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Completed

NCT Number: NCT03668483

Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx

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.

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Key information

Conditions

Lung Transplantation Behavior Dyspnea Motor Activity Pathological Conditions, Signs and Symptoms Pulmonary Rehabilitation Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Rehabilitation

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2018
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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