The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis
- Conditions
- Aerobic ExerciseDisease ActivityAnkylosing Spondylitis
- Interventions
- Other: Stretching exercisesDevice: Aerobic exercises with cycling ergometry
- Registration Number
- NCT05968469
- Lead Sponsor
- Afyonkarahisar Health Sciences University
- 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.
- Detailed Description
Ankylosing spondylitis (AS) is a painful and progressive chronic inflammation of the axial skeleton, mainly affecting the vertebral and sacroiliac joints. The management of AS aims to improve and maintain spinal mobility and normal posture, alleviate symptoms, reduce functional limitations and minimise complications. Due to the characteristic features of the disease, recommended spinal mobility exercises and aerobic exercises focus on reducing symptoms, improving functional capacity and quality of life, and improving and maintaining spinal mobility. Calprotectin, visfatin, leptin can be evaluated as biomarkers in inflammatory rheumatic diseases as an alternative to acute phase proteins and may reflect disease activity.
This study was designed as a prospective randomised controlled trial. Participants will be randomized into 2 groups and the intervention group will be given aerobic exercise and stretching exercise, and the other group only stretching exercise. BASDAI, BASMI, BASFI, ASQOL, ASDAS-CRP, Chest Expansion, 6 Minute Walk Test and Borg Scale will be used as assessment parameters.
Calprotectin, Visfatin, Leptin, IL-33 serum levels will be analysed by ELISA kit with blood samples taken in the early morning at the beginning of treatment, at the end of treatment (4th week) and at the 12th week after the beginning of treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Diagnosed with ankylosing spondylitis according to 2009 ASAS diagnostic criteria,
- 20-60 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise program only: Stretching exercises Patients undergoing cervical, thoracic and lumbar stretching exercises in the hospital with a physiotherapist High Intensity Interval Training (HIIT) protocol Aerobic exercises with cycling ergometry 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
- Primary Outcome Measures
Name Time Method Change in BASDAI Baseline, after 4 and 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in BASFI Baseline, after 4 and 12 weeks The Bath Ankylosing Spondylitis Functional Index (BASFI) is a sensitive and reliable index developed for the determination and follow-up of functional status in patients with AS. It consists of 10 questions evaluating the functions of the patients. The final score is obtained by dividing the total score by 10 using the VAS in the range of 0-10 cm for each question. A high score indicates poor function.
Change in Chest Expansion Baseline, after 4 and 12 weeks Chest expansion is determined by measuring the chest circumference following a deep inspiration and forced expiration. The expansion of the chest circumference is recorded in centimetres.
Change in ASDAS-CRP Baseline, after 4 and 12 weeks The Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS-CRP) consists of four questions and the acute phase reactants CRP mg/L result. ASDAS-CRP will be calculated together with the CRP result in the formula. Mild disease activity \<1.3 Moderate disease activity 1.3-2.1 High disease activity 2.1-3.5 Very high disease activity \>3.5
Change in 6 Minute Walk Test Baseline, after 4 and 12 weeks The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The score of the test is the distance a patient walks in 6 minutes.
Change in BASMI Baseline, after 4 and 12 weeks The Bath Ankylosing Spondylitis Metrology Index (BASMI) is related to the spinal mobility of patients with ankylosing spondylitis. It consists of 5 clinical measurements. The total score of 5 measurements is obtained, the score range is between 0-10, a lower score means better spinal mobility.
Change in Borg Scale Baseline, after 4 and 12 weeks The Borg scale is a numerical expression of the verbal expression of exercise intensity in patients undergoing cycle ergometry. It allows direct comparison of individuals. 6 to 20 are evaluated. The Borg scale is a numerical expression of the verbal expression of exercise intensity in patients undergoing cycling ergometry. It allows direct comparison of individuals. 6 to 20 are evaluated. As the activity becomes more difficult for the patient, the values given increase.
Change in ASQOL Baseline, after 4 and 12 weeks The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) is the most widely used questionnaire to assess quality of life in AS, and it is valid and reliable. In this questionnaire consisting of eighteen questions, patients are asked to answer yes or no to each question. The total score varies between 0-18. High scores indicate serious deterioration in quality of life
Trial Locations
- Locations (1)
Afyonkarahisar Health Sciences University
🇹🇷Afyonkarahisar, Turkey