Pulmonary RehabilitationNCT03531138
Is it Possible to Use the Timed Performance Tests in Lung Transplantation Candidates to Determine the Exercise Capacity?
A study testing Pulmonary Rehabilitation in people with Pulmonary Rehabilitation and Exercise Capacity, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Rehabilitation, Exercise Capacity, Exercise Test
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2018to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be taken to the list for lung transplant
- Do not have any addiction that may interfere with exercise
Who cannot join
- -Do not accept to study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yedikule Chest Disease Hospital
Istanbul, Zeytinburnu, 34200
About 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.
Read the 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.
- Conditions
- Pulmonary Rehabilitation, Exercise Capacity, Exercise Test
- Being tested
- Pulmonary Rehabilitation
- Keywords
- performance test, exercise capacity, rehabilitation outcome, pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 3-months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start20 May 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary RehabilitationStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531138
- Sponsor's protocol ID
- performans_2018
- Status last verified
- Oct 2018
- First submitted
- 9 May 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible to Use the Timed Performance Tests in Lung Transplantation Candidates to Determine the Exercise Capacity?
- ClinicalTrials.gov ID
- NCT03531138
- Acronym / sponsor ID
- performans_2018
- Conditions
- Pulmonary Rehabilitation, Exercise Capacity, Exercise Test
- Keywords
- performance test, exercise capacity, rehabilitation outcome, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation group | Experimental | Other: Pulmonary RehabilitationAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be taken to the list for lung transplant
- Do not have any addiction that may interfere with exercise
Key exclusion criteria (1 listed)
- -Do not accept to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationAll 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. | Other | Pulmonary rehabilitation group |
Primary outcome
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.
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.
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.
4 secondary outcomes
Change from baseline Modified Medical Research Council (mMRC) Dyspnea Scale score at 3-months
Time frame: 3-months
Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months
Time frame: 3-months
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months.
Time frame: 3-months
Change from baseline quadriceps femoris muscle strength at 3-months.
Time frame: 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Rehabilitation
Active, not recruiting
Inspiratory Muscle Training Immediately After Lung Transplantation
Lung Transplantation, Chronic Lung Disease
Active, not recruiting
Effects of Structural Integration on Chest Wall Expansion Among COPD Patients
COPD (With - Without Rehabilitation)
Enrolling by invitationObservational study
Long-term Effects and Maintenance of Exercise Habits in Individuals With COPD
Rehabilitation, COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Effect of Video Game-Based Breathing Exercises on Respiratory Dysfunction in ACOS
Asthma-COPD Overlap Syndrome, Pulmonary Rehabilitation
Recruiting
Tele-Pulmonary Rehabilitation For Patients With Chronic Lung Diseases
COPD (Chronic Obstructive Pulmonary Disease), Rehabilitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Pulmonary Rehabilitation and Exercise Capacity, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline distance covered in six minute walking test at 3-months (time frame: 3-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018; AzTrials last refreshed its copy on 3 Nov 2026.