- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06138717
The Effect of Aerobic Exercises and Yoga Exercises in Axial Spondyloarthritis
The Effect of Aerobic Exercises and Yoga Exercises on Spinal Mobility, Functional Capacity and Disease Activity in Axial Spondyloarthritis: a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
The study included 60 AxSpA patients according to ASAS criteria. Patients will be divided into two groups randomised. Group 1 (n=30) received only aerobic exercise, group 2 (n=30) received aerobic exercise and yoga exercises will be applied. Aerobic exercise intensity will be measured by cardiopulmonary exercise test (CPET). determined.
Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions. In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed. A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 sessions.
Functional capacity before and after treatment, 6-min walk test (6MWT) and VO2 maximum and disease activity will be assessed by ASDAS-CRP. Clinical measurements Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life (ASQL) scale will be used. Fibromyalgia symptom severity scale and widespread pain index scores will be calculated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Recruiting
- Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
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Contact:
- Nilüfer Kutay GÖKKAYA Prof MD
- Phone Number: +90312 5526000
- Email: ankarasehir@saglik.gov.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Axial spondyloarthritis patients according to ASAS criteria having a stable health condition, having ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, or depression complaints
Exclusion Criteria:
- Hemodynamically unstable, cardiac and pulmonary system unstable, with neurological, and psychological disorders patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: only aerobic exercise
Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.
|
Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed.
A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session
Other Names:
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|
Active Comparator: combine aerobic exercise and yoga exercises
Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session
|
Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed.
A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO2 max
Time Frame: six week
|
VO2 max is the maximum rate of oxygen consumption attainable during physical exertion
|
six week
|
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Six minute walk test
Time Frame: six week
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The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
|
six week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BASMI
Time Frame: six week
|
The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an index comprising 5 measures of spinal and hip mobility in AS
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six week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Refiye000000000000000000000002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Axial Spondyloarthritis and Ankylosing Spondylitis
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University of BonnNovartis; Novartis PharmaceuticalsRecruitingAxial Spondyloarthritis | Axial and Peripheral Spondyloarthritis | Axial Spondyloarthopathy | Axial Spondyloarthritis and Ankylosing Spondylitis | Axial Spondyloarthritis (AxSpA) | Axial Spondylarthritis (r-axSpA) | Axial Spondyloarthritis, Non-RadiographicGermany
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Sinem Kübra BekeNot yet recruitingAxial Spondyloarthritis (Ankylosing Spondylitis)Turkey (Türkiye)
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Saglik Bilimleri UniversitesiRecruitingAnkylosing SpondylitisTurkey (Türkiye)
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SPH-BIOCAD (HK) LimitedCompleted
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