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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03668483
Other study ID # Tx_Muscle strenght
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2018
Est. completion date August 1, 2019

Study information

Verified date October 2018
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Severe exercise intolerance and shortness of breath are present in lung transplant candidates. Clinical features that reveal these symptoms in terminal period lung patients vary and are unclear. The effect of peripheral muscle strength on exercise capacity and dyspnea will be examined in our study.


Description:

Yedikule Chest Diseases Patients who have been accepted to participate in the pre-operative rehabilitation program at the Pulmonary Rehabilitation Unit will be included in the study. A 6-min walk test, peripheral and respiratory muscle strength measurements, and a dyspnea rating scale Mmrc will be applied to the lung transplantation candidates who are trained in 3-month hospital-based preoperative exercise training in the Pulmonary Rehabilitation unit. The tests will be carried out at the beginning and end of rehabilitation. At each testing session, the tests will be performed by the same physiotherapist. The correlations of the test data with each other will be analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date August 1, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- have a diagnosis of terminally severe lung disease,

- being listed for lung transplantation,

- medically stable,

- had no orthopedic or cardiac problems that would prevent them from exercising

- had no transfer problem to the pulmonary rehabilitation center.

Exclusion Criteria:

- Dont except to participate the study

- incompatibility with exhaust

- not completing the program

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary rehabilitation
A 6-min walk test, peripheral and respiratory muscle strength measurements, and a dyspnea rating scale Mmrc will be applied to the lung transplantation candidates who are trained in 3-month hospital-based preoperative exercise training in the Pulmonary Rehabilitation unit. The tests will be carried out at the beginning and end of rehabilitation.

Locations

Country Name City State
Turkey Yedikule Chest Disease Hospital Istanbul Zeytinburnu

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline the muscle strength Muscle strength will measure using a digital dynamometer (J-Tech Commander muscle testing device), wth three measurements make. Best result will be taken. 15 minutes
Primary Changes from baseline the hand grip strength. It was measured with hydraulic hand dynamometer calibrated in lbs. 5 minutes
Primary Changes from baseline the maximum inspiratory muscle pressure 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. 15 minutes
Primary Changes from baseline the distance covered in six-minute walk test 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. 20 minutes
Primary Changes from baseline the modified Medical Research Council (mMRC) scale 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. 5 minutes
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