Low Volume High Intensity Interval Training in Operated Lung Cancer Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Non Small Cell Lung Cancer
• Intervention / Treatment: Behavioral: Low Volume High Intensity Exercise Training; Behavioral: Aerobic Exercise Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hamide Sahin-Yildiz, Msc,PT; Phone Number: +903127364047; Email: hamideshn128@gmail.com

Study Locations

• Turkey
  • Sıhhiye
    • Ankara, Sıhhiye, Turkey
      • Recruiting
      • Ankara University
      • Contact: Hamide Sahin-Yildiz, Msc; Phone Number: +905538557135; Email: hamideshn128@gmail.com
      • Sub-Investigator: Hamide Sahin-Yildiz, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Volume High Intensity Exercise Training; 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.	Behavioral: Low Volume High Intensity Exercise Training; 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.
Active Comparator: Aerobic Exercise; 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.	Behavioral: Aerobic Exercise Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Collaborators: Ankara University
• Investigators: Principal Investigator: Hamide Sahin-Yildiz, Msc,PT, Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Estimated): April 6, 2025
• Study Completion (Estimated): April 6, 2025

Study Registration Dates

• First Submitted: April 15, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Oxidative stress; Aerobic exercise; Cardiopulmonary exercise test; Low volume high intensity interval training
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 04-194-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No