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Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx

Primary Purpose

Lung Transplantation, Pulmonary Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Transplantation focused on measuring rehabilitation, exercise, maximal inspiratory pressure, walk test, muscle strength, dyspnea, lung transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yedikule Chest Disease Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary Rehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Changes from baseline the hand grip strength.
It was measured with hydraulic hand dynamometer calibrated in lbs.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2018
Last Updated
November 28, 2019
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03668483
Brief Title
Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx
Official Title
Relation Between Upper and Lower Limb Muscle Strength With Exercise Capacity and Dyspnea in Patients With Awaiting Lung Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplantation, Pulmonary Rehabilitation
Keywords
rehabilitation, exercise, maximal inspiratory pressure, walk test, muscle strength, dyspnea, lung transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
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 Measure Information:
Title
Changes from baseline the muscle strength
Description
Muscle strength will measure using a digital dynamometer (J-Tech Commander muscle testing device), wth three measurements make. Best result will be taken.
Time Frame
15 minutes
Title
Changes from baseline the hand grip strength.
Description
It was measured with hydraulic hand dynamometer calibrated in lbs.
Time Frame
5 minutes
Title
Changes from baseline the maximum inspiratory muscle pressure
Description
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.
Time Frame
15 minutes
Title
Changes from baseline the distance covered in six-minute walk test
Description
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.
Time Frame
20 minutes
Title
Changes from baseline the modified Medical Research Council (mMRC) scale
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Yedikule Chest Disease Hospital
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34200
Country
Turkey

12. IPD Sharing Statement

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Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx

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