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Respiratory Training in Individuals with Ankylosing Spondylitis

Which Respiratory Training is More Effective in Individuals with Ankylosing Spondylitis: 360-Degree Expandable Diaphragm Exercises or Standard Diaphragm Exercises? a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06490796
Enrollment
50
Registered
2024-07-08
Start date
2024-03-06
Completion date
2024-12-30
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Diaphragm, Exercise Training, Mobility

Keywords

Ankylosing Spondylitis, Breathing, Mobility, Functional capacity, Physiotherapy

Brief summary

This study was designed to investigate and compare the effects of standard diaphragmatic breathing and physiotherapy exercises versus 360-degree expandable diaphragmatic breathing and physiotherapy exercises on respiratory functions, respiratory muscle strength, clinical course of the disease (such as thoracic mobility, flexibility), and functional status in individuals with Ankylosing Spondylitis (AS).

Detailed description

One of the primary problems in Ankylosing Spondylitis (AS) is decreased thoracic expansion. For this reason, breathing exercises, especially thorax expansion, should be included. Moreover, according to Pascal's principle, the pressure applied to a closed fluid must be transmitted to every part of the fluid and to the walls of the space in which it is located, without decreasing (13). For this reason, it is thought that the disrupted breathing pattern cannot be adequately corrected by standard diaphragm exercises, in which the patient's hand is placed on the abdomen and the anterior abdominal wall is pushed forward/outward, and the diaphragm descent to the caudal level during inspiration with 360-degree expansion of the thoraco-abdominal cavity may not be sufficient (14). The aims of this study are as follows: 1. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises and 360-degree expanded diaphragm exercises and physiotherapy exercises on respiratory function in individuals with AS. 2. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on inspiratory and expiratory muscle strength in individuals with AS. 3. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on spinal mobility and the clinical course of the disease in individuals with AS.

Interventions

BEHAVIORALExpanded diaphragm exercise

Individuals will be instructed in 360-degree expansive diaphragm exercises using the Ohmbelt device (Nilus Medical LLC, OHMBELT, Redwood City, CA, USA). Two Ohmbelt devices will be used in this study. The placement of the devices will be as described in the literature (14,23,24): The patient will be in a seated position with hips and knees flexed at 90 degrees, both feet supported on the ground, and sitting upright on a chair without back support. In this position, the Ohmbelt devices will be secured to the patient's body. Following respiratory exercises, they will be individually enrolled in the evidence-based consensus program for three-dimensional functional exercises recommended for AS patients (26,27). The exercise protocol, which includes warm-up, mobility, stretching, flexibility, and cool-down periods, will last for 20 minutes

BEHAVIORALStandard diaphragm exercise

Individuals in this group will be instructed in standard diaphragm exercises. They will be asked to lie on their backs with their heads and knees supported by pillows, and to close their eyes to focus before starting. Following respiratory exercises, they will be individually enrolled in the evidence-based consensus program for three-dimensional functional exercises recommended for AS patients (26,27). The exercise protocol, which includes warm-up, mobility, stretching, flexibility, and cool-down periods, will last for 20 minutes.

Sponsors

Izmir University of Economics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age between 20-60 years * Diagnosis according to the 1988 Modified New York criteria * Voluntary participation * BASDAI score of 3 or 4 * No mental problems that could hinder cooperation and understanding

Exclusion criteria

* Presence of a neurological disease * Other respiratory system diseases that could affect chest expansion (COPD, asthma, etc.) * Regular exercise within the last 3 months Additionally, individuals who miss four consecutive exercise sessions or require a change in treatment will be excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Spinal movements and spinal mobilityFrom enrollment to the end of treatment at 6 weeksThe Bath Ankylosing Spondylitis Metrology Index (BASMI) will be used to measure clinical differences in spinal movements and spinal mobility. BASMI includes five measurements: cervical rotation, tragus-to-wall distance, lateral lumbar flexion, anterior lumbar flexion, and intermalleolar distance. A lower score on the BASMI indicates better spinal mobility (15).

Secondary

MeasureTime frameDescription
Respiratory muscle strengthFrom enrollment to the end of treatment at 6 weeksRespiratory muscle strength will be measured using a portable device capable of electronically measuring intraoral pressure (RP Check, MD Diagnostics Ltd., Maidstone, UK). Using the non-invasive method of intraoral pressure measurement, maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be recorded.
Expiratory Forced Vital Capacity (FVC)From enrollment to the end of treatment at 6 weeksthe maximum amount of air that can forcibly be blown out after full inspiration
Forced Expiratory Volume in one second (FEV1)From enrollment to the end of treatment at 6 weeksFEV1 is the volume of air that can forcibly be blown out in first 1 second after full inspiration.
Functional statusFrom enrollment to the end of treatment at 6 weeksThe functional status of individuals with ankylosing spondylitis will be assessed using Bath Ankylosing Spondylitis Functional Index (BASFI,0-10 cm).
FEV1/FVC ratio (FEV1%)From enrollment to the end of treatment at 6 weeksRatio of forced expiratory volume in one second to forced vital capacity.
Disease activityFrom enrollment to the end of treatment at 6 weeksDisease activity will be assessed using Ankylosing Spondylitis Disease Activity Index' in (BASDAI) clinical diagnosis and evaluation of disease activity. This index is used to define the activity, progression, and prognosis of the disease. It is interpreted on a score ranging from 0-10. An increase in the score indicates an increase in disease activity.
Forced Expiratory Flow at 25-75% of FVC (FEF25-75%)From enrollment to the end of treatment at 6 weeksMean of forced expiratory flow over the middle half of the forced vital capacity.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026