NCT07430189

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

February 18, 2026

Last Update Submit

February 23, 2026

Conditions

Axial Spondyloarthritis (AxSpA)

Keywords

Pulmonary RehabilitationExercise ToleranceDyspneaSpirometryRestrictive Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Change in 6-Minute Walk Distance (6MWD)

    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 Outcomes (4)

  • Change in Forced Vital Capacity (FVC)

    Baseline and Week 8

  • Change in Borg Dyspnea Scale

    Baseline and Week 8

  • Change in BASFI Score

    Baseline and Week 8

  • Change in SF-36 Mental Health Score

    Baseline and Week 8

Study Arms (1)

Multimodal Pulmonary Rehabilitation

EXPERIMENTAL

Patients with radiographic axial spondyloarthritis (r-axSpA) receiving an 8-week structured multimodal pulmonary rehabilitation program.

Behavioral: Multimodal Pulmonary Rehabilitation

Interventions

Multimodal Pulmonary RehabilitationBEHAVIORAL

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.

Multimodal Pulmonary Rehabilitation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University Faculty of Medicine

Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Axial SpondyloarthritisDyspnea

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective, single-arm, open-label pilot study to evaluate the feasibility and efficacy of multimodal pulmonary rehabilitation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 24, 2026

Study Start

May 30, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ANALYTIC CODE

Locations

TU(1)