Pulmonary Rehabilitation Clinical Trial
Official title:
Is it Possible to Use the Timed Performance Tests in Lung Transplantation Candidates to Determine the Exercise Capacity?
Verified date | October 2018 |
Source | Istanbul Medipol University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Lung transplantation candidates will be performed a 3-month hospital-based preoperative exercise training. A 6-minute walk test, a 10-meter walking speed test and a 5-times sit to stand test will be performed to determine the exercise capacity of the patient. The tests will be carried out at the beginning and end of rehabilitation. At each testing session, the tests will be performed sequentially by the same physiotherapist, giving 20 minute rest periods within the same day. It will be analyzed how the test data correlate with each other and how the delta values calculated for each test reflect the rehabilitation outcomes calculated after the exercise program.
Status | Completed |
Enrollment | 43 |
Est. completion date | October 1, 2018 |
Est. primary completion date | October 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - To be taken to the list for lung transplant - Do not have any addiction that may interfere with exercise Exclusion Criteria: -Do not accept to study |
Country | Name | City | State |
---|---|---|---|
Turkey | Yedikule Chest Disease Hospital | Istanbul | Zeytinburnu |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medipol University Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline distance covered in six minute walking test at 3-months | The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk. Before and after the test, oxygen saturation, heart rate, Borg fatigue rating, and walking distance were recorded. | 3-months | |
Primary | Change from baseline 10-meter walking speed test at 3-months | The patient walks without assistance 10 meters (32.8 feet) and the time is measured. | 3-months | |
Primary | Change from baseline 5 times sit to stand test at 3-months | Patient stand up and sit as quickly as possible from a standard chair for 5 times.Introduction: "Stand up and sit down as quickly as possible 5times, keeping your arms folded across your chest. I'll be timing you with a stopwatch. Ready, begin".The time is measured. Lower times = better scores. | 3-months | |
Secondary | Change from baseline Modified Medical Research Council (mMRC) Dyspnea Scale score at 3-months | The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception. | 3-months | |
Secondary | Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months | The mouth pressure measurement was performed with the Micro-RPMĀ® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained. | 3-months | |
Secondary | Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months. | It was conducted by using the Sensor Medics model 2400 (Yorba Linda, CA, USA), and according to the American Thoracic Society (ATS) guidelines. | 3-months | |
Secondary | Change from baseline quadriceps femoris muscle strength at 3-months. | Muscle Strength will measure using a digital dynamometer (J-Tech Commander muscle testing device), wth three measurements make. Best result will be taken. | 3-months |
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