Low Volume High Intensity Interval Training in Operated Lung Cancer Patients

NCT ID: NCT05837429

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2025-04-06

Brief Summary

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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

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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.

Conditions

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Lung Cancer Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Low Volume High Intensity Exercise Training

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Aerobic Exercise Training

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Hamide Sahin-Yildiz

Principal Investigator, PT, Msc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamide Sahin-Yildiz, Msc,PT

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Ankara University

Ankara, Sıhhiye, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hamide Sahin-Yildiz, Msc,PT

Role: CONTACT

+903127364047

Facility Contacts

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Hamide Sahin-Yildiz, Msc

Role: primary

+905538557135

Other Identifiers

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04-194-22

Identifier Type: -

Identifier Source: org_study_id

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