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Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668483
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
esra pehlivan, 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.

Condition or disease Intervention/treatment Phase
Lung Transplantation Pulmonary Rehabilitation Other: Pulmonary rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relation Between Upper and Lower Limb Muscle Strength With Exercise Capacity and Dyspnea in Patients With Awaiting Lung Transplantation
Actual Study Start Date : September 20, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

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Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Changes from baseline the muscle strength [ Time Frame: 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.

  2. Changes from baseline the hand grip strength. [ Time Frame: 5 minutes ]
    It was measured with hydraulic hand dynamometer calibrated in lbs.

  3. Changes from baseline the maximum inspiratory muscle pressure [ Time Frame: 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.

  4. Changes from baseline the distance covered in six-minute walk test [ Time Frame: 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.

  5. Changes from baseline the modified Medical Research Council (mMRC) scale [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668483


Locations
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Turkey
Yedikule Chest Disease Hospital
Istanbul, Zeytinburnu, Turkey, 34200
Sponsors and Collaborators
Istanbul Medipol University Hospital
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Responsible Party: esra pehlivan, Principal investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03668483    
Other Study ID Numbers: Tx_Muscle strenght
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by esra pehlivan, Istanbul Medipol University Hospital:
rehabilitation
exercise
maximal inspiratory pressure
walk test
muscle strength
dyspnea
lung transplantation
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory