Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx

Not Applicable

Completed

• Conditions: Pulmonary Rehabilitation; Lung Transplantation
• Interventions: Other: Pulmonary rehabilitation

• Registration Number: NCT03668483
• Lead Sponsor: Istanbul Medipol University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2018-09-20
• Status Verified: 2018-10
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Yedikule Chest Disease Hospital; 🇹🇷 Istanbul, Zeytinburnu, Turkey