Low Volume High Intensity Interval Training in Operated Lung Cancer Patients

NCT05837429 | Recruiting

• 1 other identifier: 04-194-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer

Keywords

Low volume high intensity interval training; Aerobic exercise; Oxidative stress; Cardiopulmonary exercise test

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in quality of life

  24 months

• Peripheral Muscle Strength

  24 months

• Activity of Daily Living

  24 months

Study Arms (2)

Low Volume High Intensity Exercise Training

EXPERIMENTAL

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

Aerobic Exercise

ACTIVE COMPARATOR

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

Interventions

Low Volume High Intensity Exercise Training 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.

Low Volume High Intensity Exercise Training

Aerobic Exercise Training 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.

Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Ankara University: collaborator

Study Sites (1)

Ankara University

Ankara, Sıhhiye, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Hamide Sahin-Yildiz, Msc,PT

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamide Sahin-Yildiz, Msc,PT

CONTACT

+903127364047; hamideshn128@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT, Msc

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: May 1, 2023
• Study Start: April 6, 2023
• Primary Completion: April 6, 2025
• Study Completion: April 6, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)