Clinical trial NCT05768165: High-intensity Interval Exercise in Rheumatoid Arthritis
Official title: Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2023-03-14
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention versus care as usual
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cardiopulmonary function
timeFrame: 0 -12 weeks
Secondary outcomes:
measure: Vascular function
timeFrame: 0-12 weeks
measure: Level of disease activity
timeFrame: 0-12 weeks
measure: Level of disease activity
timeFrame: 0-6 months
measure: Level of disease activity
timeFrame: 0-12 months
measure: Homeostatic model assessment of insulin resistance (HOMA IR)
timeFrame: 0-12 weeks
measure: Glycosylation level of hemoglobin (HbA1c)
timeFrame: 0-12 weeks
measure: Level of blood lipids
timeFrame: 0-12 weeks
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: 0-12 weeks
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: 0-6 months
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: 0-12 months
measure: C-Reactive Protein (CRP)
timeFrame: 0-12 weeks
measure: C-Reactive Protein (CRP)
timeFrame: 0-6 months
measure: C-Reactive Protein (CRP)
timeFrame: 0-12 months
measure: Cytokine levels
timeFrame: 0-12 weeks
measure: Muscle function of lower extremities
timeFrame: 0-12 weeks
measure: Hand-grip force
timeFrame: 0-12 weeks
measure: Self-reported physical activity
timeFrame: 0-12 weeks
measure: Self-reported physical activity
timeFrame: 0-6 months
measure: Self-reported physical activity
timeFrame: 0-12 months
measure: Objective assessment of physical activity
timeFrame: 0-12 weeks
measure: Objective assessment of physical activity
timeFrame: 0-6 months
measure: Objective assessment of physical activity
timeFrame: 0-12 months
measure: Pain intensity
timeFrame: 0-12 weeks
measure: Pain intensity
timeFrame: 0-6 months
measure: Pain intensity
timeFrame: 0-12 months
measure: Global health
timeFrame: 0-12 weeks
measure: Global health
timeFrame: 0-6 months
measure: Global health
timeFrame: 0-12 months
measure: Fatigue
timeFrame: 0-12 weeks
measure: Fatigue
timeFrame: 0-6 months
measure: Fatigue
timeFrame: 0-12 months
measure: Sleep
timeFrame: 0-12 weeks
measure: Sleep
timeFrame: 0-6 months
measure: Sleep
timeFrame: 0-12 months
measure: Activity limitations
timeFrame: 0-12 weeks
measure: Activity limitations
timeFrame: 0-6 months
measure: Activity limitations
timeFrame: 0-12 months
measure: Attitude to exercise
timeFrame: 0-12 weeks
measure: Attitude to exercise
timeFrame: 0-6 moths
measure: Attitude to exercise
timeFrame: 0-12 months
measure: Body compositions
timeFrame: 0-12 weeks
measure: Waist circumference
timeFrame: 0-12 weeks
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska university hospital
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
Study officials:
affiliation: Vastra Gotaland Region
name: Annelie Bilberg, PhD
role: STUDY_DIRECTOR
References: