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Exercise Capacity, Cardiovascular Risk Factors and Disease-related Variables in Axial Spondyloarthritis

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Completed
CT.gov ID
NCT04706650
Collaborator
(none)
76
Enrollment
5
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    76 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Exercise Capacity in Axial Spondyloarthritis and Factors Affecting it: a Cross-sectional Controlled Study
    Actual Study Start Date :
    May 15, 2014
    Actual Primary Completion Date :
    Oct 15, 2014
    Actual Study Completion Date :
    Oct 15, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Mean difference in exercise capacity of axSpA patients and controls [may- october 2014]

      maximal METs achieved by a maximal treadmill test by Bruce protocol

    Secondary Outcome Measures

    1. Mean difference in heart rate recovery of axSpA patients and controls [may- october 2014]

      peak heart rate achieved by maximal exercise minus heart rate at 1st minute of recovery phase

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Muğla Sıtkı Koçman University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ebru Koseoglu Tohma, specialist medical doctor, Muğla Sıtkı Koçman University
    ClinicalTrials.gov Identifier:
    NCT04706650
    Other Study ID Numbers:
    • muğla sıtkı koçman university
    First Posted:
    Jan 13, 2021
    Last Update Posted:
    Jan 13, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ebru Koseoglu Tohma, specialist medical doctor, Muğla Sıtkı Koçman University
    axial spondyloarthritis
    exercise capacity
    cardiovascular risk factors
    nonradiographic axial spondyloarthritis
    cardiorespiratory fitness
    Additional relevant MeSH terms:
    Spondylitis
    Spondylarthritis

    Study Results

    No Results Posted as of Jan 13, 2021