Lung Resection and Pulmonary Rehabilitation
Primary Purpose
Pulmonary Rehabilitation, Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by

About this trial
This is an interventional treatment trial for Pulmonary Rehabilitation focused on measuring pulmonary rehabilitation, lung surgery, lung cancer
Eligibility Criteria
Inclusion Criteria:
- Patients who had undergone surgery for non-small cell lung cancer in the last two years
- Patients who had no chemotherapy or radiotherapy
Exclusion Criteria:
- Patients who were found unsuitable with the cardiology consultation
- Patients with psychiatric problems
- Patients with severe joint diseases
- Reluctant patients
Sites / Locations
- İlknur Naz Gürşan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Pulmonary Rehabilitation Group
Control Group
Arm Description
An 8-week comprehensive outpatient PR program including respiratory exercises, aerobic and strengthening training
Respiratory exercises
Outcomes
Primary Outcome Measures
Exercise Capacity
Six minutes walk test
Secondary Outcome Measures
Respiratory Functions
Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).
Dyspnea Sensation
Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. Higher scores mean a worse outcome.
Disease Specific Quality of Life
St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms. Higher scores mean a worse outcome.
Anxiety
Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Depression
Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Body Mass Index
Body mass index is calculated by dividing body mass by the square of length in meters
Full Information
NCT ID
NCT04722393
First Posted
January 13, 2021
Last Updated
January 20, 2021
Sponsor
Izmir Katip Celebi University
1. Study Identification
Unique Protocol Identification Number
NCT04722393
Brief Title
Lung Resection and Pulmonary Rehabilitation
Official Title
Outcomes of Pulmonary Rehabilitation After Lung Resection in Patients With Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi 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
Lung cancer is the most common cancer in the world and surgical resection remains the gold standard curative treatment in early stage non-small cell lung cancer. However, surgery itself is the direct cause of pulmonary function impairment, which dramatically reduces patients tolerance to exercise and their quality of life. Pulmonary rehabilitation (PR) complements surgical treatment and improves patients' exercise and functional capacity, decreases dyspnea, improves health status.
Our aim is to examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.
Detailed Description
Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, comprehensive exercise program that targets patients with symptomatic chronic respiratory disease. PR integrates exercise and training interventions into a personalized treatment program. PR has become an important component of the general treatment strategy in patients with high-risk surgical diseases such as lung resection. It helps patients return to normal not only physically, but also emotionally and mentally. In patients with lung cancer, preoperative PR increases exercise capacity, decreases post-operative morbidity and mortality. Although it is reported that the PR program applied in the post-operative period increases physical performance and improves the quality of life, referral of patients in need of the PR unit is less than 25%. There is a need to increase the awareness of both pulmonologists and thoracic surgeons about the benefits of the PR program, which is a non-pharmacological and effective intervention.
The investigators have had two objectives in this study. 1- To examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.
An 8-week comprehensive outpatient PR program will applied to half of 66 patients with non-small cell lung cancer who underwent lung resection, and the other half received respiratory exercise training. After the intervention, the results of both groups will compare.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Rehabilitation, Lung Cancer
Keywords
pulmonary rehabilitation, lung surgery, lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pulmonary Rehabilitation Group and Control Group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Rehabilitation Group
Arm Type
Experimental
Arm Description
An 8-week comprehensive outpatient PR program including respiratory exercises, aerobic and strengthening training
Arm Title
Control Group
Arm Type
Other
Arm Description
Respiratory exercises
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise training
Primary Outcome Measure Information:
Title
Exercise Capacity
Description
Six minutes walk test
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Respiratory Functions
Description
Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).
Time Frame
up to 8 weeks
Title
Dyspnea Sensation
Description
Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. Higher scores mean a worse outcome.
Time Frame
up to 8 weeks
Title
Disease Specific Quality of Life
Description
St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms. Higher scores mean a worse outcome.
Time Frame
up to 8 weeks
Title
Anxiety
Description
Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Time Frame
up to 8 weeks
Title
Depression
Description
Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Time Frame
up to 8 weeks
Title
Body Mass Index
Description
Body mass index is calculated by dividing body mass by the square of length in meters
Time Frame
up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who had undergone surgery for non-small cell lung cancer in the last two years
Patients who had no chemotherapy or radiotherapy
Exclusion Criteria:
Patients who were found unsuitable with the cardiology consultation
Patients with psychiatric problems
Patients with severe joint diseases
Reluctant patients
Facility Information:
Facility Name
İlknur Naz Gürşan
City
İzmir
ZIP/Postal Code
35620
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Lung Resection and Pulmonary Rehabilitation
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