MyositisHI-STIMNCT04486261
High-intensity Strength Training in Myositis
A study testing High-intensity strength training in people with Myositis and Dermatomyositis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36). The study is designed as a parallel group randomised controlled trial with an intervention group and a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myositis, Dermatomyositis, Polymyositis
- What is being tested?
- High-intensity strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Aug 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilling the criteria for myositis by EULAR/ACR (Bottai et al., 2017; Lundberg et al., 2017)
- ≤ 5 mg/day Prednisolone
- Stable dosage of immunosuppressive treatment for at least 1 months prior to inclusion in the study
- Myositis diagnosis at least 6 months prior to inclusion in the study
Who cannot join
- Patients with sporadic inclusion body myositis and overlap myositis (myositis combined with another autoimmune rheumatic diseases, except Sjögren's Syndrome)
- Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic > 160mmHg, diastolic > 100mmHg), severe knee/hip arthritis)
- Alcohol- and/or drug abuse. Defined by the guidelines issued by The Danish Health Authority
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-intensity Strength Training in Patients With Idiopathic Inflammatory Myopathies: Changes in Quality of Life, Muscle Strength, Function and Myocellular Parameters
This study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36). The study is designed as a parallel group randomised controlled trial with an intervention group and a control group.
Read the detailed description
Overall aim:
To investigate the effect of high-intensity strength training on quality of life, muscle strength, physical function, and disease activity in patients with myositis
Study design:
60 myositis patients will be included in a 16-week high-intensity strength training study. Patients will be randomly allocated into 2 groups (strength training and control) in a 1:1 ratio.
User involvement:
Myositis patients has been recruited to a patient advisory board. The advisory board's objective is to give patient-oriented project feedback, thus improving the overall research project.
Intervention:
Two training session per week for 16 weeks. Sessions consists of 3 sets of each exercise corresponding to 10 RM. Training progression will be accounted for and training loads will be evaluated weekly. The training protocol will be a full-body protocol, i.e. all major muscle groups will be engaged during each training session.
Outcomes:
The primary outcome is the Physical Component Summary Measure from the quality of life questionnaire (SF-36). Secondary outcomes include strength measures, functional tests, disease activity measures, questionnaires (e.g. International physical activity questionnaire), DEXA whole body scans, blood samples and muscle biopsies.
- Being tested
- High-intensity strength training
- Medical subject headings
- Myositis, Dermatomyositis, Polymyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity strength trainingOther
Also called High-intensity resistance training
The high-intensity strength training protocol will consist of 2 training sessions per week. The first two weeks will be familiarisation training, where each exercise will be performed in three sets of 10 repetitions at an intensity of 15 repetitions maximum (RM). At week three each session will consist of 3 sets of each exercise corresponding to 10 RM, which will be kept for the remaining part of training intervention. The weights for each exercise will be adjusted throughout the intervention period, so the training load will correspond to 10 RM for each exercise in the entire intervention period.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity strength training | Experimental | 16 weeks of high-intensity strength training two times per week.
Participants will receive the usual care in accordance to myositis (various DMARDs, different from patient to patient)
Interventions:
Other: high-intensity strength training Drug: Usual care Receives: Other: High-intensity strength training |
| Control | No intervention | Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient). Intervention: Drug: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (health survey (SF-36) subscale: Physical Component Summary)
Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Component Summary. The scale ranges from 0 to 100 where 100 is the highest score.
Measured: 16 weeks
Secondary outcomes (23)
Leg power
Power rig
Measured: 16 weeks
Handgrip strength
Measured by a handheld dynamometer
Measured: 16 weeks
Functional Index 3
A test of muscle strength in a series of muscles, carried out by the physician or physiotherapist
Measured: 16 weeks
30 seconds chair rise
Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.
Measured: 16 weeks
Timed up-and-go
Participants are instructed to rise from a chair walk 3 m forward, pass a marking and return to the chair and sit down as fast as possible
Measured: 16 weeks
2-minute walk test
A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.
Measured: 16 weeks
Balance
Short physical performance battery - balance part
Measured: 16 weeks
Whole-body, appendicular and lower-limb lean mass
Measured by Dual-energy X-ray absorptiometry
Measured: 16 weeks
Fat-free mass, body fat and total mass
Measured by bioimpedance
Measured: 16 weeks
Physician Global Activity
Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity
Measured: 16 weeks
Patient Global Activity
Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.
Measured: 16 weeks
Extra-muscular Disease Activity
An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and a 0-10 cm scale, where the higher score indicates higher disease activity.
Measured: 16 weeks
Manual muscle test 8
A test of muscle strength in a series of muscles, carried out by the physician
Measured: 16 weeks
Health Assessment Questionnaire (HAQ)
HAQ is a questionnaire to evaluate patient reported disability. It has 8 categories with a range of questions. Each question is scored from 0 to 3 where 0 is no disability and 3 is unable to do.
Measured: 16 weeks
Physician Global assessment of disease damage
Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.
Measured: 16 weeks
Patient Global assessment of disease damage
Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.
Measured: 16 weeks
Medical history
Questionnaire:
Basic cardiovascular questionnaire concerning medical conditions, current medication, heart symptoms and smoking habits
Measured: 16 weeks
Self-perceived physical activity levels
International Physical Activity Questionnaire - long
Measured: 16 weeks
Quality of life (health survey (SF-36) subscale: Mental component summary)
Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Mental Component Summary. The scale ranges from 0 to 100 where 100 is the highest score.
Measured: 16 weeks
Body mass index (BMI)
Weight will be measured by scale (kg). Height will be measured by measuring (m). BMI will be derived from weight and height (kg/m^2)
Measured: 16 weeks
Systolic and diastolic blood pressure
Measured by blood pressure monitor
Measured: 16 weeks
Blood samples (analysis of markers of af disease activity)
Plasma analysis: lipid profile, HbA1c, troponins, NT-proBNP, creatine kinase
Measured: 16 weeks
Electrocardiography (ECG)
Standard 12-lead ECG at 25 mm/s is recorded and analyzed according to standard published criteria (48-50). According to the Minnesota coding the PQ-interval is measured and presence of 1st, 2nd (including Mobitz type 1 and 2), and 3rd degree of AV block are noted. Additional measures will include: P-wave duration (≥ 2.5 mm in any of leads II, III, aVF), QRS duration (≥ 120 ms in any of leads I, II, III, aVL, aVF), QTc duration (> 450 ms), atrial fibrillation and flutter.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start30 Aug 2021
- Primary completion1 Mar 2022
- Study completion1 Jan 2023
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 MyositisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital
- Responsible party
- Principal investigator, Louise Pyndt Diederichsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Louise Pyndt Diederichsen, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486261
- Sponsor's protocol ID
- MCT16072020
- Acronym
- HI-STIM
- Status last verified
- Apr 2024
- First submitted
- 17 Jul 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to GDPR-regulations IPD will not be available.
Publications
Bottai M, Tjarnlund A, Santoni G, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinka M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Wook Song Y, Vencovsky J, Ytterberg SR, Miller FW, Rider LG, Lundberg IE; International Myositis Classification Criteria Project consortium, the Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups: a methodology report. RMD Open. 2017 Nov 14;3(2):e000507. doi: 10.1136/rmdopen-2017-000507. eCollection 2017.
PubMed 29177080Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project Consortium, the Euromyositis Register, and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their Major Subgroups. Arthritis Rheumatol. 2017 Dec;69(12):2271-2282. doi: 10.1002/art.40320. Epub 2017 Oct 27.
PubMed 29106061Jensen KY, Aagaard P, Suetta C, Nielsen JL, Bech RD, Schroder HD, Christensen J, Simonsen C, Diederichsen LP. High-intensity resistance training in patients with myositis - 1-year follow-up on a randomised controlled trial. Rheumatol Int. 2025 Apr 16;45(5):104. doi: 10.1007/s00296-025-05858-8.
PubMed 40237840Jensen KY, Aagaard P, Suetta C, Nielsen JL, Bech RD, Schroder HD, Christensen J, Simonsen C, Diederichsen LP. High-intensity resistance training improves quality of life, muscle endurance and strength in patients with myositis: a randomised controlled trial. Rheumatol Int. 2024 Oct;44(10):1909-1921. doi: 10.1007/s00296-024-05698-y. Epub 2024 Aug 27.
PubMed 39192022Jensen KY, Aagaard P, Schroder HD, Suetta C, Nielsen JL, Boyle E, Diederichsen LP. High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol. BMJ Open. 2021 Jun 25;11(6):e043793. doi: 10.1136/bmjopen-2020-043793.
PubMed 34172544
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Strength Training in Patients With Idiopathic Inflammatory Myopathies: Changes in Quality of Life, Muscle Strength, Function and Myocellular Parameters
- ClinicalTrials.gov ID
- NCT04486261
- Acronym / sponsor ID
- HI-STIM / MCT16072020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 24 Jul 2020 (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 study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36). The study is designed as a parallel group randomised controlled trial with an intervention group and a control group.
Detailed description
Overall aim:
To investigate the effect of high-intensity strength training on quality of life, muscle strength, physical function, and disease activity in patients with myositis
Study design:
60 myositis patients will be included in a 16-week high-intensity strength training study. Patients will be randomly allocated into 2 groups (strength training and control) in a 1:1 ratio.
User involvement:
Myositis patients has been recruited to a patient advisory board. The advisory board's objective is to give patient-oriented project feedback, thus improving the overall research project.
Intervention:
Two training session per week for 16 weeks. Sessions consists of 3 sets of each exercise corresponding to 10 RM. Training progression will be accounted for and training loads will be evaluated weekly. The training protocol will be a full-body protocol, i.e. all major muscle groups will be engaged during each training session.
Outcomes:
The primary outcome is the Physical Component Summary Measure from the quality of life questionnaire (SF-36). Secondary outcomes include strength measures, functional tests, disease activity measures, questionnaires (e.g. International physical activity questionnaire), DEXA whole body scans, blood samples and muscle biopsies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity strength training | Experimental | Other: High-intensity strength training16 weeks of high-intensity strength training two times per week. Participants will receive the usual care in accordance to myositis (various DMARDs, different from patient to patient) Interventions: Other: high-intensity strength training Drug: Usual care |
| Control | No intervention | –Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient). Intervention: Drug: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fulfilling the criteria for myositis by EULAR/ACR (Bottai et al., 2017; Lundberg et al., 2017)
- ≤ 5 mg/day Prednisolone
- Stable dosage of immunosuppressive treatment for at least 1 months prior to inclusion in the study
- Myositis diagnosis at least 6 months prior to inclusion in the study
Key exclusion criteria (3 listed)
- Patients with sporadic inclusion body myositis and overlap myositis (myositis combined with another autoimmune rheumatic diseases, except Sjögren's Syndrome)
- Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic > 160mmHg, diastolic > 100mmHg), severe knee/hip arthritis)
- Alcohol- and/or drug abuse. Defined by the guidelines issued by The Danish Health Authority
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 |
|---|---|---|
| High-intensity strength trainingAlso: High-intensity resistance trainingThe high-intensity strength training protocol will consist of 2 training sessions per week. The first two weeks will be familiarisation training, where each exercise will be performed in three sets of 10 repetitions at an intensity of 15 repetitions maximum (RM). At week three each session will consist of 3 sets of each exercise corresponding to 10 RM, which will be kept for the remaining part of training intervention. The weights for each exercise will be adjusted throughout the intervention period, so the training load will correspond to 10 RM for each exercise in the entire intervention period. | Other | High-intensity strength training |
Primary outcome
Quality of life (health survey (SF-36) subscale: Physical Component Summary)
Time frame: 16 weeks
Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Component Summary. The scale ranges from 0 to 100 where 100 is the highest score.
23 secondary outcomes
Leg power
Time frame: 16 weeks
Handgrip strength
Time frame: 16 weeks
Functional Index 3
Time frame: 16 weeks
30 seconds chair rise
Time frame: 16 weeks
Timed up-and-go
Time frame: 16 weeks
2-minute walk test
Time frame: 16 weeks
Balance
Time frame: 16 weeks
Whole-body, appendicular and lower-limb lean mass
Time frame: 16 weeks
Fat-free mass, body fat and total mass
Time frame: 16 weeks
Physician Global Activity
Time frame: 16 weeks
Patient Global Activity
Time frame: 16 weeks
Extra-muscular Disease Activity
Time frame: 16 weeks
Manual muscle test 8
Time frame: 16 weeks
Health Assessment Questionnaire (HAQ)
Time frame: 16 weeks
Physician Global assessment of disease damage
Time frame: 16 weeks
Patient Global assessment of disease damage
Time frame: 16 weeks
Medical history
Time frame: 16 weeks
Self-perceived physical activity levels
Time frame: 16 weeks
Quality of life (health survey (SF-36) subscale: Mental component summary)
Time frame: 16 weeks
Body mass index (BMI)
Time frame: 16 weeks
Systolic and diastolic blood pressure
Time frame: 16 weeks
Blood samples (analysis of markers of af disease activity)
Time frame: 16 weeks
Electrocardiography (ECG)
Time frame: 16 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 10 Apr 2024.
- Background: PubMed 29177080Bottai M, Tjarnlund A, Santoni G, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinka M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Wook Song Y, Vencovsky J, Ytterberg SR, Miller FW, Rider LG, Lundberg IE; International Myositis Classification Criteria Project consortium, the Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups: a methodology report. RMD Open. 2017 Nov 14;3(2):e000507. doi: 10.1136/rmdopen-2017-000507. eCollection 2017.
- Background: PubMed 29106061Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project Consortium, the Euromyositis Register, and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their Major Subgroups. Arthritis Rheumatol. 2017 Dec;69(12):2271-2282. doi: 10.1002/art.40320. Epub 2017 Oct 27.
- Derived from this study: PubMed 40237840Jensen KY, Aagaard P, Suetta C, Nielsen JL, Bech RD, Schroder HD, Christensen J, Simonsen C, Diederichsen LP. High-intensity resistance training in patients with myositis - 1-year follow-up on a randomised controlled trial. Rheumatol Int. 2025 Apr 16;45(5):104. doi: 10.1007/s00296-025-05858-8.
- Derived from this study: PubMed 39192022Jensen KY, Aagaard P, Suetta C, Nielsen JL, Bech RD, Schroder HD, Christensen J, Simonsen C, Diederichsen LP. High-intensity resistance training improves quality of life, muscle endurance and strength in patients with myositis: a randomised controlled trial. Rheumatol Int. 2024 Oct;44(10):1909-1921. doi: 10.1007/s00296-024-05698-y. Epub 2024 Aug 27.
- Derived from this study: PubMed 34172544Jensen KY, Aagaard P, Schroder HD, Suetta C, Nielsen JL, Boyle E, Diederichsen LP. High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol. BMJ Open. 2021 Jun 25;11(6):e043793. doi: 10.1136/bmjopen-2020-043793.
- Individual participant dataSharing planned: No. Due to GDPR-regulations IPD will not be available.
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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.
Louise Pyndt Diederichsen, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity strength training in people with Myositis and Dermatomyositis, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 4 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: finished, as of the sponsor's last update on 10 Apr 2024. 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 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?
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?
Quality of life (health survey (SF-36) subscale: Physical Component Summary) (time frame: 16 weeks). 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 NCT04486261, 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 10 Apr 2024.