NCT06739369

Brief Summary

The aim of this study was to investigate the relationship between arterial stiffness and pulmonary and extrapulmonary features in patients with ankylosing spondylitis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

November 27, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

August 6, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 12, 2025

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 27, 2024

Last Update Submit

August 10, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Arterial stiffness

    It will be evaluated with brachial pulse waves.

    1st day

  • Respiratory muscle strength

    Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using a portable mouth pressure device.

    1st day

  • Respiratory muscle endurance

    This will be evaluated with increased workload testing.

    1st day

  • Exercise capacity

    Exercise capacity will be assessed with 6 minute walk test.

    1st day

  • Peripheral muscle strength

    Hand grip strength will be assessed with a grip dynamometer.

    1st day

  • Muscle function

    It will be evaluated with one-minute sit to stand test

    1st day

Secondary Outcomes (6)

  • Physical activity

    1st day

  • Forced vital capacity

    1st day

  • Forced expiratory volume in one second

    1st day

  • Forced expiratory volume in one second/forced vital capacity ratio

    1st day

  • Peak expiratory flow

    1st day

  • +1 more secondary outcomes

Study Arms (1)

Ankylosing spondylitis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed up with a diagnosis of ankylosing spondylitis will be included.

You may qualify if:

  • Diagnosis of ankylosing spondylitis according to ASAS diagnostic criteria
  • Being aged 18-65
  • Stable medication use for at least 3 months
  • Voluntary participation in the study

You may not qualify if:

  • Having uncontrolled cardiopulmonary disease
  • Being pregnant
  • Having undergone recent surgery
  • Presence of malignancy
  • Failure to perform to assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 18, 2024

Study Start

August 6, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 12, 2025

Record last verified: 2024-11

Locations