The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis

NCT05968469 | Completed

• 1 other identifier: ASHIIT2023
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to investigate the effects of aerobic exercise and stretching exercises applied in high-intensity interval training protocol on disease activity, quality of life, spinal mobility and calprotectin, visfatin, leptin, IL-33 serum levels in patients with Ankylosing Spondylitis.

Conditions

Ankylosing Spondylitis; Aerobic Exercise; Disease Activity

Keywords

Ankylosing Spondylitis; Spinal Mobility; Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

• Change in BASDAI

  The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consists of 6 questions about disease activity. Each question is scored on a scale of 0 to 10. High scores means high disease activity. It is a reliable and sensitive to changes index developed to assess disease activity and progression.

  Baseline, after 4 and 12 weeks

Secondary Outcomes (7)

• Change in BASMI

  Baseline, after 4 and 12 weeks

• Change in BASFI

  Baseline, after 4 and 12 weeks

• Change in ASQOL

  Baseline, after 4 and 12 weeks

• Change in ASDAS-CRP

  Baseline, after 4 and 12 weeks

• Change in Chest Expansion

  Baseline, after 4 and 12 weeks

Study Arms (2)

High Intensity Interval Training (HIIT) protocol

EXPERIMENTAL

Patients who underwent cycling ergometry program including high-intensity interval (HIIT) in the cardiopulmonary rehabilitation unit and stretching exercises for the cervical, thoracic and lumbar regions under the guidance of a physiotherapist

Device: Aerobic exercises with cycling ergometry

Exercise program only:

ACTIVE COMPARATOR

Patients undergoing cervical, thoracic and lumbar stretching exercises in the hospital with a physiotherapist

Other: Stretching exercises

Interventions

Aerobic exercises with cycling ergometry DEVICE

A total of 20 sessions of high-intensity interval (HIIT) aerobic exercise program will be applied to the patients using a bicycle ergometer, five days a week and once a day for four weeks. And then, it was planned to perform stretching exercises for the cervical, thoracic and lumbar regions and posture exercises accompanied by a specialist physiotherapist. The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.

High Intensity Interval Training (HIIT) protocol

Stretching exercises OTHER

Stretching exercises for the cervical, thoracic and lumbar regions and posture exercises were planned to be performed with the expert physiotherapist. The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.

Exercise program only:

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with ankylosing spondylitis according to 2009 ASAS diagnostic criteria,
• years old, male and female gender,
• No change in anti-rheumatic drugs and dosage in the last 3 months
• Those who have not done regular physical activity in the last 3 months,
• Patients who do not have any orthopedic, neurological or mental illness that may affect exercise will be included in the study.

You may not qualify if:

• Active malignancy and/or history of malignancy in the last 5 years,
• Uncontrolled cardiopulmonary disease,
• Unstable angina pectoris, cardiac arrhythmias and myocardial infarction within the last 3 months
• Presence of pregnancy or those planning a pregnancy in the near future,
• History of major surgery (including joint surgery) within the last six months
• Use of assistive devices for ambulation or orthopaedic joint prosthesis
• Patients with total spinal ankyloses
• Patients with a history of syncope, exercise-induced arrhythmia
• Regular exercise in the last 3 months
• Patients with contracture of the knee joint that prevents cycling exercise

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related Publications (3)

• Yurdakul OV, Rezvani A. Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis? Medicine (Baltimore). 2018 Sep;97(39):e12609. doi: 10.1097/MD.0000000000012609.

  PMID: 30278577 BACKGROUND

• Jennings F, Oliveira HA, de Souza MC, Cruz Vda G, Natour J. Effects of Aerobic Training in Patients with Ankylosing Spondylitis. J Rheumatol. 2015 Dec;42(12):2347-53. doi: 10.3899/jrheum.150518. Epub 2015 Nov 1.

  PMID: 26523029 RESULT

• Diaconu AD, Ceasovschih A, Sorodoc V, Pomirleanu C, Lionte C, Sorodoc L, Ancuta C. Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis. Int J Mol Sci. 2022 Sep 30;23(19):11561. doi: 10.3390/ijms231911561.

  PMID: 36232862 RESULT

Related Links

• Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis?
• Effects of Aerobic Training in Patients with Ankylosing Spondylitis
• Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nuran EYVAZ, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 1, 2023
• Study Start: July 30, 2023
• Primary Completion: October 21, 2024
• Study Completion: January 12, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)