Exercise CapacityNCT04706650
Exercise Capacity, Cardiovascular Risk Factors and Disease-related Variables in Axial Spondyloarthritis
An observational study of Exercise Capacity and Axial Spondyloarthritis, run by Muğla Sıtkı Koçman University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Capacity, Axial Spondyloarthritis
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2014to 15 Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- clinical diagnosis of axial SpA
- must be able to walk
Who cannot join
- established cardiac disease including structural heart diseases,
- uncontrolled hypertension,
- cardiac rhythm disorder,
- unstable angina pectoris,
- chronical renal and/or hepatic disease,
- malignancy,
Show all 9Show fewer
- neuromuscular disease
- musculoskeletal deformity
- the history of an inflammatory arthritis for control group
About this study
Official title: 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.
- Conditions
- Exercise Capacity, Axial Spondyloarthritis
- Keywords
- axial spondyloarthritis, exercise capacity, cardiovascular risk factors, nonradiographic axial spondyloarthritis, cardiorespiratory fitness
- Medical subject headings
- Axial Spondyloarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in exercise capacity of axSpA patients and controls
maximal METs achieved by a maximal treadmill test by Bruce protocol
Measured: may- october 2014
Secondary outcomes (1)
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
Measured: may- october 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start15 May 2014
- Primary completion15 Oct 2014
- Study completion15 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise CapacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Koseoglu Tohma, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706650
- Sponsor's protocol ID
- muğla sıtkı koçman university
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity in Axial Spondyloarthritis and Factors Affecting it: a Cross-sectional Controlled Study
- ClinicalTrials.gov ID
- NCT04706650
- Acronym / sponsor ID
- muğla sıtkı koçman university
- Conditions
- Exercise Capacity, Axial Spondyloarthritis
- Keywords
- axial spondyloarthritis, exercise capacity, cardiovascular risk factors, nonradiographic axial spondyloarthritis, cardiorespiratory fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 15 May 2014 (actual)
- Primary completion
- 15 Oct 2014 (actual)
- Study completion
- 15 Oct 2014 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- clinical diagnosis of axial SpA
- must be able to walk
Key exclusion criteria (9 listed)
- established cardiac disease including structural heart diseases,
- uncontrolled hypertension,
- cardiac rhythm disorder,
- unstable angina pectoris,
- chronical renal and/or hepatic disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Mean difference in heart rate recovery of axSpA patients and controls
Time frame: may- october 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Capacity and Axial Spondyloarthritis, run by Muğla Sıtkı Koçman University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in exercise capacity of axSpA patients and controls (time frame: may- october 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.