Multimodal Pulmonary Rehabilitation in Radiographic Axial Spondyloarthritis (PuRe-axSpA)

February 23, 2026 updated by: Ender Salbaş, Balikesir University

Multimodal Pulmonary Rehabilitation in Radiographic Axial Spondyloarthritis: A Prospective Pilot Study Addressing Mechanical Restriction and Functional Capacity

This prospective pilot study aims to evaluate the efficacy of a structured 8-week multimodal pulmonary rehabilitation (PR) program specifically designed for patients with radiographic axial spondyloarthritis (r-axSpA). The study assesses the impact of a composite intervention incorporating aerobic conditioning, resistance training, flexibility protocols, and targeted diaphragmatic breathing on functional exercise capacity, dyspnea severity, and pulmonary function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Balıkesir, Turkey (Türkiye)
        • Balikesir University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 75 years.
  • Diagnosis of radiographic axial spondyloarthritis (r-axSpA) confirmed according to the Modified New York Criteria.
  • Clinical stability without acute flares or escalation of systemic therapy in the preceding 3 months.
  • Ability to perform spirometry and ambulate safely.

Exclusion Criteria:

  • Primary respiratory disorders (e.g., COPD and interstitial lung disease) acting as the primary cause of limitation.
  • Significant cardiovascular contraindications to exercise.
  • Pregnancy.
  • Participation in a structured rehabilitation program within the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal Pulmonary Rehabilitation
Patients with radiographic axial spondyloarthritis (r-axSpA) receiving an 8-week structured multimodal pulmonary rehabilitation program.
Behavioral: Multimodal Pulmonary Rehabilitation
An 8-week structured exercise program consisting of three sessions per week (two supervised hospital-based sessions and one structured home-based session). The intervention integrates aerobic conditioning using a treadmill and arm ergometer, resistance and mobility training targeting spinal extension, and specific respiratory muscle training including diaphragmatic and pursed-lip breathing maneuvers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-Minute Walk Distance (6MWD)
Time Frame: Baseline and Week 8
Functional exercise capacity is measured by the total distance walked in 6 minutes, recorded in meters. Higher values indicate better functional exercise capacity (better outcome).
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Forced Vital Capacity (FVC)
Time Frame: Baseline and Week 8
Forced Vital Capacity (FVC) is measured via spirometry and expressed as a percentage of the predicted value. Higher percentages indicate better pulmonary volume and respiratory function (better outcome).
Baseline and Week 8
Change in Borg Dyspnea Scale
Time Frame: Baseline and Week 8
The Modified Borg Dyspnea Scale is used to assess exertional breathlessness. The scale ranges from a minimum of 0 (no dyspnea at all) to a maximum of 10 (maximal dyspnea). Higher scores indicate more severe breathlessness (worse outcome).
Baseline and Week 8
Change in BASFI Score
Time Frame: Baseline and Week 8
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses the degree of functional limitation in daily activities. The scale ranges from a minimum of 0 to a maximum of 10. Higher scores indicate greater functional impairment and disability (worse outcome).
Baseline and Week 8
Change in SF-36 Mental Health Score
Time Frame: Baseline and Week 8
The 36-Item Short Form Health Survey (SF-36) is a health-related quality of life questionnaire. The Mental Health domain is scored from a minimum of 0 to a maximum of 100. Higher scores indicate a more favorable mental health state and better well-being (better outcome).
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balikesir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAP-2018-076
  • 2019/86 (Other Identifier: Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data and the analysis code are available from the corresponding author upon reasonable request.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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