NCT04706650

Brief Summary

The investigators aimed to study the associations between exercise capacity and cardiovascular (CV) risk factors in axial spondyloarthritis (axSpA) patients and to determine possible relationships with disease-related variables. Thirty eight patients and 38 controls were recruited in our cross-sectional controlled study. Comprehensive systemic and musculoskeletal examinations were carried out in both of the groups. Cardiovascular risk profile data, ASDAS-CRP, 10-year CV event risk, physical activity levels (IPAQ) were recorded. A maximal treadmill exercise test by Bruce protocol was administered to all participants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

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 15, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2014

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 5, 2021

Last Update Submit

January 10, 2021

Conditions

Keywords

axial spondyloarthritisexercise capacitycardiovascular risk factorsnonradiographic axial spondyloarthritiscardiorespiratory fitness

Outcome Measures

Primary Outcomes (1)

  • Mean difference in exercise capacity of axSpA patients and controls

    maximal METs achieved by a maximal treadmill test by Bruce protocol

    may- october 2014

Secondary Outcomes (1)

  • Mean difference in heart rate recovery of axSpA patients and controls

    may- october 2014

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Thirty eight patients fulfilling the ASAS axial SpA criteria were recruited from the department of Gazi University Physical Medicine and Rehabilitation Rheumatology. 38 control subjects were randomly recruited from local hospital staff with a similar range of sex and age to the patients.

You may qualify if:

  • clinical diagnosis of axial SpA
  • must be able to walk

You may not qualify if:

  • established cardiac disease including structural heart diseases,
  • uncontrolled hypertension,
  • cardiac rhythm disorder,
  • unstable angina pectoris,
  • chronical renal and/or hepatic disease,
  • malignancy,
  • neuromuscular disease
  • musculoskeletal deformity
  • the history of an inflammatory arthritis for control group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist medical doctor

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 13, 2021

Study Start

May 15, 2014

Primary Completion

October 15, 2014

Study Completion

October 15, 2014

Last Updated

January 13, 2021

Record last verified: 2021-01