Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx

NCT03668483 | Completed

• 1 other identifier: Tx_Muscle strenght
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation; Pulmonary Rehabilitation

Keywords

rehabilitation; exercise; maximal inspiratory pressure; walk test; muscle strength; dyspnea; lung transplantation

Outcome Measures

Primary Outcomes (5)

• 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

• Changes from baseline the hand grip strength.

  It was measured with hydraulic hand dynamometer calibrated in lbs.

  5 minutes

• 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

• 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

• 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

Study Arms (1)

Pulmonary Rehabilitation

EXPERIMENTAL

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

Interventions

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.

Pulmonary Rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Dont except to participate the study
• incompatibility with exhaust
• not completing the program

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Dyspnea

Condition Hierarchy (Ancestors)

Behavior; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 12, 2018
• Study Start: September 20, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 2, 2019

Record last verified: 2018-10

Locations

TU (1)