Effect of Aerobic Exercises on Axial Spondyloarthropathy

NCT ID: NCT06699238

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-07-21

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.

Conditions

Axial Spondyloarthritis (AxSpA); Aerobic Exercise; Disease Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home Exercise Group

The home exercise group performed only standard conventional exercises for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.

Group Type: ACTIVE_COMPARATOR

Home Exercise

Intervention Type: OTHER

Standard conventional exercise for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.

Aerobic Exercise Group

The aerobic exercise group performed the following training: warm-up for 5 min, walking for 20 min at an intensity that would use 60-70% of the HR reserve, and cool down for 5 min. Additionally, they performed standard conventional exercises at home for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. The aerobic exercise group performed on a treadmill under the supervision of a physician.

Group Type: EXPERIMENTAL

Home Exercise

Intervention Type: OTHER

Standard conventional exercise for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.

Aerobic exercise

Intervention Type: OTHER

The aerobic exercise group performed the following training: warm-up for 5 min, walking for 20 min at an intensity that would use 60-70% of the HR reserve, and cool down for 5 min. Additionally, they performed standard conventional exercises at home for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.The aerobic exercise group performed on a treadmill under the supervision of a physician.

Interventions

Home Exercise

Standard conventional exercise for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.

Intervention Type: OTHER

Aerobic exercise

The aerobic exercise group performed the following training: warm-up for 5 min, walking for 20 min at an intensity that would use 60-70% of the HR reserve, and cool down for 5 min. Additionally, they performed standard conventional exercises at home for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.The aerobic exercise group performed on a treadmill under the supervision of a physician.

Intervention Type: OTHER

Other Intervention Names

Conventional Exercise

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role: collaborator

Yeşim Ozge Gunduz Gul

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yeşim Ozge Gunduz Gul

Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ajda Bal, MD, Professor

Role: STUDY_DIRECTOR

Ankara Etlik City Hospital

Locations

Ankara Etlik City Hospital Physical Medicine and Rehabilitation Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AnkaraEtlik-FTR-YOGG-01

Identifier Type: -

Identifier Source: org_study_id