Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx

Lung Transplantation Clinical Trial

Official title:

Relation Between Upper and Lower Limb Muscle Strength With Exercise Capacity and Dyspnea in Patients With Awaiting Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668483
• Other study ID #: Tx_Muscle strenght
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dyspnea
• Lung Transplantation
• Pulmonary Rehabilitation

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-RPM® 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