NCT04486261 (HI-STIM) is a NA clinical trial of High-intensity strength training in Myositis, sponsored by Rigshospitalet, Denmark.

Who is sponsoring NCT04486261?

NCT04486261 is sponsored by Rigshospitalet, Denmark.

What drugs are being tested in NCT04486261?

Interventions in NCT04486261: High-intensity strength training.

What condition does NCT04486261 study?

NCT04486261 studies Myositis, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy.

Is NCT04486261 still recruiting?

NCT04486261 is currently completed. Last updated 10 April 2024.

Last reviewed 2024-04-10 · How we verify

NCT04486261: HI-STIM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

High-intensity Strength Training in Myositis

Completed NA Last updated 10 April 2024

What this trial tests

NA trial testing High-intensity strength training in Myositis in 34 participants. Completed in 1 January 2023.

Timeline

30 August 2021

Primary endpoint
1 March 2022

1 January 2023

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	34
Start date	30 August 2021
Primary completion	1 March 2022
Estimated completion	1 January 2023
Sites	1 location across Denmark

Drugs / interventions tested

High-intensity strength training

Conditions studied

Myositis — all drugs for Myositis →
Dermatomyositis — all drugs for Dermatomyositis →
Polymyositis — all drugs for Polymyositis →
Immune-Mediated Necrotizing Myopathy — all drugs for Immune-Mediated Necrotizing Myopathy →

Sponsor

Rigshospitalet, Denmark

Who can join

18 and older, any sex, with Myositis or Dermatomyositis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Immune-Mediated Necrotizing Myopathy (IMNM): A Story of Antibodies.
Julien S, Challier I, Malleter M, Jouen F, et al · · 2024 · cited 8× · PMID 38390873 · DOI 10.3390/antib13010012
High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol.
Jensen KY, Aagaard P, Schrøder HD, Suetta C, et al · · 2021 · cited 6× · PMID 34172544 · DOI 10.1136/bmjopen-2020-043793
High-intensity resistance training improves quality of life, muscle endurance and strength in patients with myositis: a randomised controlled trial.
Jensen KY, Aagaard P, Suetta C, Nielsen JL, et al · · 2024 · cited 2× · PMID 39192022 · DOI 10.1007/s00296-024-05698-y
High-intensity resistance training in patients with myositis - 1-year follow-up on a randomised controlled trial.
Jensen KY, Aagaard P, Suetta C, Nielsen JL, et al · · 2025 · cited 1× · PMID 40237840 · DOI 10.1007/s00296-025-05858-8

Verify or expand the search:

Other recruiting trials for Myositis

Currently open trials in the same condition.

NCT06925542 — A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease · Phase 1 · recruiting
NCT06587724 — Investigation of the Validity, Reliability, and Responsiveness of the BETY-BQ in Myositis · recruiting
NCT05895786 — A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathie · Phase 3 · recruiting
NCT05523167 — A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Infl · Phase 2, PHASE3 · active not recruiting
NCT05379634 — A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies · Phase 2 · active not recruiting

Other Rigshospitalet, Denmark trials

Trials by the same sponsor.

NCT07401368 — Clinicians' Trust in AI-Based Fetal Growth Estimates · NA · not yet recruiting
NCT07442357 — The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial · NA · not yet recruiting
NCT07528729 — Alcohol as a Modifiable Risk Factor for Atrial Fibrillation · NA · not yet recruiting
NCT07511439 — Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission · Phase 4 · not yet recruiting
NCT07467187 — Invasive Home Ventilation in Denmark · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04486261 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rigshospitalet, Denmark
Last refreshed: 10 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04486261.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing