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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03881046
Other study ID # GO 18/737-08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date June 17, 2020

Study information

Verified date January 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of our study was to compare the daily living activities with a performance-based protocol in lung cancer patients and healthy controls.


Description:

Lung cancer is the abnormal proliferation of cells in the lung tissue and a mass in the lung. The primary symptoms of this health problem include cough, dyspnea, chest pain, hemoptysis and sputum. In addition to these symptoms, muscle strength, respiratory function and effort level are decreased. Inadequate daily living activities in cancer patients are expressed.But studies evaluating the activities of daily living in patients with lung cancer are inadequate and patients are evaluated only using scales. For the measurement of functional status in daily living activities, these scales provide important information about the detection of symptoms and the progression of the disease. However, it is very difficult to determine the limitation of perceived difficulty in daily living activities with these scales. In addition, since these scales are a method of measurement, the objectivity is open to discussion. It is thought that a performance-based protocol will facilitate the detection of limitations and provide more objective findings. We think that the Londrina protocol fully reflects the activities of daily living and thus will give us an objective measurement. This study will show us the problem and its cause in daily life activities in patients with lung cancer.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date June 17, 2020
Est. primary completion date January 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria: - To have a diagnosis of lung cancer - Complete chemotherapy - Complete radiotherapy - Coopere, - Accepts participation in the study will be included in the study Exclusion Criteria: - Neurological, cognitive or orthopedic diseases that affect the measurements - Acute infection - Individuals with other chronic diseases that may affect their walking will not be included in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hamide Sahin Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Activities Of Daily Living Daily Living Activities will be evaluated using the Londrina Protocol.The protocol consists of 5 stations. Stations are including organizing books on the table, 18 meters walking by carrying 10% of body weight symmetrically, arranging books by putting them on shelves, hanging the laundry in the laundry basket and walking 18 meters. Individual will do these activities at his own pace and the time will be recorded at the end. 1st day
Secondary Life Quality Quality of life will be measured using Core Quality of Life Questionnaire (EORTC QLQ-C30) The questionnaire consists of 30 questions and provides information on quality of life and symptoms. 1st Day
Secondary Peripheral Muscle Strength Muscle strength will be evaluated by force measuring dynamometer device 3 times. M.Quadriceps Femoris, shoulder abduction, shoulder flexion, elbow flexion, elbow extension and hand grip strength of all cases will be measured. 1st Day
Secondary Dyspnoea Dyspnoea will be evaluated using the Medical Research Council Dyspnoea Scale. The Medical Research Council Dyspnoea Scale has a score of 0-4. In this scoring system 0 indicates that there is no dyspnoea, whereas 4 indicates that the dyspnoea is too high. 1st Day
Secondary Respiratory Functions Respiratory functions will be measured by spirometric measurement. This measurement will give us FEV1 FVC FEV1 / FVC values. 1st Day
Secondary Exercise Capacity 6 Minute walk test will be used.In the test, the person will be asked to walk as fast as possible in a 30-meter corridor and the walking distance will be recorded in 6 minutes. 1st Day
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