Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05837429 |
| Other study ID # |
04-194-22 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 6, 2023 |
| Est. completion date |
April 6, 2025 |
Study information
| Verified date |
April 2023 |
| Source |
Hacettepe University |
| Contact |
Hamide Sahin-Yildiz, Msc,PT |
| Phone |
+905538557135 |
| Email |
hamideshn128[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
