Clinical trial NCT05837429: Low Volume High Intensity Interval Training in Operated Lung Cancer Patients
Official title: Comparison of the Effects of Continuous Aerobic Exercise Training and Low Volume High Intensity Interval Training on Cardiopulmonary Exercise Capacity, Autonomic Function and Oxidative Stress in Operated Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Keywords: Low volume high intensity interval training
Aerobic exercise
Oxidative stress
Cardiopulmonary exercise test
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Ankara University
First posted: 2023-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Non-Small Cell Lung Cancer
* Stage 3A and earlier
* Operated and at least 6 months have expired since the surgery
* Having completed adjuvant treatments such as chemotherapy and radiotherapy and at least 6 months have expired
* Being clinically stable and in remission
* Not having new recurrence and active cancer

Exclusion Criteria:

* Pneumonectomy surgery
* Presence of symptoms, signs and diagnoses indicating the presence of lung and cardiac disease such as advanced COPD
* Having any orthopedic or neurological problem that may prevent exercise
* Presence of recurrence or active cancer

Primary outcomes:
measure: Maximal oxygen consumption
timeFrame: 24 months
measure: Heart Rate Variability
timeFrame: 24 months
measure: Oxidative Stress
timeFrame: 24 months
measure: Myokine
timeFrame: 24 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: 24 months
measure: Peripheral Muscle Strength
timeFrame: 24 months
measure: Activity of Daily Living
timeFrame: 24 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
state: Sıhhiye
Study officials:
affiliation: Ankara University
name: Hamide Sahin-Yildiz, Msc,PT
role: PRINCIPAL_INVESTIGATOR
References: