High-intensity Interval Exercise in Rheumatoid Arthritis (RA-HIIT)

Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: High intensity exercise

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital
  • Uddevalla, Sweden
    • Uddevalla Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Cardiorespiratory and strength exercise training 2-3 sessions per week	Behavioral: 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.; Other Names: Person- centeredness
No Intervention: Care as usual; Care as usual and information of health enhancing physical activity according to general recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary function	Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)	0 -12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of disease activity	Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)	0-12 weeks
Level of disease activity	Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)	0-6 months
Level of disease activity	Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)	0-12 months
Homeostatic model assessment of insulin resistance (HOMA IR)	Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report HOMA IR	0-12 weeks
Glycosylation level of hemoglobin (HbA1c)	Glycosylation level of hemoglobin (mmol/mol)	0-12 weeks
Level of blood lipids	Levels of triglycerides (mmol/L), Level of high-density lipoprotein (HDL) (mmol/L), low-density lipoprotein (LDL) ( mmol/L), Total cholesterol (mmol/L )	0-12 weeks
Erythrocyte Sedimentation Rate (ESR)	Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)	0-12 weeks
Erythrocyte Sedimentation Rate (ESR)	Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)	0-6 months
Erythrocyte Sedimentation Rate (ESR)	Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)	0-12 months
C-Reactive Protein (CRP)	Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)	0-12 weeks
C-Reactive Protein (CRP)	Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)	0-6 months
C-Reactive Protein (CRP)	Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)	0-12 months
Cytokine levels	Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL)	0-12 weeks
Muscle function of lower extremities	The one minute sit-to-stand test (Higher numbers of complete rises indicate better muscle function in lower extremities)	0-12 weeks
Hand-grip force	Hand-grip force is assessed with a dynamometer ( Higher value indicate better grip strength)	0-12 weeks
Self-reported physical activity	Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)	0-12 weeks
Self-reported physical activity	Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)	0-6 months
Self-reported physical activity	Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)	0-12 months
Objective assessment of physical activity	Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)	0-12 weeks
Objective assessment of physical activity	Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)	0-6 months
Objective assessment of physical activity	Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)	0-12 months
Pain intensity	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)	0-12 weeks
Pain intensity	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)	0-6 months
Pain intensity	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)	0-12 months
Global health	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)	0-12 weeks
Global health	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)	0-6 months
Global health	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)	0-12 months
Fatigue	The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue	0-12 weeks
Fatigue	The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue	0-6 months
Fatigue	The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue	0-12 months
Activity limitations	Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)	0-12 weeks
Activity limitations	Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)	0-6 months
Activity limitations	Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)	0-12 months
Attitude to exercise	Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.	0-12 weeks
Attitude to exercise	Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.	0-6 moths
Attitude to exercise	Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.	0-12 months
Body compositions	Weight and height will be combined to report Body mass index BMI kg/m2 (A higher score indicate higher relative weight)	0-12 weeks
Waist circumference	Measured with a tape measure midway between the lower rib and iliac crest. (A waist measurement of 80 centimeters or more for women and 94 centimeters or more for men indicate increased risk for diseases related to overweight)	0-12 weeks
Vascular function	Aortic pulse wave velocity (PWV) (m/sec.) (Higher PWV value indicate worse vascular function)	0-12 weeks
Sleep	Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).	0-12 weeks
Sleep	Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).	0-6 months
Sleep	Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).	0-12 months

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Göteborg University
• Investigators: Study Director: Annelie Bilberg, PhD, Vastra Gotaland Region

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Conditioning, Human; Exercise; High-Intensity Interval Training
• Other Study ID Numbers: Vastra Gotaland record 275642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in a publication are available from the principal investigator (P.I.) on reasonable request. Access will be determined based on reasonable request and in accordance with the ethical approval
• IPD Sharing Time Frame: The data will become available as following, starting 6 months after publication and end 5 years after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No