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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04706650
Other study ID # mugla sitki koçman university
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2014
Est. completion date October 15, 2014

Study information

Verified date January 2021
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date October 15, 2014
Est. primary completion date October 15, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - clinical diagnosis of axial SpA - must be able to walk Exclusion Criteria: - 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

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mean difference in heart rate recovery of axSpA patients and controls peak heart rate achieved by maximal exercise minus heart rate at 1st minute of recovery phase may- october 2014
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