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Low Volume High Intensity Interval Training in Operated Lung Cancer Patients

Primary Purpose

Lung Cancer, Non Small Cell Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low Volume High Intensity Exercise Training
Aerobic Exercise Training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Low volume high intensity interval training, Aerobic exercise, Oxidative stress, Cardiopulmonary exercise test

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ankara UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Volume High Intensity Exercise Training

Aerobic Exercise

Arm 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.

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.

Outcomes

Primary Outcome Measures

Maximal oxygen consumption
To be measured during cardiopulmonary exercise testing
Heart Rate Variability
To be measured during cardiopulmonary exercise testing
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.
Myokine
Irisin levels in serum, enzyme-linked immunosorbent assay (Enzyme-Linked Immuno Sorbent Assay-ELISA) method using a commercial kit.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 15, 2023
Last Updated
April 27, 2023
Sponsor
Hacettepe University
Collaborators
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT05837429
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
April 6, 2025 (Anticipated)
Study Completion Date
April 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non Small Cell Lung Cancer
Keywords
Low volume high intensity interval training, Aerobic exercise, Oxidative stress, Cardiopulmonary exercise test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Volume High Intensity Exercise Training
Arm Type
Experimental
Arm 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 Title
Aerobic Exercise
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Low Volume High Intensity Exercise Training
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise Training
Intervention 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.
Primary Outcome Measure Information:
Title
Maximal oxygen consumption
Description
To be measured during cardiopulmonary exercise testing
Time Frame
24 months
Title
Heart Rate Variability
Description
To be measured during cardiopulmonary exercise testing
Time Frame
24 months
Title
Oxidative Stress
Description
Lipid peroxidation marker from serum for determination of oxidative damage melondialdehyde (MDA), total oxidant status (TOS), total antioxidant status (TAS) parameters will be evaluated.
Time Frame
24 months
Title
Myokine
Description
Irisin levels in serum, enzyme-linked immunosorbent assay (Enzyme-Linked Immuno Sorbent Assay-ELISA) method using a commercial kit.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
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.
Time Frame
24 months
Title
Peripheral Muscle Strength
Description
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.
Time Frame
24 months
Title
Activity of Daily Living
Description
London Chest Activity of Daily Living Scale will be used for activity of daily living assessment. Low scores represent high activity.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamide Sahin-Yildiz, Msc,PT
Phone
+905538557135
Email
hamideshn128@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamide Sahin-Yildiz, Msc,PT
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara University
City
Ankara
State/Province
Sıhhiye
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamide Sahin-Yildiz, Msc
Phone
+905538557135
Email
hamideshn128@gmail.com
First Name & Middle Initial & Last Name & Degree
Hamide Sahin-Yildiz, Msc

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Volume High Intensity Interval Training in Operated Lung Cancer Patients

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