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The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis, Aerobic Exercise, Disease Activity

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic exercises with cycling ergometry
Stretching exercises
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, Spinal Mobility, Aerobic Exercise

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Afyonkarahisar Health Sciences UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Interval Training (HIIT) protocol

Exercise program only:

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in BASMI
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 BASFI
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 ASQOL
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
Change in ASDAS-CRP
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 Chest Expansion
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 6 Minute Walk Test
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 Borg Scale
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.

Full Information

First Posted
July 14, 2023
Last Updated
September 16, 2023
Sponsor
Afyonkarahisar Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05968469
Brief Title
The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis
Official Title
The Effect of Aerobic Exercise Program on Disease Activity, Quality of Life, Spinal Mobility and Serum Calprotectin, Visfatin, Leptin,IL-33 Levels in Patients With Ankylosing Spondylitis: Ultrasonographic Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis, Aerobic Exercise, Disease Activity
Keywords
Ankylosing Spondylitis, Spinal Mobility, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training (HIIT) protocol
Arm Type
Experimental
Arm Description
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
Arm Title
Exercise program only:
Arm Type
Active Comparator
Arm Description
Patients undergoing cervical, thoracic and lumbar stretching exercises in the hospital with a physiotherapist
Intervention Type
Device
Intervention Name(s)
Aerobic exercises with cycling ergometry
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BASDAI
Description
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.
Time Frame
Baseline, after 4 and 12 weeks
Secondary Outcome Measure Information:
Title
Change in BASMI
Description
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.
Time Frame
Baseline, after 4 and 12 weeks
Title
Change in BASFI
Description
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.
Time Frame
Baseline, after 4 and 12 weeks
Title
Change in ASQOL
Description
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
Time Frame
Baseline, after 4 and 12 weeks
Title
Change in ASDAS-CRP
Description
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
Time Frame
Baseline, after 4 and 12 weeks
Title
Change in Chest Expansion
Description
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.
Time Frame
Baseline, after 4 and 12 weeks
Title
Change in 6 Minute Walk Test
Description
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.
Time Frame
Baseline, after 4 and 12 weeks
Title
Change in Borg Scale
Description
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.
Time Frame
Baseline, after 4 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Afyonkarahisar Health Sciences University
City
Afyonkarahisar
ZIP/Postal Code
03200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faruk Emre YULCU
Phone
+905301840495
Email
farukemreyulcu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30278577
Citation
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.
Results Reference
background
PubMed Identifier
26523029
Citation
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.
Results Reference
result
PubMed Identifier
36232862
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30278577/
Description
Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis?
URL
https://pubmed.ncbi.nlm.nih.gov/26523029/
Description
Effects of Aerobic Training in Patients with Ankylosing Spondylitis
URL
https://pubmed.ncbi.nlm.nih.gov/36232862/
Description
Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis

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The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis

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