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Completed

NCT Number: NCT03531138

Is it Possible to Use the Timed Performance Tests in Lung Transplantation Candidates to Determine the Exercise Capacity?

Lung transplantation candidates will be performed a 3-month hospital-based preoperative exercise training. A 6-minute walk test, a 10-meter walking speed test and a 5-times sit to stand test will be performed to determine the exercise capacity of the patient. The tests will be carried out at the beginning and end of rehabilitation. At each testing session, the tests will be performed sequentially by the same physiotherapist, giving 20 minute rest periods within the same day. It will be analyzed how the test data correlate with each other and how the delta values calculated for each test reflect the rehabilitation outcomes calculated after the exercise program.

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Key information

Conditions

Pulmonary Rehabilitation Exercise Capacity Exercise Test

Age range

18 year–65 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

Severe exercise intolerance exists in lung transplant candidates. Completion of the test period in the field tests used in determining the exercise capacity of these patients is extremely difficult. The exercise capacity, which is considered as an important criterion in the decision of the lung transplant decision and in the determination of the clinical profile of the patient, necessitates the development of different test methods which are more suitable for the application of the measurement in this patient population.

In this study lung transplantation candidates will be performed a 3-month hospital-based preoperative exercise training. A 6-minute walk test, a 10-meter walking speed test and a 5-times sit to stand test will be performed to determine the exercise capacity of the patient. The tests will be carried out at the beginning and end of rehabilitation. At each testing session, the tests will be performed sequentially by the same physiotherapist, giving 20 minute rest periods within the same day. It will be analyzed how the test data correlate with each other and how the delta values calculated for each test reflect the rehabilitation outcomes calculated after the exercise program.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • To be taken to the list for lung transplant
  • Do not have any addiction that may interfere with exercise

Exclusion criteria

-Do not accept to study

Treatment and study plan

Pulmonary Rehabilitation

Other

All patients will undergo supervised pulmonary rehabilitation program on 2 days per week for 3 months. Apart from that, they will ask to perform the home exercise program which is scheduled as 3 days per week and fill out the exercise follow-up form. Supervised exercise sessions consist of aerobic(treadmill walking, bicycle training, arm ergometer training) and strengthening training(free weights). A 6-min walk test, a 10-meter walking speed test and a 5 times sit to stand test will be performed to determine the exercise capacity of the patient. The tests will be carried out at the beginning and end of rehabilitation. At each testing session, the tests will be performed sequentially by the same physiotherapist, giving 20 minute rest periods within the same day.

Primary outcomes

  1. Change from baseline distance covered in six minute walking test at 3-months

    Time frame: 3-months

    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.

  2. Change from baseline 10-meter walking speed test at 3-months

    Time frame: 3-months

    The patient walks without assistance 10 meters (32.8 feet) and the time is measured.

  3. Change from baseline 5 times sit to stand test at 3-months

    Time frame: 3-months

    Patient stand up and sit as quickly as possible from a standard chair for 5 times.Introduction: "Stand up and sit down as quickly as possible 5times, keeping your arms folded across your chest. I'll be timing you with a stopwatch. Ready, begin".The time is measured. Lower times = better scores.

Secondary outcomes

  1. Change from baseline Modified Medical Research Council (mMRC) Dyspnea Scale score at 3-months

    Time frame: 3-months

    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.

  2. Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months

    Time frame: 3-months

    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.

  3. Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months.

    Time frame: 3-months

    It was conducted by using the Sensor Medics model 2400 (Yorba Linda, CA, USA), and according to the American Thoracic Society (ATS) guidelines.

  4. Change from baseline quadriceps femoris muscle strength at 3-months.

    Time frame: 3-months

    Muscle Strength will measure using a digital dynamometer (J-Tech Commander muscle testing device), wth three measurements make. Best result will be taken.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
Oct 30, 2018

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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