Is There an Anti-inflammatory Effect of Aerobic Exercises on Axial Spondyloarthropathy Patients?: Prospective Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- ASDAS-CRP
Study Overview
Brief Summary
This study aimed to examine whether aerobic exercises, in addition to home exercises, have anti-inflammatory effects, which are evaluated by disease activity, acute phase reactants, and cytokine levels in axial spondyloarthropathy
Detailed Description
Spondyloarthropathies (SpAs) are a group of chronic, inflammatory, and multisystemic diseases with common genetic, epidemiological, and clinical features. These diseases primarily involve the axial skeleton.
The pathogenesis of SpA is multiple factors. The disease-specific inflammatory response, with the contribution of environmental factors based on genetic predisposition, is responsible for the pathogenesis of the disease.1 The main cytokines thought to be involved in the pathogenesis of axSpa are tumor necrosis factor-alpha (TNF-α), interleukin-17 (IL-17), IL-23, IL-22, IL-6, IL-7, interferon-gamma (IFN-γ), IL-12, and IL-26.
There is no definitive marker associated with disease activity. Studies on cytokine levels and disease activity have shown that TNF-α, IL-6, IL-17, IL-23, and IFN-γ levels may be associated with disease activity in AS patients.4-9 Nonpharmacological and pharmacological methods are used together for the treatment of SpA. Non-pharmacological methods include patient education, smoking cessation, regular exercise, and physiotherapy practices.
Aims of exercise therapy are to improve or preserve range of motion, flexibility, balance and to improve muscle strength and aerobic capacity. Posture, stretching, breathing, strengthening, and aerobic exercises are the most recommended in treating AS.
Exercise therapy is described as the cornerstone treatment of axSpA by the European Alliance of Associations for Rheumatology (EULAR). Although patient compliance with exercise therapy is not easy, the advantages of exercise are that it is cheap, low-risk, and easy to apply compared to pharmacological treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •AxSpA diagnosis according to the ASAS classification criteria
- •Voluntary participation in the study
- •Age 20-65 ages
- •Regular use of disease-modifying anti-rheumatic drugs at a stable dosage for at least 3 months
- •Regular use of NSAID at a stable dosage for at least 4 weeks
- •Presence of low disease activity (1.3 ≤ ASDAS-CRP< 2.1)
- •Having a phone number that can be used to communicate with oneself or a family member
- •At least a primary school graduate.
Exclusion Criteria
- •Presence of active peripheral joint involvement
- •Having used a biological agent at any time before
- •Exercising regularly for the previous 6 months
- •The presence of cardiovascular, orthopedic, and neurological problems that may prevent exercise (unstable angina, uncontrolled sinus tachycardia, presence of severe aortic stenosis, uncontrolled atrial or ventricular arrhythmia, 3rd degree atrioventricular block, fracture, prosthesis, neuropathy, myopathy)
- •Any other respiratory or neuromuscular disease that affects the respiratory muscles
- •Presence of malignancy
- •Presence of pregnancy
- •Having undergone any surgery in the previous 6 months,
- •Presence of severe psychiatric illness
- •Findings related to infection during interrogation
- •Having an infection in the last 3 months
- •Communication problems
- •Having known diabetes mellitus
- •The presence of severe comorbidity that may affect the kidneys and livers
- •Inability to participate in at least 75% of the exercises
- •Having left study voluntarily
- •Presence of any new symptoms or findings that develop during exercise or evaluations, and may interfere with exercise.
Outcomes
Primary Outcomes
ASDAS-CRP
Time Frame: 12 weeks
The Ankylosing Spondylitis Disease Activity Score (ASDAS) is an index to assess disease activity in Ankylosing Spondylitis (AS). The prefered score uses CRP. ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1) Back pain, patient global assessment, duration of morning stiffness and peripheral pain/swelling are all assessed on a numerical rating scale (from 0 to 10). The 3 cut-offs selected to separate these states were: \<1.3 between "inactive disease" and "moderate disease activity", \<2.1 between "moderate disease activity" and "high disease activity", and \>3.5 between "high disease activity" and "very high disease activity". Cut-offs for improvement scores were: a change ≥1.1 units for "clinically important improvement"
Tumor necrosis factor-alpha (TNF-α)
Time Frame: 12 weeks
TNF-α is a chemical messenger produced by the immune system that induces inflammation. Its relation with axial spondyloarthropathy's disease activity is uncertain but inhibition of TNF-α is one of the targets of current therapies. There were no cut-off measures for TNF-α on axial spondyloarthropathy patients.
Interleukin-17 (IL-17)
Time Frame: 12 weeks
IL-17 is a pro-inflammatory cystine knot cytokines. They are produced by a group of T helper cell known as T helper 17 cell in response to their stimulation with IL-23. Its relation with axial spondyloarthropathy's disease activity is uncertain but inhibition of IL-17 is one of the targets of current therapies. There were no cut-off measures for IL-17 on axial spondyloarthropathy patients.
C-reactive protein (CRP)
Time Frame: 12 weeks
CRP is an annular (ring-shaped) pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation. It is an acute-phase protein of hepatic origin that increases following interleukin-6 secretion by macrophages and T cells. On axial spondyloarthropathy patients it may be elevated but in some patients there could be no elevation of CRP. Also it is necessary for ASDAS-CRP calculation.
Erythrocyte Sedimentation Rate (ESR)
Time Frame: 12 weeks
Erythrocyte Sedimentation Rate (ESR) is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour. On axial spondyloarthropathy patients it may be elevated but in some patients there could be no elevation of ESR. Also it is necessary for disease activity calculation (ASDAS-ESR).
Secondary Outcomes
- Pain Visual Analogue Scale (VAS)(12 weeks)
- The Bath Ankylosing Spondylitis Functional Index (BASFI)(12 weeks)
- Bath Ankylosing Spondylitis Metrology Index (BASMI)(12 weeks)
- Chest expansion measurement(12 weeks)
- 6 minute walk test (6 MWT)(12 weeks)
- Ankylosing Spondylitis Quality of Life (ASQoL)(12 weeks)
- Weekly NSAID receive(12 weeks)
Investigators
Yeşim Ozge Gunduz Gul
Resident
Ankara Etlik City Hospital