Respiratory Training in Individuals with Ankylosing Spondylitis

NCT06490796 | Completed

• 1 other identifier: B.30.2.İEÜSB.0.05.05-20-279
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Ankylosing Spondylitis; Exercise Training; Diaphragm; Mobility

Keywords

Ankylosing Spondylitis; Breathing; Mobility; Functional capacity; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Spinal movements and spinal mobility

  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).

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (7)

• Functional status

  From enrollment to the end of treatment at 6 weeks

• Respiratory muscle strength

  From enrollment to the end of treatment at 6 weeks

• Expiratory Forced Vital Capacity (FVC)

  From enrollment to the end of treatment at 6 weeks

• Forced Expiratory Volume in one second (FEV1)

  From enrollment to the end of treatment at 6 weeks

• Forced Expiratory Flow at 25-75% of FVC (FEF25-75%)

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Expanded diaphragm exercise arm

EXPERIMENTAL

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

Behavioral: Expanded diaphragm exercise

Standard diaphragm exercise arm

ACTIVE COMPARATOR

participants will attend standard breathing exercise sessions.

Behavioral: Standard diaphragm exercise

Interventions

Expanded diaphragm exercise 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

Expanded diaphragm exercise arm

Standard diaphragm exercise 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.

Standard diaphragm exercise arm

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir University of Economics: lead

Study Sites (1)

Izmir University of Economics

Izmir, İzmir, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: July 8, 2024
• Study Start: March 6, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)