Clinical trial NCT06699238: Effect of Aerobic Exercises on Axial Spondyloarthropathy
Official title: Is There an Anti-inflammatory Effect of Aerobic Exercises on Axial Spondyloarthropathy Patients?: Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axial Spondyloarthritis (AxSpA)
Aerobic Exercise
Disease Activity
Keywords: axial spondyloarthritis
aerobic exercises
cytokines
acute phase biomarkers
non pharmacological intervention
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Ankara Diskapi Training and Research Hospital
First posted: 2024-11-21
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, one group was provided home exercise program and one group run on the treadmill in addition to their home exercise program
Primary purpose: TREATMENT

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.

The anti-inflammatory effects of exercise have recently been discussed. Few studies have investigated the anti-inflammatory effects of exercise in patients with AS. While some of these studies showed significant improvement in disease activity, functional status, flexibility, and CRP with aerobic exercise in patients with AS, some did not. Although a few studies have shown a significant decrease in TNF-α levels in AS patients with non-aerobic exercise programs, no study has examined the changes in TNF-α and IL-17 levels with aerobic exercise treatment.

The primary aim of our study was to examine whether aerobic exercise, in addition to the home exercise program, has an anti-inflammatory effect in patients with axSpA, as evaluated by disease activity, acute phase reactants, and cytokine levels. Our secondary aim was to determine whether aerobic exercise, in addition to home exercise, has a positive effect on functional status, functional exercise capacity, quality of life, NSAID consumption, chest expansion, and spinal mobility.

Eligibility criteria: 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.

Primary outcomes:
measure: ASDAS-CRP
timeFrame: 12 weeks
measure: Tumor necrosis factor-alpha (TNF-α)
timeFrame: 12 weeks
measure: Interleukin-17 (IL-17)
timeFrame: 12 weeks
measure: C-reactive protein (CRP)
timeFrame: 12 weeks
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain Visual Analogue Scale (VAS)
timeFrame: 12 weeks
measure: The Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 12 weeks
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: 12 weeks
measure: Chest expansion measurement
timeFrame: 12 weeks
measure: 6 minute walk test (6 MWT)
timeFrame: 12 weeks
measure: Ankylosing Spondylitis Quality of Life (ASQoL)
timeFrame: 12 weeks
measure: Weekly NSAID receive
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital Physical Medicine and Rehabilitation Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: Ajda Bal, MD, Professor
role: STUDY_DIRECTOR
References: