High-intensity Interval Exercise in Rheumatoid Arthritis

NCT05768165 | Active Not Recruiting DMC

• 1 other identifier: Vastra Gotaland record 275642
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary function

  Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)

  0 -12 weeks

Secondary Outcomes (42)

• Vascular function

  0-12 weeks

• Level of disease activity

  0-12 weeks

• Level of disease activity

  0-6 months

• Level of disease activity

  0-12 months

• Homeostatic model assessment of insulin resistance (HOMA IR)

  0-12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Cardiorespiratory and strength exercise training 2-3 sessions per week

Behavioral: High intensity exercise

Care as usual

NO INTERVENTION

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

Interventions

High intensity exercise 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.

Also known as: Person- centeredness

Intervention group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (2)

Sahlgrenska university hospital

Gothenburg, 413 45, Sweden

Location

Uddevalla Hospital

Uddevalla, Sweden

Location

Related Publications (2)

• 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.

  PMID: 40968365 DERIVED

• 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.

  PMID: 39179363 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Annelie Bilberg, PhD

  Vastra Gotaland Region

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Intervention versus care as usual

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: March 14, 2023
• Study Start: August 16, 2021
• Primary Completion: June 30, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will become available as following, starting 6 months after publication and end 5 years after publication.
• Access Criteria: The requests will be reviewed by the P.I. and the steering committee. Study plans on meta-analyses generating new knowledge on exercise in persons with rheumatic diseases will be approved.

Locations

SE (2)