Chronic Respiratory DiseaseEffects of HigNCT07867535
High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease
A study testing Alternating Concentric-Eccentric High-Intensity Interval Training and Concentric High-Intensity Interval Training in people with Chronic Respiratory Disease and Chronic Obstructive Pulmonary Disease, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial summary
This randomized controlled trial aims to evaluate the effects of high-intensity interval training incorporating alternating concentric and eccentric cycling on functional performance in adults with chronic respiratory disease undergoing pulmonary rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Disease, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Alternating Concentric-Eccentric High-Intensity Interval Training and Concentric High-Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Oct 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent. Adults aged 18 years or older with chronic respiratory disease. Have participated in a pulmonary rehabilitation program for more than 3 months. For participants with an implanted cardioverter-defibrillator (ICD), the programmed maximum heart rate must be higher than the target heart rate used during exercise training.
- Considered medically suitable for exercise training by a specialist physician.
Who cannot join
- Presence of a tracheostomy. Use of long-term home oxygen therapy or home mechanical ventilation. Severe left-sided heart failure classified as New York Heart Association (NYHA) functional class III or IV.
- Diagnosis of a neuromuscular disease. Acute exacerbation of chronic obstructive pulmonary disease (COPD) within the previous 3 months.
- Unable to complete or cooperate with cardiopulmonary exercise testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Fu Jen Catholic University Hospital
New Taipei City, New Taipei City, 24352
Hui-Wen Hsu, M.S., +886-2-8512-8888 ext. 23426, 76wwocat@gmail.com
About this study
Official title: Effects of High-Intensity Interval Alternating Concentric-Eccentric Training on Functional Performance in Patients With Chronic Respiratory Disease: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of high-intensity interval training incorporating alternating concentric and eccentric cycling on functional performance in adults with chronic respiratory disease undergoing pulmonary rehabilitation. A total of 45 participants will be randomly assigned to one of three groups: high-intensity interval alternating concentric-eccentric training, high-intensity interval concentric training, or usual care. Participants in the exercise training groups will complete a 12-week supervised exercise program, while the usual-care group will continue routine care with self-regulated exercise intensity. Functional performance, exercise capacity, and patient-reported outcomes will be assessed before and after the intervention. The study seeks to determine whether incorporating eccentric exercise into high-intensity interval training can improve physical function while reducing cardiopulmonary and perceived exercise burden.
Read the detailed description
Chronic respiratory diseases, particularly chronic obstructive pulmonary disease (COPD), are commonly associated with exercise intolerance, dyspnea, peripheral muscle dysfunction, and reduced quality of life. Although exercise training is a central component of pulmonary rehabilitation, patients may have difficulty tolerating conventional high-intensity exercise because of ventilatory limitation and leg fatigue.
Eccentric exercise can generate relatively high mechanical workloads with lower oxygen consumption and cardiopulmonary demand than concentric exercise. High-intensity interval training (HIIT), on the other hand, is an effective approach for improving aerobic capacity. This study therefore investigates whether incorporating eccentric cycling into the recovery periods of HIIT can provide additional skeletal muscle stimulation without substantially increasing cardiopulmonary stress.
This is a single-center, prospective, randomized controlled trial conducted at Fu Jen Catholic University Hospital. Forty-five adults with chronic respiratory disease who have participated in pulmonary rehabilitation for more than 3 months will be enrolled and randomly allocated to three groups, with approximately 15 participants in each group: (1) high-intensity interval alternating concentric-eccentric training, (2) high-intensity interval concentric training, or (3) usual care.
Before randomization, participants will undergo graded exercise testing, functional performance assessments, and questionnaires. Participants assigned to the exercise groups will complete supervised training for 12 weeks. The alternating concentric-eccentric group will also undergo an eccentric exercise familiarization period before the formal training program. Participants in the usual-care group will continue routine care with self-regulated exercise intensity for 12 weeks. After the intervention, graded exercise testing, functional assessments, and questionnaires will be repeated.
The study will evaluate changes in functional performance, exercise capacity, muscle function, symptoms, and quality of life to determine whether alternating concentric-eccentric HIIT provides additional benefits compared with conventional concentric HIIT and usual care.
- Being tested
- Alternating Concentric-Eccentric High-Intensity Interval Training, Concentric High-Intensity Interval Training, Usual Care
- Keywords
- Pulmonary Rehabilitation, High-Intensity Interval Training, HIIT, Eccentric Exercise, Concentric Exercise, Concentric-Eccentric Training, Exercise Training, Functional Performance, Exercise Capacity, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating Concentric-Eccentric High-Intensity Interval TrainingBehavioural
Also called Alternating Concentric-Eccentric HIIT
Participants will complete a 2-week eccentric cycling familiarization period followed by 12 weeks of supervised high-intensity interval training, performed twice weekly. Each formal training session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of eccentric cycling performed at the same external workload as the high-intensity concentric interval.
Concentric High-Intensity Interval TrainingBehavioural
Also called Concentric HIIT
Participants will complete 12 weeks of supervised high-intensity interval concentric cycling training, performed twice weekly. Each session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of concentric cycling at 40% Wpeak.
Usual CareBehavioural
Participants will continue usual care with self-regulated exercise intensity for 12 weeks. No structured high-intensity interval or eccentric cycling training will be provided as part of the study intervention.
| Study group | Role | What they receive |
|---|---|---|
| Alternating Concentric-Eccentric HIIT | Experimental | Participants will undergo a 2-week eccentric cycling familiarization period followed by 12 weeks of high-intensity interval training. During the high-intensity intervals, concentric cycling will be performed at 80% of peak work rate, while the recovery intervals will use eccentric cycling at the same external workload. Receives: Behavioral: Alternating Concentric-Eccentric High-Intensity Interval Training |
| Concentric HIIT | Active comparator | Participants will undergo 12 weeks of high-intensity interval concentric cycling training. High-intensity intervals will be performed at 80% of peak work rate, with recovery intervals performed concentrically at 40% of peak work rate. Receives: Behavioral: Concentric High-Intensity Interval Training |
| Usual Care | Active comparator | Participants will continue usual care with self-regulated exercise intensity for 12 weeks. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Minute Walk Distance
The 6-minute walk test will be used to assess functional exercise capacity. The distance walked in 6 minutes on a 30-meter indoor corridor will be recorded in meters. Change from baseline to post-intervention will be compared among the three study groups.
Measured: Baseline and 12 weeks
Change in Timed Up and Go Test
The Timed Up and Go test will be used to assess functional mobility, balance, and gait performance. Participants will stand from a chair, walk 3 meters, turn, return to the chair, and sit down. Three trials will be performed, and the fastest completion time in seconds will be used for analysis.
Measured: Baseline and 12 weeks
Change in Stair Climbing Performance
Stair climbing performance will be assessed using a fixed number of stairs to evaluate lower-extremity strength, balance, agility, and functional performance. Completion time will be recorded in seconds.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change in St. George's Respiratory Questionnaire Score
Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ). Changes in total score from baseline to post-intervention will be evaluated.
Measured: Baseline and after 12 weeks of formal training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start6 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in parallel to one of three groups: alternating concentric-eccentric high-intensity interval training, concentric high-intensity interval training, or usual care.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Wen Hsu, M.S., Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867535
- Sponsor's protocol ID
- FJUH115600
- Acronym
- Effects of Hig
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chao KY, Liu WL, Hsu HW, Chen HC, Lim AY, Wang JS. Eccentric cycling for chronic respiratory disease: Does helmet ventilation add value? A randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251404870. doi: 10.1177/14799731251404870. Epub 2025 Nov 25.
PubMed 41290215Inostroza M, Valdes O, Tapia G, Nunez O, Kompen MJ, Nosaka K, Penailillo L. Effects of eccentric vs concentric cycling training on patients with moderate COPD. Eur J Appl Physiol. 2022 Feb;122(2):489-502. doi: 10.1007/s00421-021-04850-x. Epub 2021 Nov 20.
PubMed 34799753Milanovic Z, Sporis G, Weston M. Effectiveness of High-Intensity Interval Training (HIT) and Continuous Endurance Training for VO2max Improvements: A Systematic Review and Meta-Analysis of Controlled Trials. Sports Med. 2015 Oct;45(10):1469-81. doi: 10.1007/s40279-015-0365-0.
PubMed 26243014Harrison AJ, Burdon CA, Groeller H, Peoples GE. The Acute Physiological Responses of Eccentric Cycling During the Recovery Periods of a High Intensity Concentric Cycling Interval Session. Front Physiol. 2020 Apr 17;11:336. doi: 10.3389/fphys.2020.00336. eCollection 2020.
PubMed 32362839Pancera S, Lopomo NF, Porta R, Sanniti A, Buraschi R, Bianchi LNC. Effects of Combined Endurance and Resistance Eccentric Training on Muscle Function and Functional Performance in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Mar;105(3):470-479. doi: 10.1016/j.apmr.2023.09.004. Epub 2023 Sep 15.
PubMed 37716519
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Interval Alternating Concentric-Eccentric Training on Functional Performance in Patients With Chronic Respiratory Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07867535
- Acronym / sponsor ID
- Effects of Hig / FJUH115600
- Keywords
- Pulmonary Rehabilitation, High-Intensity Interval Training, HIIT, Eccentric Exercise, Concentric Exercise, Concentric-Eccentric Training, Exercise Training, Functional Performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 6 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Oct 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.
This randomized controlled trial aims to evaluate the effects of high-intensity interval training incorporating alternating concentric and eccentric cycling on functional performance in adults with chronic respiratory disease undergoing pulmonary rehabilitation. A total of 45 participants will be randomly assigned to one of three groups: high-intensity interval alternating concentric-eccentric training, high-intensity interval concentric training, or usual care. Participants in the exercise training groups will complete a 12-week supervised exercise program, while the usual-care group will continue routine care with self-regulated exercise intensity. Functional performance, exercise capacity, and patient-reported outcomes will be assessed before and after the intervention. The study seeks to determine whether incorporating eccentric exercise into high-intensity interval training can improve physical function while reducing cardiopulmonary and perceived exercise burden.
Detailed description
Chronic respiratory diseases, particularly chronic obstructive pulmonary disease (COPD), are commonly associated with exercise intolerance, dyspnea, peripheral muscle dysfunction, and reduced quality of life. Although exercise training is a central component of pulmonary rehabilitation, patients may have difficulty tolerating conventional high-intensity exercise because of ventilatory limitation and leg fatigue.
Eccentric exercise can generate relatively high mechanical workloads with lower oxygen consumption and cardiopulmonary demand than concentric exercise. High-intensity interval training (HIIT), on the other hand, is an effective approach for improving aerobic capacity. This study therefore investigates whether incorporating eccentric cycling into the recovery periods of HIIT can provide additional skeletal muscle stimulation without substantially increasing cardiopulmonary stress.
This is a single-center, prospective, randomized controlled trial conducted at Fu Jen Catholic University Hospital. Forty-five adults with chronic respiratory disease who have participated in pulmonary rehabilitation for more than 3 months will be enrolled and randomly allocated to three groups, with approximately 15 participants in each group: (1) high-intensity interval alternating concentric-eccentric training, (2) high-intensity interval concentric training, or (3) usual care.
Before randomization, participants will undergo graded exercise testing, functional performance assessments, and questionnaires. Participants assigned to the exercise groups will complete supervised training for 12 weeks. The alternating concentric-eccentric group will also undergo an eccentric exercise familiarization period before the formal training program. Participants in the usual-care group will continue routine care with self-regulated exercise intensity for 12 weeks. After the intervention, graded exercise testing, functional assessments, and questionnaires will be repeated.
The study will evaluate changes in functional performance, exercise capacity, muscle function, symptoms, and quality of life to determine whether alternating concentric-eccentric HIIT provides additional benefits compared with conventional concentric HIIT and usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized in parallel to one of three groups: alternating concentric-eccentric high-intensity interval training, concentric high-intensity interval training, or usual care.
| Arm | Type | Receives |
|---|---|---|
| Alternating Concentric-Eccentric HIIT | Experimental | Behavioral: Alternating Concentric-Eccentric High-Intensity Interval TrainingParticipants will undergo a 2-week eccentric cycling familiarization period followed by 12 weeks of high-intensity interval training. During the high-intensity intervals, concentric cycling will be performed at 80% of peak work rate, while the recovery intervals will use eccentric cycling at the same external workload. |
| Concentric HIIT | Active comparator | Behavioral: Concentric High-Intensity Interval TrainingParticipants will undergo 12 weeks of high-intensity interval concentric cycling training. High-intensity intervals will be performed at 80% of peak work rate, with recovery intervals performed concentrically at 40% of peak work rate. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants will continue usual care with self-regulated exercise intensity for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able and willing to provide written informed consent. Adults aged 18 years or older with chronic respiratory disease. Have participated in a pulmonary rehabilitation program for more than 3 months. For participants with an implanted cardioverter-defibrillator (ICD), the programmed maximum heart rate must be higher than the target heart rate used during exercise training.
- Considered medically suitable for exercise training by a specialist physician.
Key exclusion criteria (3 listed)
- Presence of a tracheostomy. Use of long-term home oxygen therapy or home mechanical ventilation. Severe left-sided heart failure classified as New York Heart Association (NYHA) functional class III or IV.
- Diagnosis of a neuromuscular disease. Acute exacerbation of chronic obstructive pulmonary disease (COPD) within the previous 3 months.
- Unable to complete or cooperate with cardiopulmonary exercise testing.
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 |
|---|---|---|
| Alternating Concentric-Eccentric High-Intensity Interval TrainingAlso: Alternating Concentric-Eccentric HIITParticipants will complete a 2-week eccentric cycling familiarization period followed by 12 weeks of supervised high-intensity interval training, performed twice weekly. Each formal training session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of eccentric cycling performed at the same external workload as the high-intensity concentric interval. | Behavioural | Alternating Concentric-Eccentric HIIT |
| Concentric High-Intensity Interval TrainingAlso: Concentric HIITParticipants will complete 12 weeks of supervised high-intensity interval concentric cycling training, performed twice weekly. Each session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of concentric cycling at 40% Wpeak. | Behavioural | Concentric HIIT |
| Usual CareParticipants will continue usual care with self-regulated exercise intensity for 12 weeks. No structured high-intensity interval or eccentric cycling training will be provided as part of the study intervention. | Behavioural | Usual Care |
Primary outcome
Change in 6-Minute Walk Distance
Time frame: Baseline and 12 weeks
The 6-minute walk test will be used to assess functional exercise capacity. The distance walked in 6 minutes on a 30-meter indoor corridor will be recorded in meters. Change from baseline to post-intervention will be compared among the three study groups.
Change in Timed Up and Go Test
Time frame: Baseline and 12 weeks
The Timed Up and Go test will be used to assess functional mobility, balance, and gait performance. Participants will stand from a chair, walk 3 meters, turn, return to the chair, and sit down. Three trials will be performed, and the fastest completion time in seconds will be used for analysis.
Change in Stair Climbing Performance
Time frame: Baseline and 12 weeks
Stair climbing performance will be assessed using a fixed number of stairs to evaluate lower-extremity strength, balance, agility, and functional performance. Completion time will be recorded in seconds.
1 secondary outcome
Change in St. George's Respiratory Questionnaire Score
Time frame: Baseline and after 12 weeks of formal training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 41290215Chao KY, Liu WL, Hsu HW, Chen HC, Lim AY, Wang JS. Eccentric cycling for chronic respiratory disease: Does helmet ventilation add value? A randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251404870. doi: 10.1177/14799731251404870. Epub 2025 Nov 25.
- Background: PubMed 34799753Inostroza M, Valdes O, Tapia G, Nunez O, Kompen MJ, Nosaka K, Penailillo L. Effects of eccentric vs concentric cycling training on patients with moderate COPD. Eur J Appl Physiol. 2022 Feb;122(2):489-502. doi: 10.1007/s00421-021-04850-x. Epub 2021 Nov 20.
- Background: PubMed 26243014Milanovic Z, Sporis G, Weston M. Effectiveness of High-Intensity Interval Training (HIT) and Continuous Endurance Training for VO2max Improvements: A Systematic Review and Meta-Analysis of Controlled Trials. Sports Med. 2015 Oct;45(10):1469-81. doi: 10.1007/s40279-015-0365-0.
- Background: PubMed 32362839Harrison AJ, Burdon CA, Groeller H, Peoples GE. The Acute Physiological Responses of Eccentric Cycling During the Recovery Periods of a High Intensity Concentric Cycling Interval Session. Front Physiol. 2020 Apr 17;11:336. doi: 10.3389/fphys.2020.00336. eCollection 2020.
- Background: PubMed 37716519Pancera S, Lopomo NF, Porta R, Sanniti A, Buraschi R, Bianchi LNC. Effects of Combined Endurance and Resistance Eccentric Training on Muscle Function and Functional Performance in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Mar;105(3):470-479. doi: 10.1016/j.apmr.2023.09.004. Epub 2023 Sep 15.
- 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.
Hui-Wen Hsu, M.S. principal investigator
Fu Jen Catholic 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 Alternating Concentric-Eccentric High-Intensity Interval Training and Concentric High-Intensity Interval Training in people with Chronic Respiratory Disease and Chronic Obstructive Pulmonary Disease, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
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 3 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: opening soon, as of the sponsor's last update on 9 Oct 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Wen Hsu, M.S. (+886-2-8512-8888 ext. 23426, 76wwocat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-Minute Walk Distance (time frame: Baseline and 12 weeks). 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?
On the ClinicalTrials.gov record for NCT07867535, which also lists 5 linked publications.
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 9 Oct 2026.