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

NCT03531138 | Completed

• 1 other identifier: performans_2018
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Rehabilitation; Exercise Capacity; Exercise Test

Keywords

performance test; exercise capacity; rehabilitation outcome; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

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

  3-months

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

  3-months

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

  3-months

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

  3-months

Study Arms (1)

Pulmonary rehabilitation group

EXPERIMENTAL

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

Interventions

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.

Pulmonary rehabilitation group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Do not accept to study

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 21, 2018
• Study Start: May 20, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

TU (1)