Respiratory Training in Individuals with Ankylosing Spondylitis

Not Applicable

Completed

• Conditions: Ankylosing Spondylitis; Exercise Training; Mobility; Diaphragm
• Interventions: Behavioral: Expanded diaphragm exercise; Behavioral: Standard diaphragm exercise

• Registration Number: NCT06490796
• Lead Sponsor: Izmir University of Economics

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.

Study Timeline

• Study Start: 2024-03-06
• Study First Submitted: 2024-06-07
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-08
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-30
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expanded diaphragm exercise arm	Expanded diaphragm exercise	participants will use Ohmbelt device during 360-degree expansive diaphragm exercise session.
Standard diaphragm exercise arm	Standard diaphragm exercise	participants will attend standard breathing exercise sessions.

Primary Outcome Measures

Name	Time	Method
Spinal movements and spinal mobility	From enrollment to the end of treatment at 6 weeks	The 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 Outcome Measures

Name	Time	Method
Disease activity	From enrollment to the end of treatment at 6 weeks	Disease 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 weeks	Mean of forced expiratory flow over the middle half of the forced vital capacity.
Functional status	From enrollment to the end of treatment at 6 weeks	The functional status of individuals with ankylosing spondylitis will be assessed using Bath Ankylosing Spondylitis Functional Index (BASFI,0-10 cm).
Respiratory muscle strength	From enrollment to the end of treatment at 6 weeks	Respiratory 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 weeks	the 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 weeks	FEV1 is the volume of air that can forcibly be blown out in first 1 second after full inspiration.
FEV1/FVC ratio (FEV1%)	From enrollment to the end of treatment at 6 weeks	Ratio of forced expiratory volume in one second to forced vital capacity.

Trial Locations

Locations (1)

Izmir University of Economics; 🇹🇷 Izmir, Turkey