- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07262294
Deep Breathing Combined With Core Stability Exercises in the Treatment of Patients With Ankylosing Spondylitis (RCT)
The Effect of Deep Breathing Added to Core Stability Exercises in the Treatment of Patients With Ankylosing Spondylitis: A Randomized Controlled Trial
Exercise may be considered the gold standard for the management of mechanical and functional symptoms associated with patients having AS and they are considered as a safe and effective treatment for improving strength, spinal mobility, and physical fitness in general. However, there were no definite types or doses recommended over others.
Additionally, poor posture is one of the consequences of AS due to pain, loss of flexibility, and muscular weakness which may also affect respiratory function. This faulty mechanical posture of the thoracic and cervical spine may affect the pulmonary function of these patients. Therefore, the purpose of the current study is to investigate the efficacy of deep breathing exercises added to core stability exercises in the treatment of patients suffering from AS.
Study Overview
Detailed Description
The management of AS typically involves a multidisciplinary approach which includes both medical and physical therapy approaches, concerning the medical treatment, NSAIDs are widely used for pain relief and inflammation control in AS patients and were recommended for the management of patients having AS. The efficacy of NSAIDs has been well-documented in research studies, Disease-modifying antirheumatic Drugs (DMARDs), including sulfasalazine and methotrexate, play a crucial role in suppressing inflammation and preventing joint damage in AS patients, or biologics, such as tumor necrosis factor (TNF) inhibitors (adalimumab, etanercept, infliximab), have transformed AS treatment by specifically targeting inflammatory pathways and significantly improving symptoms and function.
Respecting the physical therapy approach plays a crucial role aims to maintaining and improving mobility, reducing pain, enhancing overall function, correcting mal-positioning, and improving patients' psychological status in patients with ankylosing spondylitis. It usually includes a combination of exercises such as Range of Motion (ROM) exercises, strengthening exercises, Cardiovascular exercises, postural training, patient education, assistive devices, Adaptations, and monitoring. Different types of exercises have been studied for managing patients having AS, however, no specific type has been recommended over others. Additionally, up to our knowledge, there were no studies has addressed the respiratory function that may be affected with patients having AS either from postural abnormalities, lack of spinal flexibility, or generalized functional limitations. Therefore, the current study aims to evaluate if deep breathing exercises as a complementary intervention would be of some value when added to core stability exercises for patients suffering from AS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Banī Suwayf, Egypt
- Recruiting
- Beni Suef university hospital
-
Contact:
- Mariam Mohamed Abd Allah, Lecturer
- Phone Number: + 2001010222497
- Email: drmariamortho@pt.bsu.edu.eg
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Principal Investigator:
- Mariam Abd Allah, Lecturer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Receiving the same medical treatment
- Age range between 20 and 45 years
- Includes both male and female patients
- Diagnosed with stable ankylosing spondylitis (AS) for at least 3 months
- Not engaged in any other rehabilitation programs within the last 6 months
Exclusion Criteria:
- Presence of other systemic or neurological disorders
- Any change in medication within the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Deep Breathing exercise plus Core stability exercises
Deep Breathing exercise is a type of exercise that engage the diaphragm to enhance the respiratory function, improve lung efficiency, and induce relaxation which improve the overall health condition.
|
Exercises
|
|
Active Comparator: Core Stability Exercises
Core Stability exercises are group of exercises designed to strengthen abdominal, back, lower limbs, and pelvis muscles which enhance posture and provide stability and body control during daily activities
|
Exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory function
Time Frame: Patients will be examined after 4 to 6 weeks
|
Forced vital capacity (FVC) which measure lung volume, and it reflects the capacity of the lung. Forced expiratory volume in 1 second (FEV1) which measure lung velocity, and it evaluate the presence of airway obstruction. FEV1/FVC it the index that differentiate between obstructive and restrictive lung disease. |
Patients will be examined after 4 to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional exercise capacity
Time Frame: Patients will be examined after 4 to 6 weeks
|
The physical functional performance will be assessed by a six-minute walk test (6 MWT)
|
Patients will be examined after 4 to 6 weeks
|
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Axial Spondyloarthritis
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Spinal Diseases
- Spondylarthropathies
- Ankylosis
- Spondylarthritis
- Spondylitis
- Spondylitis, Ankylosing
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- Physical Therapy, Beni-Suef.
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.
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