Respiratory Training in Individuals with Ankylosing Spondylitis

NCT ID: NCT06490796

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2024-12-30

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.

Conditions

Ankylosing Spondylitis; Exercise Training; Diaphragm; Mobility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Expanded diaphragm exercise arm

participants will use Ohmbelt device during 360-degree expansive diaphragm exercise session.

Group Type: EXPERIMENTAL

Expanded diaphragm exercise

Intervention Type: BEHAVIORAL

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

Standard diaphragm exercise arm

participants will attend standard breathing exercise sessions.

Group Type: ACTIVE_COMPARATOR

Standard diaphragm exercise

Intervention Type: BEHAVIORAL

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.

Interventions

Expanded 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

Intervention Type: BEHAVIORAL

Standard 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir University of Economics

OTHER

Sponsor Role: lead

Responsible Party

Seda Yakit Yesilyurt

Assist Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Izmir University of Economics

Izmir, İzmir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.İEÜSB.0.05.05-20-279

Identifier Type: -

Identifier Source: org_study_id