Effect of Aerobic Exercises on Axial Spondyloarthropathy

NCT06699238 | Completed

• 1 other identifier: AnkaraEtlik-FTR-YOGG-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Axial Spondyloarthritis (AxSpA); Aerobic Exercise; Disease Activity

Keywords

axial spondyloarthritis; aerobic exercises; cytokines; acute phase biomarkers; non pharmacological intervention

Outcome Measures

Primary Outcomes (5)

• ASDAS-CRP

  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"

  12 weeks

• Tumor necrosis factor-alpha (TNF-α)

  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.

  12 weeks

• Interleukin-17 (IL-17)

  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.

  12 weeks

• C-reactive protein (CRP)

  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.

  12 weeks

• Erythrocyte Sedimentation Rate (ESR)

  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).

  12 weeks

Secondary Outcomes (7)

• 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

Study Arms (2)

Home Exercise Group

ACTIVE COMPARATOR

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.

Other: Home Exercise

Aerobic Exercise Group

EXPERIMENTAL

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.

Other: Home Exercise; Other: Aerobic exercise

Interventions

Home Exercise 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.

Also known as: Conventional Exercise

Aerobic Exercise Group; Home Exercise Group

Aerobic exercise 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.

Aerobic Exercise Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeşim Ozge Gunduz Gul: lead
• Ankara Diskapi Training and Research Hospital: collaborator

Study Sites (1)

Ankara Etlik City Hospital Physical Medicine and Rehabilitation Hospital

Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ajda Bal, MD, Professor

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident

Model Details: Two groups, one group was provided home exercise program and one group run on the treadmill in addition to their home exercise program

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: November 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: July 21, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)