Lung Cancer Clinical Trial
Official title:
Outcomes of Pulmonary Rehabilitation After Lung Resection in Patients With Non-Small Cell Lung Cancer
NCT number | NCT04722393 |
Other study ID # | IKC123 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2017 |
Est. completion date | December 1, 2019 |
Verified date | January 2021 |
Source | Izmir Katip Celebi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | December 1, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ilknur Naz Gürsan | Izmir |
Lead Sponsor | Collaborator |
---|---|
Izmir Katip Celebi University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise Capacity | Six minutes walk test | up to 8 weeks | |
Secondary | 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). |
up to 8 weeks | |
Secondary | 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. | up to 8 weeks | |
Secondary | 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. | up to 8 weeks | |
Secondary | 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. | up to 8 weeks | |
Secondary | 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. | up to 8 weeks | |
Secondary | Body Mass Index | Body mass index is calculated by dividing body mass by the square of length in meters | up to 8 weeks |
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