Revision Total Hip ArthroplastyStrongHipNCT05657054
Exercise Intervention Targeting Hip Strengthening Compared to Usual Care in Patients Undergoing Revision Hip Replacement
A study testing Exercise Intervention Targeting Hip Strengthening in people with Revision Total Hip Arthroplasty, run by University of Aarhus at 9 sites in Denmark.
Trial summary
There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Total Hip Arthroplasty
- What is being tested?
- Exercise Intervention Targeting Hip Strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 9 sitesDenmark
- Study dates
- 25 Nov 2022to 1 Dec 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
- Patients undergoing first revision THR
- Age ≥ 18 years
- Motivated to participate in an exercise program for 16 weeks
- Provided informed consent to participate
- Patients who has the cup and/or stem replaced or a combination of liner and caput replaced
- Patients who can be baseline tested (chair stand test, stair climb test, 40m walking test)
Who cannot join
- Dependency of wheelchair
- Preplanned other lower limb surgery within 12 months
- Body Mass Index (BMI) score > 40
- Currently undergoing cancer treatment, e.g. chemo-, immuno-, or radiotherapy.
- Comorbidities that prevent exercise
- Inadequacy in written and spoken Danish
- Mentally unable to participate
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Aarhus University
Aarhus, 8000
Aarhus University Hospital
Aarhus N, 8200
Bispebjerg Hospital
Copenhagen, 2400
University Hospital, Gentofte, Copenhagen
Hellerup, 2900
Gødstrup Hospital
Herning, 7400
Odense University Hospital
Odense, 5000
Regional Hospital Silkeborg
Silkeborg, 9640
Vejle Hospital
Vejle, 7100
Regional Hospital Viborg
Viborg, 8800
About this study
Official title: Effect of an Exercise Intervention Targeting Hip Strengthening in Patients Undergoing Revision Total Hip Replacement - a Multicenter, Randomized Controlled Trial (The Strong Hip Trial)
There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Further, patients undergoing revision THR achieve worse clinical outcomes on hip pain and function compared to patients undergoing primary THR. The primary aim of this randomized controlled trial is to compare the clinical effectiveness of a partly tele-delivered exercise intervention targeting hip strengthening with the standard community-based rehabilitation (usual care) in patients undergoing revision THR. The investigators will test the hypothesis that the exercise intervention targeting hip strengthening is superior to standard community-based rehabilitation in improving physical function measured with the 30-second Chair Stand Test at 16-week follow-up.
Read the detailed description
There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Revision THR is one of the more technically challenging orthopedic surgeries and patients undergoing revision THR report improvements in pain and function. Nevertheless, patients undergoing revision THR achieve worse clinical outcomes on hip pain and function compared to patients undergoing primary THR. This calls for research exploring different rehabilitation approaches, in order to improve clinical outcomes for patients after revision THR.
This study aims to compare the clinical effectiveness of a partly tele-delivered exercise intervention targeting hip strengthening with the standard community-based rehabilitation (usual care) in patients undergoing revision THR.
This randomized, controlled, assessor-blinded trial is a multicenter trial involving hospitals and municipality rehabilitation centers across Denmark. Eligible patients undergoing revision THR will be randomized into two groups: A partly remotely-delivered hip strengthening rehabilitation intervention (strength group) or usual care (control group).
The exercise intervention targeting hip strengthening will partly follow the Neuromuscular Exercise (NEMEX) program as described by Eva Ageberg et al., and the intervention is further modified based on expert opinion from patients' experience with rehabilitation from a prior qualitative study. Usual care consists of rehabilitation in the municipalities, where it is up to the individual physiotherapist and the municipality to organize the rehabilitation, which is why both type, content, and duration may vary.
The primary outcome will be change in functional performance measured by the 30-second Chair Stand Test. Outcomes will be measured at baseline, after 16 weeks of intervention, and at 12-month follow-up.
The investigators hypothesize that the exercise intervention targeting hip strengthening is superior to usual care in improving physical function measured with the 30-second Chair Stand Test at 16-week follow-up.
- Conditions
- Revision Total Hip Arthroplasty
- Being tested
- Exercise Intervention Targeting Hip Strengthening, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Intervention Targeting Hip StrengtheningOther
An initial 16-week exercise intervention of 45 minutes of training 3 times a week in the patient's own home or at a rehabilitation center. Patients will be instructed by a physiotherapist during the first 3 sessions, in order to be able to perform the exercises at home. Subsequently, there are physiotherapist-supervised sessions once every second week. The delivery of the supervised sessions is based on the patient's preferences, either by physical attendance or remotely in the patient's home. The intervention will consist of 4 exercises adapted from the NEMEX program targeting lower extremity muscle strength, stability, postural function, and postural orientation. Progression is made when an exercise is performed with good sensorimotor control and good performance quality and with minimal exertion and adequate movement control. Progression is primarily provided by 3 levels of difficulty and secondly by varying the number of repetitions or where possible, by increasing the weight load.
Usual CareOther
The intervention will consist of a rehabilitation intervention corresponding to standard care in the participating municipalities (i.e. content and duration of intervention). The intervention will be delivered individually or as group training, based on a clinical assessment of the individual patients' needs. The intervention can be supported by home-based exercises following instruction from a physiotherapist, supplemented by the provision of written information or access to a virtual training program. The intervention occurs in either the rehabilitation center's gym or the patient's home. The training sessions may consist of some of the following parameters: Strength training, stretching, functional training e.g. walking and stair climbing, stability training, balance training, endurance training, and gait correction.
| Study group | Role | What they receive |
|---|---|---|
| Strength group | Experimental | Group 1 Receives: Other: Exercise Intervention Targeting Hip Strengthening |
| Control group | Active comparator | Group 2 Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional performance measured by the 30-seconds chair stand test
The 30-second chair stand test is a valid and reliable measure of lower-extremity muscle strength evaluating sit-to-stand function, which is limited in people undergoing hip replacement.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Secondary outcomes (12)
Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale
The HOOS pain subscale is a 10-item patient-reported outcome measure designed to assess hip pain in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better pain status.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Change in the HOOS symptoms subscale
The HOOS symptom subscale is a five-item patient-reported outcome measure designed to assess other hip symptoms in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better symptom status.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Change in the HOOS activities of daily living (ADL) function subscale
The HOOS ADL function subscale is a 17-item patient-reported outcome measure designed to assess ADL function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better ADL function status.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Change in the HOOS quality-of-life subscale
The HOOS quality-of-life subscale is a four-item patient-reported outcome measure designed to assess hip-related quality-of-life in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better quality-of-life status.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Change in the HOOS sports and recreation subscale
The HOOS sports and recreation subscale is a four-item patient-reported outcome measure designed to assess sports and recreation function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better sports and recreation status.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Change in 40m Fast-Paced Walk Test (40m-FPWT)
The 40m-FPWT is a physical function test designed to measure the ability to walk quickly over short distances and is measured as the time it takes to complete a 40 m course at a fast walking pace.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Change in 9-step Timed Stair Climb Test (9-step TSCT)
The 9-step TSCT is a physical function test designed to measure lower body strength and balance as well as ascending and descending stair activity and is measured as the time it takes to ascend and descend a 9-step stair.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Change in leg extension muscle power (watt/kg body weight)
The Nottingham Power Rig (NPR) is used to measure leg extensor muscle power. The NPR measures the power output in total watt and watt pr. bodyweight in kilograms from a seated push on a flat pedal which is transmitted by a lever and chain to spin a flywheel. The NPR is a safe and reliable method to measure explosive knee extensor muscle power and has been validated as a clinically important measure of muscle function in elderly individuals.
Measured: Measured at baseline, 16-week, and 12-month follow-up.
Global Perceived Effect (GPE)
The GPE will be used as a measure of patient-rated recovery and will be assessed for three domains; pain, activities of daily living, and quality of life rated on a 7-point Likert scale ranging from 'very bad' (worst) to 'very good' (best)
Measured: Measured at 16-week and 12-month follow-up.
AE (Adverse Events) & Serious Adverse Events (SAE)
Continuous registration of health issues and injuries. The events will be monitored by the physiotherapists supervising the exercise sessions. Further, patients will be asked at 4- and 12-month follow-ups about potential AE and SAE using open-probe questions.
Measured: Registered throughout the 12-month study period.
Adherence to the 16-week intervention
High adherence is defined as attendance in ≥75% of the exercise sessions.
Measured: Registered throughout the 16-week initial intervention.
Drop-outs
Number of drop-out from the interventions.
Measured: Registered throughout the 12-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start25 Nov 2022
- Primary completion3 Dec 2024
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Revision Total Hip ArthroplastyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Vejle Hospital, Regionshospitalet Silkeborg, Gødstrup Hospital, Viborg Regional Hospital, Odense University Hospital, Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen
- Responsible party
- Sponsor
- Investigators
- Martin B Stisen, MSc, Principal investigator, Aarhus University Hospital and Aarhus UniversityInger Mechlenburg, Prof., Study director, Aarhus University Hospital and Aarhus UniversityAlma B Pedersen, Prof., Study director, Aarhus University Hospital and Aarhus UniversityTroels Kjeldsen, MSc, Study director, Aarhus University Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657054
- Sponsor's protocol ID
- StrongHip
- Acronym
- StrongHip
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.
Publications
Stisen MG, Pedersen AB, Kjeldsen T, Foldager FN, Lamm M, Assenholt A, Hvidberg KL, Rasmussen MK, Aalund PK, Frandsen CF, Holsgaard-Larsen A, Haubro MH, Bieler T, Overgaard S, Beck T, Ingwersen KG, Parner ET, Mechlenburg I. Hip strengthening exercise compared to standard rehabilitation after revision hip replacement: a multicenter randomized controlled trial. Ann Phys Rehabil Med. 2026 May;69(4):102076. doi: 10.1016/j.rehab.2025.102076. Epub 2026 Jan 13.
PubMed 41534141Stisen MB, Pedersen AB, Kjeldsen T, Mechlenburg I. Effect of an exercise intervention targeting hip strengthening in patients undergoing revision total hip replacement-A study protocol for a multicenter randomized controlled trial. Physiother Res Int. 2024 Jul;29(3):e2101. doi: 10.1002/pri.2101.
PubMed 38859640
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
- Effect of an Exercise Intervention Targeting Hip Strengthening in Patients Undergoing Revision Total Hip Replacement - a Multicenter, Randomized Controlled Trial (The Strong Hip Trial)
- ClinicalTrials.gov ID
- NCT05657054
- Acronym / sponsor ID
- StrongHip / StrongHip
- Conditions
- Revision Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Vejle Hospital, Regionshospitalet Silkeborg, Gødstrup Hospital, Viborg Regional Hospital, Odense University Hospital, Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Dec 2022 (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.
There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Further, patients undergoing revision THR achieve worse clinical outcomes on hip pain and function compared to patients undergoing primary THR. The primary aim of this randomized controlled trial is to compare the clinical effectiveness of a partly tele-delivered exercise intervention targeting hip strengthening with the standard community-based rehabilitation (usual care) in patients undergoing revision THR. The investigators will test the hypothesis that the exercise intervention targeting hip strengthening is superior to standard community-based rehabilitation in improving physical function measured with the 30-second Chair Stand Test at 16-week follow-up.
Detailed description
There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Revision THR is one of the more technically challenging orthopedic surgeries and patients undergoing revision THR report improvements in pain and function. Nevertheless, patients undergoing revision THR achieve worse clinical outcomes on hip pain and function compared to patients undergoing primary THR. This calls for research exploring different rehabilitation approaches, in order to improve clinical outcomes for patients after revision THR.
This study aims to compare the clinical effectiveness of a partly tele-delivered exercise intervention targeting hip strengthening with the standard community-based rehabilitation (usual care) in patients undergoing revision THR.
This randomized, controlled, assessor-blinded trial is a multicenter trial involving hospitals and municipality rehabilitation centers across Denmark. Eligible patients undergoing revision THR will be randomized into two groups: A partly remotely-delivered hip strengthening rehabilitation intervention (strength group) or usual care (control group).
The exercise intervention targeting hip strengthening will partly follow the Neuromuscular Exercise (NEMEX) program as described by Eva Ageberg et al., and the intervention is further modified based on expert opinion from patients' experience with rehabilitation from a prior qualitative study. Usual care consists of rehabilitation in the municipalities, where it is up to the individual physiotherapist and the municipality to organize the rehabilitation, which is why both type, content, and duration may vary.
The primary outcome will be change in functional performance measured by the 30-second Chair Stand Test. Outcomes will be measured at baseline, after 16 weeks of intervention, and at 12-month follow-up.
The investigators hypothesize that the exercise intervention targeting hip strengthening is superior to usual care in improving physical function measured with the 30-second Chair Stand Test at 16-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength group | Experimental | Other: Exercise Intervention Targeting Hip StrengtheningGroup 1 |
| Control group | Active comparator | Other: Usual CareGroup 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing first revision THR
- Age ≥ 18 years
- Motivated to participate in an exercise program for 16 weeks
- Provided informed consent to participate
- Patients who has the cup and/or stem replaced or a combination of liner and caput replaced
Key exclusion criteria (7 listed)
- Dependency of wheelchair
- Preplanned other lower limb surgery within 12 months
- Body Mass Index (BMI) score > 40
- Currently undergoing cancer treatment, e.g. chemo-, immuno-, or radiotherapy.
- Comorbidities that prevent exercise
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 |
|---|---|---|
| Exercise Intervention Targeting Hip StrengtheningAn initial 16-week exercise intervention of 45 minutes of training 3 times a week in the patient's own home or at a rehabilitation center. Patients will be instructed by a physiotherapist during the first 3 sessions, in order to be able to perform the exercises at home. Subsequently, there are physiotherapist-supervised sessions once every second week. The delivery of the supervised sessions is based on the patient's preferences, either by physical attendance or remotely in the patient's home. The intervention will consist of 4 exercises adapted from the NEMEX program targeting lower extremity muscle strength, stability, postural function, and postural orientation. Progression is made when an exercise is performed with good sensorimotor control and good performance quality and with minimal exertion and adequate movement control. Progression is primarily provided by 3 levels of difficulty and secondly by varying the number of repetitions or where possible, by increasing the weight load. | Other | Strength group |
| Usual CareThe intervention will consist of a rehabilitation intervention corresponding to standard care in the participating municipalities (i.e. content and duration of intervention). The intervention will be delivered individually or as group training, based on a clinical assessment of the individual patients' needs. The intervention can be supported by home-based exercises following instruction from a physiotherapist, supplemented by the provision of written information or access to a virtual training program. The intervention occurs in either the rehabilitation center's gym or the patient's home. The training sessions may consist of some of the following parameters: Strength training, stretching, functional training e.g. walking and stair climbing, stability training, balance training, endurance training, and gait correction. | Other | Control group |
Primary outcome
Change in functional performance measured by the 30-seconds chair stand test
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
The 30-second chair stand test is a valid and reliable measure of lower-extremity muscle strength evaluating sit-to-stand function, which is limited in people undergoing hip replacement.
12 secondary outcomes
Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
Change in the HOOS symptoms subscale
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
Change in the HOOS activities of daily living (ADL) function subscale
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
Change in the HOOS quality-of-life subscale
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
Change in the HOOS sports and recreation subscale
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
Change in 40m Fast-Paced Walk Test (40m-FPWT)
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
Change in 9-step Timed Stair Climb Test (9-step TSCT)
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
Change in leg extension muscle power (watt/kg body weight)
Time frame: Measured at baseline, 16-week, and 12-month follow-up.
Global Perceived Effect (GPE)
Time frame: Measured at 16-week and 12-month follow-up.
AE (Adverse Events) & Serious Adverse Events (SAE)
Time frame: Registered throughout the 12-month study period.
Adherence to the 16-week intervention
Time frame: Registered throughout the 16-week initial intervention.
Drop-outs
Time frame: Registered throughout the 12-month study period.
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 26 Jan 2026.
- Derived from this study: PubMed 41534141Stisen MG, Pedersen AB, Kjeldsen T, Foldager FN, Lamm M, Assenholt A, Hvidberg KL, Rasmussen MK, Aalund PK, Frandsen CF, Holsgaard-Larsen A, Haubro MH, Bieler T, Overgaard S, Beck T, Ingwersen KG, Parner ET, Mechlenburg I. Hip strengthening exercise compared to standard rehabilitation after revision hip replacement: a multicenter randomized controlled trial. Ann Phys Rehabil Med. 2026 May;69(4):102076. doi: 10.1016/j.rehab.2025.102076. Epub 2026 Jan 13.
- Derived from this study: PubMed 38859640Stisen MB, Pedersen AB, Kjeldsen T, Mechlenburg I. Effect of an exercise intervention targeting hip strengthening in patients undergoing revision total hip replacement-A study protocol for a multicenter randomized controlled trial. Physiother Res Int. 2024 Jul;29(3):e2101. doi: 10.1002/pri.2101.
- Individual participant dataSharing planned: Yes. Anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.
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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.
Martin B Stisen, MSc principal investigator
Aarhus University Hospital and Aarhus University
Inger Mechlenburg, Prof. study director
Aarhus University Hospital and Aarhus University
Alma B Pedersen, Prof. study director
Aarhus University Hospital and Aarhus University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention Targeting Hip Strengthening in people with Revision Total Hip Arthroplasty, run by University of Aarhus at 9 sites in Denmark.
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 7 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: under way, not looking for participants, 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 9 sites in Denmark. 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?
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 in functional performance measured by the 30-seconds chair stand test (time frame: Measured at baseline, 16-week, and 12-month follow-up.). 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 NCT05657054, which also lists 2 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 26 Jan 2026.