Pulmonary DiseaseNCT07455552
Smartphone-based Telerehabilitation Versus Home-based Inspiratory Muscle Training After Lung Resection in High-risk Patients
A study testing Smartphone-based telerehabilitation IMT and Unsupervised home-based IMT in people with Pulmonary Disease and Lung Cancer (Diagnosis), run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
The goal of this pilot clinical trial is to assess the feasibility of smartphone-based telerehabilitation for inspiratory muscle training (IMT) and to explore its preliminary effects on postoperative recovery in high-risk adult patients after lung resection. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pulmonary Disease, Lung Cancer (Diagnosis)
- What is being tested?
- Smartphone-based telerehabilitation IMT and Unsupervised home-based IMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2024to 1 Feb 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older
- Patients who underwent lung resection
- Patients who met at least one of the following high-risk criteria:
- preoperative FEV1 or DLCO ≤70% predicted
- age ≥65 years
- Patients who understood the study procedures and provided written informed consent
Who cannot join
- Pregnant women or other vulnerable populations considered inappropriate for study participation
- Patients with limited mobility due to other conditions that could interfere with the exercise stress test or 6-minute walk test (e.g., osteoarthritis, spinal disorders, or cerebral infarction)
- Patients with an implanted pacemaker or defibrillator that precluded bioelectrical impedance analysis
- Patients participating in other clinical studies that could affect exercise capacity
- Patients unable to independently use the messenger application (KakaoTalk) after standardized instruction
- Patients judged by the investigator to be unsuitable for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone-based Telerehabilitation Versus Unsupervised Home-based Inspiratory Muscle Training After Lung Resection in High-risk Patients: a Pilot Randomized Controlled Trial
The goal of this pilot clinical trial is to assess the feasibility of smartphone-based telerehabilitation for inspiratory muscle training (IMT) and to explore its preliminary effects on postoperative recovery in high-risk adult patients after lung resection. Eligible participants are adults aged 19 years or older who underwent lung resection and met at least one high-risk criterion: preoperative forced expiratory volume in 1 second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) of 70% predicted or less, or age 65 years or older. The main questions it aims to answer are:
Is smartphone-based telerehabilitation for IMT feasible and safe in this patient population? Does smartphone-based telerehabilitation for IMT show preliminary effects on functional exercise capacity, as measured by the 6-minute walk test (6MWT)? Researchers will compare smartphone-based telerehabilitation IMT with unsupervised home-based IMT to see whether remote supervision provides additional benefit after lung resection.
Read more
Participants will:
be randomized to either smartphone-based telerehabilitation IMT or unsupervised home-based IMT perform IMT 5 days per week for 6 weeks, starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance complete outcome assessments at postoperative weeks 2-4, 8-10, and 14-16, including the 6MWT, pulmonary function tests (FVC, FEV1, MIP, and peak expiratory flow), handgrip strength, body composition, patient-reported outcomes, and cardiopulmonary exercise testing at final follow-up
Read the detailed description
Eligible patients who undergo lung resection will be screened during postoperative hospitalization and before their first outpatient visit to the Department of Rehabilitation Medicine. To be eligible, participants must be adults aged 19 years or older, have undergone lung resection, meet at least one of the following high-risk criteria: preoperative forced expiratory volume in 1 second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) of 70% predicted or less, or age 65 years or older, and be able to understand the study procedures and provide written informed consent. Within 7 days after surgery and before hospital discharge, informed consent will be obtained and participants will be randomized in a 1:1 ratio to either the intervention or control group.
At postoperative weeks 2-4 (Visit 1), both groups will attend an outpatient visit for baseline assessments, including the 6-minute walk test (6MWT), pulmonary function tests (FVC, FEV1, MIP, and peak expiratory flow [PEF]), handgrip strength, body composition (InBody), EQ-5D, the Korean version of the Physical Activity Scale for the Elderly (K-PASE), and the Numeric Rating Scale (NRS) for pain. All participants will be instructed to continue the standard pulmonary rehabilitation program initiated during hospitalization, including breathing exercises, coughing techniques, early ambulation, and low-intensity aerobic exercise.
The intervention group will perform inspiratory muscle training (IMT) 5 days per week (10 repetitions × 10 sets per day) for 6 weeks. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP) and will be adjusted according to tolerance and symptoms, with a target of 50% of postoperative MIP and an upper limit of 4 on the Borg Dyspnea Scale. Smartphone-based telerehabilitation will be delivered through a mobile messenger application (e.g., KakaoTalk) and will include twice-weekly adherence and symptom monitoring, therapist feedback, and remote support for training progression. Communication will primarily be conducted through messaging, with telephone contact used as needed. Participants will also be able to contact the research team to ask questions or report adverse events during the intervention period, and the research team will respond within 24 hours.
The control group will perform the same IMT protocol for 6 weeks after a one-time instruction session at Visit 1, but without additional remote monitoring. Training will also begin at 20% of postoperative MIP, and participants will adjust the intensity independently based on tolerance. They will be instructed to reduce the load if they are unable to complete the prescribed training volume at the increased intensity.
Follow-up assessments will be conducted at postoperative weeks 8-10 (Visit 2) and 14-16 (Visit 3). Visit 2 will include reassessment of the same parameters measured at Visit 1 and review of exercise adherence. Visit 3 will include final outcome assessments and cardiopulmonary exercise testing (CPET).
- Conditions
- Pulmonary Disease, Lung Cancer (Diagnosis)
- Being tested
- Smartphone-based telerehabilitation IMT, Unsupervised home-based IMT
- Keywords
- Lung Resection, Inspiratory Muscle Training, Telerehabilitation, Postoperative Rehabilitation, High-risk Patients, KakaoTalk
- Medical subject headings
- Lung Diseases, Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based telerehabilitation IMTBehavioural
Home-based inspiratory muscle training performed for 6 weeks (5 days per week, 10 repetitions × 10 sets per day), starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance and symptoms. Participants receive smartphone-based telerehabilitation support through a mobile messenger application, including adherence checks, symptom monitoring, therapist feedback, and remote support for training progression.
Unsupervised home-based IMTBehavioural
Home-based inspiratory muscle training performed for 6 weeks (5 days per week, 10 repetitions × 10 sets per day), starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance. After a one-time instruction session, participants continue the training independently without additional remote monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-based telerehabilitation IMT | Experimental | Participants in this group will perform inspiratory muscle training (IMT) at home for 6 weeks (5 days per week, 10 repetitions × 10 sets per day) with smartphone-based telerehabilitation support. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP) and be adjusted according to tolerance and symptoms, with a target of 50% of postoperative MIP. Support will be delivered through a mobile messenger application (e.g., KakaoTalk) and will include twice-weekly adherence and symptom monitoring, therapist feedback, and remote support for training progression. Telephone contact will be used as needed. Receives: Behavioral: Smartphone-based telerehabilitation IMT |
| Unsupervised home-based IMT | Active comparator | Participants in this group will perform the same inspiratory muscle training (IMT) protocol at home for 6 weeks (5 days per week, 10 repetitions × 10 sets per day) after a one-time instruction session at the postoperative week 2-4 outpatient visit. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP), and participants will adjust the intensity independently based on tolerance, with a target of up to 50% of postoperative MIP. No additional remote monitoring or supervision will be provided after the initial instruction session. Receives: Behavioral: Unsupervised home-based IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
6minute walking test
Total distance walked in meters during a 6-minute walk test performed on a 30-meter flat indoor course to assess functional exercise capacity and postoperative recovery.
Measured: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Secondary outcomes (8)
Forced Vital Capacity (FVC)
Forced vital capacity (FVC) measured using standardized spirometry, reported in liters (L).
Measured: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
FEV1
Forced expiratory volume in 1 second (FEV1) measured using standardized spirometry, reported in liters (L).
Measured: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
MIP
Maximal inspiratory pressure (MIP) measured using standardized spirometry, reported in cmH2O.
Measured: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF) measured using standardized spirometry. Participants exhale as forcefully as possible after deep inhalation, and the highest value from three attempts is recorded.
Measured: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Hand grip strength
Handgrip strength measured using a handheld dynamometer. Participants perform three trials with the dominant hand, and the highest value is recorded.
Measured: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Bioelectric Impedance Analysis
Body composition assessed using bioelectrical impedance analysis (InBody S10), including skeletal muscle mass, skeletal muscle index, phase angle, and fat-free mass.
Measured: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Questionnaires (EQ-5D-5L, EQ-VAS, and K-PASE)
Health-related quality of life was assessed using the EQ-5D-5L and EQ visual analogue scale (EQ-VAS). Self-reported physical activity related to leisure, household activities, and work was assessed using the Korean version of the Physical Activity Scale for the Elderly (K-PASE).
Measured: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Cardiopulmonary Exercise Test (CPET)
Cardiopulmonary exercise testing (CPET) performed at final follow-up. Parameters include peak oxygen uptake (VO2 peak), predicted VO2 peak, ventilatory efficiency (VE/VCO2 slope), anaerobic threshold, respiratory exchange ratio, and maximal heart rate.
Measured: Visit 3 (14 to 16 weeks after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start13 Aug 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to either a smartphone-based telerehabilitation IMT group or a self-managed home-based IMT group in a parallel two-arm design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Sponsor
- Investigators
- Sanghun Kim, MD,PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455552
- Sponsor's protocol ID
- 2407-025-140
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-based Telerehabilitation Versus Unsupervised Home-based Inspiratory Muscle Training After Lung Resection in High-risk Patients: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07455552
- Acronym / sponsor ID
- 2407-025-140
- Conditions
- Pulmonary Disease, Lung Cancer (Diagnosis)
- Keywords
- Lung Resection, Inspiratory Muscle Training, Telerehabilitation, Postoperative Rehabilitation, High-risk Patients, KakaoTalk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 6 Mar 2026 (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.
The goal of this pilot clinical trial is to assess the feasibility of smartphone-based telerehabilitation for inspiratory muscle training (IMT) and to explore its preliminary effects on postoperative recovery in high-risk adult patients after lung resection. Eligible participants are adults aged 19 years or older who underwent lung resection and met at least one high-risk criterion: preoperative forced expiratory volume in 1 second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) of 70% predicted or less, or age 65 years or older. The main questions it aims to answer are:
Is smartphone-based telerehabilitation for IMT feasible and safe in this patient population? Does smartphone-based telerehabilitation for IMT show preliminary effects on functional exercise capacity, as measured by the 6-minute walk test (6MWT)? Researchers will compare smartphone-based telerehabilitation IMT with unsupervised home-based IMT to see whether remote supervision provides additional benefit after lung resection.
Participants will:
be randomized to either smartphone-based telerehabilitation IMT or unsupervised home-based IMT perform IMT 5 days per week for 6 weeks, starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance complete outcome assessments at postoperative weeks 2-4, 8-10, and 14-16, including the 6MWT, pulmonary function tests (FVC, FEV1, MIP, and peak expiratory flow), handgrip strength, body composition, patient-reported outcomes, and cardiopulmonary exercise testing at final follow-up
Detailed description
Eligible patients who undergo lung resection will be screened during postoperative hospitalization and before their first outpatient visit to the Department of Rehabilitation Medicine. To be eligible, participants must be adults aged 19 years or older, have undergone lung resection, meet at least one of the following high-risk criteria: preoperative forced expiratory volume in 1 second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) of 70% predicted or less, or age 65 years or older, and be able to understand the study procedures and provide written informed consent. Within 7 days after surgery and before hospital discharge, informed consent will be obtained and participants will be randomized in a 1:1 ratio to either the intervention or control group.
At postoperative weeks 2-4 (Visit 1), both groups will attend an outpatient visit for baseline assessments, including the 6-minute walk test (6MWT), pulmonary function tests (FVC, FEV1, MIP, and peak expiratory flow [PEF]), handgrip strength, body composition (InBody), EQ-5D, the Korean version of the Physical Activity Scale for the Elderly (K-PASE), and the Numeric Rating Scale (NRS) for pain. All participants will be instructed to continue the standard pulmonary rehabilitation program initiated during hospitalization, including breathing exercises, coughing techniques, early ambulation, and low-intensity aerobic exercise.
The intervention group will perform inspiratory muscle training (IMT) 5 days per week (10 repetitions × 10 sets per day) for 6 weeks. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP) and will be adjusted according to tolerance and symptoms, with a target of 50% of postoperative MIP and an upper limit of 4 on the Borg Dyspnea Scale. Smartphone-based telerehabilitation will be delivered through a mobile messenger application (e.g., KakaoTalk) and will include twice-weekly adherence and symptom monitoring, therapist feedback, and remote support for training progression. Communication will primarily be conducted through messaging, with telephone contact used as needed. Participants will also be able to contact the research team to ask questions or report adverse events during the intervention period, and the research team will respond within 24 hours.
The control group will perform the same IMT protocol for 6 weeks after a one-time instruction session at Visit 1, but without additional remote monitoring. Training will also begin at 20% of postoperative MIP, and participants will adjust the intensity independently based on tolerance. They will be instructed to reduce the load if they are unable to complete the prescribed training volume at the increased intensity.
Follow-up assessments will be conducted at postoperative weeks 8-10 (Visit 2) and 14-16 (Visit 3). Visit 2 will include reassessment of the same parameters measured at Visit 1 and review of exercise adherence. Visit 3 will include final outcome assessments and cardiopulmonary exercise testing (CPET).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to either a smartphone-based telerehabilitation IMT group or a self-managed home-based IMT group in a parallel two-arm design.
| Arm | Type | Receives |
|---|---|---|
| Smartphone-based telerehabilitation IMT | Experimental | Behavioral: Smartphone-based telerehabilitation IMTParticipants in this group will perform inspiratory muscle training (IMT) at home for 6 weeks (5 days per week, 10 repetitions × 10 sets per day) with smartphone-based telerehabilitation support. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP) and be adjusted according to tolerance and symptoms, with a target of 50% of postoperative MIP. Support will be delivered through a mobile messenger application (e.g., KakaoTalk) and will include twice-weekly adherence and symptom monitoring, therapist feedback, and remote support for training progression. Telephone contact will be used as needed. |
| Unsupervised home-based IMT | Active comparator | Behavioral: Unsupervised home-based IMTParticipants in this group will perform the same inspiratory muscle training (IMT) protocol at home for 6 weeks (5 days per week, 10 repetitions × 10 sets per day) after a one-time instruction session at the postoperative week 2-4 outpatient visit. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP), and participants will adjust the intensity independently based on tolerance, with a target of up to 50% of postoperative MIP. No additional remote monitoring or supervision will be provided after the initial instruction session. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 19 years or older
- Patients who underwent lung resection
- Patients who met at least one of the following high-risk criteria:
- Patients who understood the study procedures and provided written informed consent
Key exclusion criteria (6 listed)
- Pregnant women or other vulnerable populations considered inappropriate for study participation
- Patients with limited mobility due to other conditions that could interfere with the exercise stress test or 6-minute walk test (e.g., osteoarthritis, spinal disorders, or cerebral infarction)
- Patients with an implanted pacemaker or defibrillator that precluded bioelectrical impedance analysis
- Patients participating in other clinical studies that could affect exercise capacity
- Patients unable to independently use the messenger application (KakaoTalk) after standardized instruction
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 |
|---|---|---|
| Smartphone-based telerehabilitation IMTHome-based inspiratory muscle training performed for 6 weeks (5 days per week, 10 repetitions × 10 sets per day), starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance and symptoms. Participants receive smartphone-based telerehabilitation support through a mobile messenger application, including adherence checks, symptom monitoring, therapist feedback, and remote support for training progression. | Behavioural | Smartphone-based telerehabilitation IMT |
| Unsupervised home-based IMTHome-based inspiratory muscle training performed for 6 weeks (5 days per week, 10 repetitions × 10 sets per day), starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance. After a one-time instruction session, participants continue the training independently without additional remote monitoring. | Behavioural | Unsupervised home-based IMT |
Primary outcome
6minute walking test
Time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Total distance walked in meters during a 6-minute walk test performed on a 30-meter flat indoor course to assess functional exercise capacity and postoperative recovery.
8 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
FEV1
Time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
MIP
Time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Peak Expiratory Flow (PEF)
Time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Hand grip strength
Time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Bioelectric Impedance Analysis
Time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Questionnaires (EQ-5D-5L, EQ-VAS, and K-PASE)
Time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Cardiopulmonary Exercise Test (CPET)
Time frame: Visit 3 (14 to 16 weeks after surgery).
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 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Sanghun Kim, MD,PhD principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based telerehabilitation IMT and Unsupervised home-based IMT in people with Pulmonary Disease and Lung Cancer (Diagnosis), run by Pusan National University Hospital at 1 site in South Korea.
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 6 inclusion and 6 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 24 Jun 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 South Korea. 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?
6minute walking test (time frame: Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).). 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 24 Jun 2026.