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Clinical Trials/NCT05768165
NCT05768165
Active, Not Recruiting
N/A

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

Vastra Gotaland Region2 sites in 1 country87 target enrollmentAugust 16, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Vastra Gotaland Region
Enrollment
87
Locations
2
Primary Endpoint
Cardiopulmonary function
Status
Active, Not Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 16, 2021
End Date
December 30, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vastra Gotaland Region
Responsible Party
Sponsor

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
  • 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.

Outcomes

Primary Outcomes

Cardiopulmonary function

Time Frame: 0 -12 weeks

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

Secondary Outcomes

  • Vascular function(0-12 weeks)
  • Level of disease activity(0-12 months)
  • Homeostatic model assessment of insulin resistance (HOMA IR)(0-12 weeks)
  • Glycosylation level of hemoglobin (HbA1c)(0-12 weeks)
  • Level of blood lipids(0-12 weeks)
  • Erythrocyte Sedimentation Rate (ESR)(0-12 months)
  • C-Reactive Protein (CRP)(0-12 months)
  • Cytokine levels(0-12 weeks)
  • Muscle function of lower extremities(0-12 weeks)
  • Hand-grip force(0-12 weeks)
  • Self-reported physical activity(0-12 months)
  • Objective assessment of physical activity(0-12 months)
  • Pain intensity(0-12 months)
  • Waist circumference(0-12 weeks)
  • Global health(0-12 months)
  • Fatigue(0-12 months)
  • Sleep(0-12 months)
  • Attitude to exercise(0-12 months)
  • Body compositions(0-12 weeks)
  • Activity limitations(0-12 months)

Study Sites (2)

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