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

January 10, 2021 updated by: Ebru Koseoglu Tohma, Muğla Sıtkı Koçman University

Exercise Capacity in Axial Spondyloarthritis and Factors Affecting it: a Cross-sectional Controlled Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference in exercise capacity of axSpA patients and controls
Time Frame: may- october 2014
maximal METs achieved by a maximal treadmill test by Bruce protocol
may- october 2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference in heart rate recovery of axSpA patients and controls
Time Frame: may- october 2014
peak heart rate achieved by maximal exercise minus heart rate at 1st minute of recovery phase
may- october 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2014

Primary Completion (Actual)

October 15, 2014

Study Completion (Actual)

October 15, 2014

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 10, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 10, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • muğla sıtkı koçman university

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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