High-intensity Interval Exercise in Rheumatoid Arthritis

NCT ID: NCT05768165

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention versus care as usual
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Single blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Cardiorespiratory and strength exercise training 2-3 sessions per week

Group Type EXPERIMENTAL

High intensity exercise

Intervention Type BEHAVIORAL

Twelve weeks of supervised high intensity aerobic and resistance exercise including two sessions/week, one additional session of the patient´s own choice, non-supervised. The target of the high intensity intervals (HIIT) is 90%-95% of maximum heart rate alternated with recovery phases at 70% of maximal heart rate. The resistance exercise session of large muscle groups: 8-10 repetitions, 2-3 sets.

Exercise guidance follows principles of self-efficacy and person-centeredness.

Care as usual

Care as usual and information of health enhancing physical activity according to general recommendations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High intensity exercise

Twelve weeks of supervised high intensity aerobic and resistance exercise including two sessions/week, one additional session of the patient´s own choice, non-supervised. The target of the high intensity intervals (HIIT) is 90%-95% of maximum heart rate alternated with recovery phases at 70% of maximal heart rate. The resistance exercise session of large muscle groups: 8-10 repetitions, 2-3 sets.

Exercise guidance follows principles of self-efficacy and person-centeredness.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Person- centeredness

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria
* Disease duration \>1 year
* Age (range 20-60 years)
* Stable medication on anti- rheumatic drugs for \>3 months
* Low-to-moderate disease activity (\<5.1) according to the Disease activity score 28 (DAS28)

Exclusion Criteria

* Cerebrovascular diseases
* Diabetes
* Severe hypertension
* Chronic obstructive pulmonary disease or other severe pulmonary diseases
* Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise
* Arthroplasty of large joints
* Inability to manage Cardiopulmonary Exercise Testing (CPET)
* Pregnancy
* Already participating in regular aerobic or strength exercise at a high intensity level (\>1 hours/ week) during the last 6 months
* Inability to speak or read Swedish.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Göteborg University

OTHER

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Annelie Bilberg, PhD

Role: STUDY_DIRECTOR

Vastra Gotaland Region

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sahlgrenska university hospital

Gothenburg, , Sweden

Site Status

Uddevalla Hospital

Uddevalla, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Bilberg A, Mannerkorpi K, Borjesson M, Svedlund S, Sivertsson J, Klingberg E, Bjersing J. High-intensity interval training improves cardiovascular and physical health in patients with rheumatoid arthritis: a multicentre randomised controlled trial. Br J Sports Med. 2024 Dec 2;58(23):1409-1418. doi: 10.1136/bjsports-2024-108369.

Reference Type DERIVED
PMID: 39179363 (View on PubMed)

Bilberg A, Bjersing J, Borjesson M, Sivertsson J, Mannerkorpi K. High-intensity exercise improves multidimensional fatigue and health-related quality of life in rheumatoid arthritis: a randomized controlled study. Arthritis Res Ther. 2025 Sep 18;27(1):176. doi: 10.1186/s13075-025-03643-3.

Reference Type DERIVED
PMID: 40968365 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Vastra Gotaland record 275642

Identifier Type: -

Identifier Source: org_study_id