Hematopoietic Stem Cell TransplantationNCT07049536
Physical Fitness of Allogeneic Stem Cell Transplant
An observational study of Hematopoietic Stem Cell Transplantation, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Hematopoietic stem cell transplantation is a treatment used to restore blood cell function in diseases of myeloid and lymphoid origin, which can be malignant or non-malignant. There are two types: autologous transplantation, which uses the patient's own stem cells, and allogeneic transplantation, which uses stem cells… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Assessment Group
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2025to 15 Jan 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 30 individuals will be included in the study, consisting of 15 adult patients who have undergone hematopoietic stem cell transplantation and meet the inclusion criteria from the Adult Bone Marrow Transplantation Unit, forming the research group, and 15 healthy individuals forming the control group. RPatients and healthy controls will be matched based on age and gender.The study will commence following Ethics Committee approval and will be conducted in accordance with the principles of the Declaration of Helsinki. Informed consent will be obtained from all participants included in the study.
Who may be able to join
- Currently receiving treatment in the Adult Bone Marrow Transplantation Unit
- Between 18 and 65 years of age
- Undergoing standard medical treatment including immunosuppressants, antibiotics, and other medications
- Clinically stable, able to walk, and cooperative
- No history of orthopedic, neurological, or cardiac disorders
Who cannot join
- Presence of cognitive impairments
- Orthopedic or neurological diseases that may affect the evaluation of physical fitness tests
- Presence of facial palsy
- Severe visual impairment or visual field defects
- Acute bleeding, hemoglobin level ≤ 8 g/dL, and platelet count ≤ 10,000/mm³
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Physical Fitness Parameters of Allogeneic Stem Cell Transplant Recipients
Hematopoietic stem cell transplantation is a treatment used to restore blood cell function in diseases of myeloid and lymphoid origin, which can be malignant or non-malignant. There are two types: autologous transplantation, which uses the patient's own stem cells, and allogeneic transplantation, which uses stem cells from a donor after a high-dose chemotherapy and radiotherapy preparation. This process can lead to complications such as immune reactions, infections, and organ toxicity, affecting the cardiovascular, musculoskeletal, and nervous systems. These complications often reduce physical activity, muscle strength, lung function, and quality of life.
Before transplantation, it is important to assess patients' comorbidities, functional status, and physical fitness to evaluate their ability to tolerate treatment and risk of complications. Low exercise tolerance and impaired physical function are linked to poorer outcomes. Objective tests of physical function provide valuable information about health status. Pre-transplant muscle strength and cardiopulmonary fitness influence post-transplant recovery, so comprehensive assessments are necessary.
Read more
Physiotherapy and rehabilitation support patients by preparing them for treatment, maintaining health during therapy, improving physical function after treatment, and enhancing quality of life in palliative care. Exercise improves functional capacity, quality of life, and daily activities, but symptoms like fatigue, pain, breathlessness, and muscle weakness, as well as other barriers, may limit participation.
Physical fitness is the body's ability to perform daily activities efficiently. Reduced fitness leads to frailty and decreased function, which are associated with increased treatment toxicity and mortality. Although the importance of physical fitness before transplantation is recognized, data from objective measurements are limited. Common pre-transplant assessments include lung function tests, walking tests, handgrip strength, and mobility tests.
This study aims to compare the health-related physical fitness of individuals undergoing allogeneic hematopoietic stem cell transplantation with healthy controls.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Assessment Group, Control Group
- Keywords
- physical fitness, stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment GroupOther
Allogeneic Stem Cell Transplant recipients will be evaluated with a supervisor physiotherapist for 2 days between the time they are admitted to the stem cell transplantation unit.
Control GroupOther
Adult healthy group with similar sociodemographic characteristics to the evaluation group.
| Study group | Role | What they receive |
|---|---|---|
| Transplantation Group | Adult patients who underwent hematopoietic stem cell transplantation Receives: Other: Assessment Group | |
| Control Group | Healthy adults Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in One Second
The volume of air that can be forcefully exhaled during the first second of a forced breath.
Measured: 4 weeks
Forced Vital Capacity
The total volume of air that can be forcibly exhaled after taking the deepest breath possible.
Measured: 4 weeks
Forced Expiratory Volume in One Second to Forced Vital Capacity Ratio
The percentage ratio of the volume of air exhaled in the first second to the total volume exhaled during the forced vital capacity test.
Measured: 4 weeks
Peak Expiratory Flow
The maximum speed of expiration during a forced breath.
Measured: 4 weeks
Physical Activity Level:
The level of physical activity will be assessed using the Turkish version of the short form of the International Physical Activity Questionnaire. This questionnaire was developed to measure health-related physical activity in populations and is both comprehensive and concise. It provides information on the time spent sitting, walking, and engaging in moderate and vigorous intensity physical activities.
The total score is calculated by multiplying the duration and frequency of the physical activities reported. The energy expenditure associated with physical activities is expressed in metabolic equivalent-minute scores. Based on the scoring, the questionnaire categorizes individuals into three physical activity levels: inactive, moderately active, and active.
The administration of the questionnaire can be conducted in two different formats: on paper or via a digital screen interface.
Measured: 4 weeks
Six-Minute Walk Test
Functional exercise capacity will be evaluated using the Six-Minute Walk Test in accordance with the criteria of the American Thoracic Society and the European Respiratory Society. In this test, the individual is instructed to walk as fast as possible back and forth between two cones placed 30 meters apart in a straight corridor.
Standardized encouragement phrases will be used throughout the test to motivate the participant. Vital signs will be assessed before and after the test, as well as during the recovery period. The total distance walked during the six-minute period will be recorded in meters, and the average walking speed will be calculated in meters per minute.
Measured: 4 weeks
Postural Assessment:
The Posture Analysis Form developed by Corbin will be used for the assessment of postural alignment. The evaluation will be conducted through visual observation from both lateral and posterior views. The presence and severity of postural deviations will be assessed. Each item in the form is scored based on the severity of the deviation as follows:
0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score will be used to classify the individual's overall postural status.
Measured: 4 weeks
Sit and Reach Test
Sit and Reach Test reflects lower body flexibility. In this test, the patient will be seated in front of a box with dimensions of 35 cm length, 45 cm width, 32 cm height, and after leaning his bare feet on the inner surface of the box, patient will try to move the bar on the plate as far as patient can with both hands, the value at the last point will be recorded in cm.
Measured: 4 weeks
Assessment of Respiratory Muscle Strength
Respiratory muscle strength will be evaluated by measuring maximum inspiratory mouth pressure and maximum expiratory mouth pressure using a portable electronic mouth pressure measurement device. Results will be recorded in cmH₂O.
Maximum inspiratory mouth pressure is defined as the pressure generated in the mouth during maximal inspiration against an occluded airway. For this measurement, participants will first perform a maximal expiration, after which the airway will be closed with a valve, and the participant will be asked to perform a maximal inspiration sustained for 1-3 seconds.
maximum expiratory mouth pressure refers to the pressure generated in the mouth during maximal expiration against a closed airway. For maximum expiratory mouth pressure measurement, after a maximal inspiration, the participant will be instructed to exhale maximally against the occluded airway for 1-3 seconds.
Measured: 4 weeks
Assessment of Peripheral Muscle Strength
Peripheral muscle strength will be assessed for the following muscle groups: shoulder abductors, shoulder flexors, elbow flexors and extensors for the upper extremity; and hip flexors and knee extensors for the lower extremity. Measurements will be performed using a portable manual muscle strength testing device (Model 01165, Lafayette, Indiana, United States of America).
Measured: 4 weeks
Grip strength
Grip strength will be assessed using a Jamar Hydraulic Hand Dynamometer (Jamar, Nottinghamshire, United Kingdom). Measurements will be performed in a seated position with the elbow flexed at 90 degrees and the wrist in a neutral position.
Measurements for both right and left sides will be repeated three times, and the best value obtained will be recorded in kilograms.
Measured: 4 weeks
30-Second Sit-to-Stand Test
In this test, the participant is asked to sit down and stand up from a standard chair as many times as possible within 30 seconds, without using their arms. The number of full stands completed within the allotted time is recorded. This test provides functional information about lower extremity muscle strength.
Measured: 4 weeks
Flamingo Balance Test
In this test, the participant is asked to stand barefoot in a flamingo-like position and maintain balance for as long as possible. The participant balances on one leg, while the other leg is flexed so that the foot touches the opposite knee. A stopwatch is started upon command. Each time balance is lost, the timer is paused, and restarted once balance is regained. The total number of balance losses within 1 minute is recorded. If the participant loses balance more than 15 times within the first 30 seconds, the test is terminated and scored as zero.
Measured: 4 weeks
Semmes-Weinstein Monofilament Test
This test is performed to assess light touch and pressure sensations. The assessment tool consists of a series of monofilaments with varying thickness and diameters. These monofilaments apply graded forces ranging from 0.086 grams to 448 grams. The evaluation begins with the smallest monofilament and proceeds sequentially to thicker ones. The test is stopped, and the value is recorded, when the smallest monofilament perceived by the participant is identified. The monofilaments are applied from the first to the fifth finger, moving from distal to proximal regions, on both anterior and posterior surfaces of the hand.
Measured: 4 weeks
Quality of Life Assessment
Quality of life, including physical and mental health components, will be assessed using the Short Form 36 Health Survey Questionnaire. The Short Form 36 is a 36-item self-report questionnaire that evaluates eight dimensions of health: physical functioning, role limitations due to physical health, role limitations due to emotional problems, social functioning, bodily pain, mental health, vitality, and general health perceptions. In addition to individual subscale scores, two summary scores-physical component summary and mental component summary-are calculated by combining the relevant subscales.
Measured: 4 weeks
Secondary outcomes (5)
Height
The vertical distance from the top of the head to the heels of the individual. It will be measured in centimeters.
Measured: 4 weeks
Weight
The mass of the individual's body in relation to gravity. It will be expressed in kilograms.
Measured: 4 weeks
Demographic data and physical characteristics
The sociodemographic status of the participants will be recorded with an evaluation form prepared by the researchers. Information on age, gender, dominant side, exercise habits will be questioned. Data regarding diagnosis, disease stage, and treatments (chemotherapy/radiotherapy) will be obtained from the hospital medical record information processing system.Participants' privacy will be respected throughout the study, and no photographs will be taken.
Measured: 4 weeks
Waist Circumference Measurement
To assess waist circumference, participants will be asked to stand upright with arms relaxed at their sides and feet together. A non-elastic measuring tape will be held horizontally and parallel to the ground, and the measurement will be taken from the narrowest part of the torso. The measurement will be performed twice, and the average of the two values will be recorded in centimeters.
Measured: 4 weeks
Hip Circumference Measurement:
Hip circumference will be measured with the participant standing with feet together. A non-elastic measuring tape will be placed horizontally at the widest part of the buttocks. The measurement will be taken twice, and the average of the two readings will be recorded in centimeters.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start30 Aug 2025
- Primary completion30 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Koce, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049536
- Sponsor's protocol ID
- 24-03
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2025
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Physical Fitness Parameters of Allogeneic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT07049536
- Acronym / sponsor ID
- 24-03
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- physical fitness, stem cell transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 3 Jul 2025 (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.
Hematopoietic stem cell transplantation is a treatment used to restore blood cell function in diseases of myeloid and lymphoid origin, which can be malignant or non-malignant. There are two types: autologous transplantation, which uses the patient's own stem cells, and allogeneic transplantation, which uses stem cells from a donor after a high-dose chemotherapy and radiotherapy preparation. This process can lead to complications such as immune reactions, infections, and organ toxicity, affecting the cardiovascular, musculoskeletal, and nervous systems. These complications often reduce physical activity, muscle strength, lung function, and quality of life.
Before transplantation, it is important to assess patients' comorbidities, functional status, and physical fitness to evaluate their ability to tolerate treatment and risk of complications. Low exercise tolerance and impaired physical function are linked to poorer outcomes. Objective tests of physical function provide valuable information about health status. Pre-transplant muscle strength and cardiopulmonary fitness influence post-transplant recovery, so comprehensive assessments are necessary.
Physiotherapy and rehabilitation support patients by preparing them for treatment, maintaining health during therapy, improving physical function after treatment, and enhancing quality of life in palliative care. Exercise improves functional capacity, quality of life, and daily activities, but symptoms like fatigue, pain, breathlessness, and muscle weakness, as well as other barriers, may limit participation.
Physical fitness is the body's ability to perform daily activities efficiently. Reduced fitness leads to frailty and decreased function, which are associated with increased treatment toxicity and mortality. Although the importance of physical fitness before transplantation is recognized, data from objective measurements are limited. Common pre-transplant assessments include lung function tests, walking tests, handgrip strength, and mobility tests.
This study aims to compare the health-related physical fitness of individuals undergoing allogeneic hematopoietic stem cell transplantation with healthy controls.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplantation Group | – | Other: Assessment GroupAdult patients who underwent hematopoietic stem cell transplantation |
| Control Group | – | Other: Control GroupHealthy adults |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 individuals will be included in the study, consisting of 15 adult patients who have undergone hematopoietic stem cell transplantation and meet the inclusion criteria from the Adult Bone Marrow Transplantation Unit, forming the research group, and 15 healthy individuals forming the control group. RPatients and healthy controls will be matched based on age and gender.The study will commence following Ethics Committee approval and will be conducted in accordance with the principles of the Declaration of Helsinki. Informed consent will be obtained from all participants included in the study.
Key inclusion criteria (5 listed)
- Currently receiving treatment in the Adult Bone Marrow Transplantation Unit
- Between 18 and 65 years of age
- Undergoing standard medical treatment including immunosuppressants, antibiotics, and other medications
- Clinically stable, able to walk, and cooperative
- No history of orthopedic, neurological, or cardiac disorders
Key exclusion criteria (5 listed)
- Presence of cognitive impairments
- Orthopedic or neurological diseases that may affect the evaluation of physical fitness tests
- Presence of facial palsy
- Severe visual impairment or visual field defects
- Acute bleeding, hemoglobin level ≤ 8 g/dL, and platelet count ≤ 10,000/mm³
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 |
|---|---|---|
| Assessment GroupAllogeneic Stem Cell Transplant recipients will be evaluated with a supervisor physiotherapist for 2 days between the time they are admitted to the stem cell transplantation unit. | Other | Transplantation Group |
| Control GroupAdult healthy group with similar sociodemographic characteristics to the evaluation group. | Other | Control Group |
Primary outcome
Forced Expiratory Volume in One Second
Time frame: 4 weeks
The volume of air that can be forcefully exhaled during the first second of a forced breath.
Forced Vital Capacity
Time frame: 4 weeks
The total volume of air that can be forcibly exhaled after taking the deepest breath possible.
Forced Expiratory Volume in One Second to Forced Vital Capacity Ratio
Time frame: 4 weeks
The percentage ratio of the volume of air exhaled in the first second to the total volume exhaled during the forced vital capacity test.
Peak Expiratory Flow
Time frame: 4 weeks
The maximum speed of expiration during a forced breath.
Physical Activity Level:
Time frame: 4 weeks
The level of physical activity will be assessed using the Turkish version of the short form of the International Physical Activity Questionnaire. This questionnaire was developed to measure health-related physical activity in populations and is both comprehensive and concise. It provides information on the time spent sitting, walking, and engaging in moderate and vigorous intensity physical activities. The total score is calculated by multiplying the duration and frequency of the physical activities reported. The energy expenditure associated with physical activities is expressed in metabolic equivalent-minute scores. Based on the scoring, the questionnaire categorizes individuals into three physical activity levels: inactive, moderately active, and active. The administration of the questionnaire can be conducted in two different formats: on paper or via a digital screen interface.
Six-Minute Walk Test
Time frame: 4 weeks
Functional exercise capacity will be evaluated using the Six-Minute Walk Test in accordance with the criteria of the American Thoracic Society and the European Respiratory Society. In this test, the individual is instructed to walk as fast as possible back and forth between two cones placed 30 meters apart in a straight corridor. Standardized encouragement phrases will be used throughout the test to motivate the participant. Vital signs will be assessed before and after the test, as well as during the recovery period. The total distance walked during the six-minute period will be recorded in meters, and the average walking speed will be calculated in meters per minute.
Postural Assessment:
Time frame: 4 weeks
The Posture Analysis Form developed by Corbin will be used for the assessment of postural alignment. The evaluation will be conducted through visual observation from both lateral and posterior views. The presence and severity of postural deviations will be assessed. Each item in the form is scored based on the severity of the deviation as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score will be used to classify the individual's overall postural status.
Sit and Reach Test
Time frame: 4 weeks
Sit and Reach Test reflects lower body flexibility. In this test, the patient will be seated in front of a box with dimensions of 35 cm length, 45 cm width, 32 cm height, and after leaning his bare feet on the inner surface of the box, patient will try to move the bar on the plate as far as patient can with both hands, the value at the last point will be recorded in cm.
Assessment of Respiratory Muscle Strength
Time frame: 4 weeks
Respiratory muscle strength will be evaluated by measuring maximum inspiratory mouth pressure and maximum expiratory mouth pressure using a portable electronic mouth pressure measurement device. Results will be recorded in cmH₂O. Maximum inspiratory mouth pressure is defined as the pressure generated in the mouth during maximal inspiration against an occluded airway. For this measurement, participants will first perform a maximal expiration, after which the airway will be closed with a valve, and the participant will be asked to perform a maximal inspiration sustained for 1-3 seconds. maximum expiratory mouth pressure refers to the pressure generated in the mouth during maximal expiration against a closed airway. For maximum expiratory mouth pressure measurement, after a maximal inspiration, the participant will be instructed to exhale maximally against the occluded airway for 1-3 seconds.
Assessment of Peripheral Muscle Strength
Time frame: 4 weeks
Peripheral muscle strength will be assessed for the following muscle groups: shoulder abductors, shoulder flexors, elbow flexors and extensors for the upper extremity; and hip flexors and knee extensors for the lower extremity. Measurements will be performed using a portable manual muscle strength testing device (Model 01165, Lafayette, Indiana, United States of America).
Grip strength
Time frame: 4 weeks
Grip strength will be assessed using a Jamar Hydraulic Hand Dynamometer (Jamar, Nottinghamshire, United Kingdom). Measurements will be performed in a seated position with the elbow flexed at 90 degrees and the wrist in a neutral position. Measurements for both right and left sides will be repeated three times, and the best value obtained will be recorded in kilograms.
30-Second Sit-to-Stand Test
Time frame: 4 weeks
In this test, the participant is asked to sit down and stand up from a standard chair as many times as possible within 30 seconds, without using their arms. The number of full stands completed within the allotted time is recorded. This test provides functional information about lower extremity muscle strength.
Flamingo Balance Test
Time frame: 4 weeks
In this test, the participant is asked to stand barefoot in a flamingo-like position and maintain balance for as long as possible. The participant balances on one leg, while the other leg is flexed so that the foot touches the opposite knee. A stopwatch is started upon command. Each time balance is lost, the timer is paused, and restarted once balance is regained. The total number of balance losses within 1 minute is recorded. If the participant loses balance more than 15 times within the first 30 seconds, the test is terminated and scored as zero.
Semmes-Weinstein Monofilament Test
Time frame: 4 weeks
This test is performed to assess light touch and pressure sensations. The assessment tool consists of a series of monofilaments with varying thickness and diameters. These monofilaments apply graded forces ranging from 0.086 grams to 448 grams. The evaluation begins with the smallest monofilament and proceeds sequentially to thicker ones. The test is stopped, and the value is recorded, when the smallest monofilament perceived by the participant is identified. The monofilaments are applied from the first to the fifth finger, moving from distal to proximal regions, on both anterior and posterior surfaces of the hand.
Quality of Life Assessment
Time frame: 4 weeks
Quality of life, including physical and mental health components, will be assessed using the Short Form 36 Health Survey Questionnaire. The Short Form 36 is a 36-item self-report questionnaire that evaluates eight dimensions of health: physical functioning, role limitations due to physical health, role limitations due to emotional problems, social functioning, bodily pain, mental health, vitality, and general health perceptions. In addition to individual subscale scores, two summary scores-physical component summary and mental component summary-are calculated by combining the relevant subscales.
5 secondary outcomes
Height
Time frame: 4 weeks
Weight
Time frame: 4 weeks
Demographic data and physical characteristics
Time frame: 4 weeks
Waist Circumference Measurement
Time frame: 4 weeks
Hip Circumference Measurement:
Time frame: 4 weeks
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 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Hematopoietic Stem Cell Transplantation, run by Istinye University 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 5 inclusion and 5 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 26 Jan 2026. 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?
Forced Expiratory Volume in One Second (time frame: 4 weeks). The study lists 15 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 26 Jan 2026.