muscle strength assessment of all groups before and after the training. EORTC QLQ-C30 quality of life questionnaire and London Chest Activities of Daily Living Scale will be used to evaluate the effect of exercise training on quality of life and activities of daily living before and after training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Volume High Intensity Exercise Training | Experimental | Patients in the intervention group will be given a warm-up phase for 3 minutes at 50% VO2max, 1 minute at 80-100% VO2max and 1 minute at 50% VO2max in 10 cycles, and finally a cool-down phase for 3 minutes at 50% VO2max. |
|
| Aerobic Exercise | Active Comparator | Patients in the control group will be given exercise training on a bicycle ergometer for 5 minutes warm-up phase at 40% of maximal oxygen consumption (VO2max), 20 minutes exercise phase at 60% of VO2max and 5 minutes cool down phase at 40% of VO2max for a total of 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Volume High Intensity Exercise Training | Behavioral | Patients in the intervention group will be given a warm-up phase for 3 minutes at 50% VO2max, 1 minute at 80-100% VO2max and 1 minute at 50% VO2max in 10 cycles, and finally a cool-down phase for 3 minutes at 50% VO2max. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal oxygen consumption | To be measured during cardiopulmonary exercise testing | 24 months |
| Heart Rate Variability | To be measured during cardiopulmonary exercise testing | 24 months |
| Oxidative Stress | Lipid peroxidation marker from serum for determination of oxidative damage melondialdehyde (MDA), total oxidant status (TOS), total antioxidant status (TAS) parameters will be evaluated. | 24 months |
| Myokine | Irisin levels in serum, enzyme-linked immunosorbent assay (Enzyme-Linked Immuno Sorbent Assay-ELISA) method using a commercial kit. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30 will be used for quality of life assessment. Higher scores reflect better function, whereas lower scores suggest impairment. | 24 months |
| Peripheral Muscle Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hamide Sahin-Yildiz, Msc,PT | Contact | +903127364047 | hamideshn128@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hamide Sahin-Yildiz, Msc,PT | Ankara University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University | Recruiting | Ankara | Sıhhiye | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Aerobic Exercise Training | Behavioral | Patients in the control group will be given exercise training on a bicycle ergometer for 5 minutes warm-up phase at 40% of maximal oxygen consumption (VO2max), 20 minutes exercise phase at 60% of VO2max and 5 minutes cool down phase at 40% of VO2max for a total of 30 minutes. |
|
The strength of the knee extensors will be measure using a digital dynamometer (Lafayette, Lafayette Instrument, Lafayette, IN, USA). The test will repeat 3 times on the dominant side and recorded in kilograms (kg). A Jamar hand dynamometer (Fabrication Enterprises, New York, USA) will be use to measure the handgrip strength. The measurement will repeat 3 times on the dominant side and recorded in kg. |
| 24 months |
| Activity of Daily Living | London Chest Activity of Daily Living Scale will be used for activity of daily living assessment. Low scores represent high activity. | 24 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |