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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Rehabilitation; Exercise Capacity; Exercise Test
• Intervention / Treatment: Other: Pulmonary Rehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Zeytinburnu
    • Istanbul, Zeytinburnu, Turkey, 34200
      • Yedikule Chest Disease Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Pulmonary rehabilitation group; 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.

Other: Pulmonary Rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline distance covered in six minute walking test at 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.	3-months
Change from baseline 10-meter walking speed test at 3-months	The patient walks without assistance 10 meters (32.8 feet) and the time is measured.	3-months
Change from baseline 5 times sit to stand test at 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.	3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Modified Medical Research Council (mMRC) Dyspnea Scale score at 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.	3-months
Change from baseline Maximum Inspiratory Pressure (MIP) at 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-months
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 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.	3-months
Change from baseline quadriceps femoris muscle strength at 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.	3-months

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2018
• Primary Completion (ACTUAL): October 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (ACTUAL): May 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: exercise capacity; pulmonary rehabilitation; rehabilitation outcome; performance test
• Other Study ID Numbers: performans_2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No