Low Volume High Intensity Interval Training in Operated Lung Cancer Patients

Trial Title: Low Volume High Intensity Interval Training in Operated Lung Cancer Patients

NCT ID: NCT05837429

Condition: Lung Cancer
Non Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Low volume high intensity interval training
Aerobic exercise
Oxidative stress
Cardiopulmonary exercise test

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: Low Volume High Intensity Exercise Training
Description: 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.
Arm group label: Low Volume High Intensity Exercise Training

Intervention type: Behavioral
Intervention name: Aerobic Exercise Training
Description: 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.
Arm group label: Aerobic Exercise

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Ankara University

Address:
City: Ankara
Country: Turkey

Status: Recruiting

Contact:
Last name: Hamide Sahin-Yildiz, Msc

Phone: +905538557135
Email: hamideshn128@gmail.com

Investigator:
Last name: Hamide Sahin-Yildiz, Msc
Email: Sub-Investigator

Start date: April 6, 2023

Completion date: April 6, 2025

Lead sponsor:
Agency: Hacettepe University
Agency class: Other

Collaborator:
Agency: Ankara University
Agency class: Other

Source: Hacettepe University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05837429