Assessment of Cardiorespiratory Fitness in Spondylarthritis

NCT05926453 | Active Not Recruiting

• 1 other identifier: DS-00772
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Spondyloarthritis is a chronic inflammatory joint disease that affects the spine and sacroiliac joints. Most untreated patients eventually experience impaired mobility of the spine, pain and reduced physical function. Exercise is a cornerstone in the treatment of patients with spondylarthritis and it has been shown that high intensity exercise is just as effective in reducing disease activity as immunosuppressive medication. Additionally, patients with spondylarthritis have increased risk of cardiovascular disease both due to traditionally risk factors (obesity, high blood pressure etc) but also due to chronic inflammation. A maximal cardiopulmonary exercise test (CPET) is a measure of cardiorespiratory fitness that can be used to show progression of the exercise and which also is correlated to all-cause mortality and life expectancy. The investigators will validate an indirect maximal CPET against the gold standard with direct gas exchange measurements in patients with spondylarthritis. The indirect test is less time consuming, requires less sophisticated equipment, has lesser requirements to test personnel and facilities, and has less expenditures than the direct test. With a validated indirect maximal CPET the test of cardiorespiratory fitness will be more accessible for patients with spondylarthritis both in-hospital but also municipal.

Conditions

Spondylarthritis

Keywords

exercise test; validation study

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between VO2peak direct gas measurement and estimated VO2peak ml/minute/kilogram using the modified Balke protocol

  Comparison between the gold standard measurement og cardiorespiratory fitness and the indirect measurements.

  2 hours

Secondary Outcomes (9)

• Correlation coefficient between VO2peak direct gas measurement and estimated VO2peak ml/minute using the modified Balke protocol

  2 hours

• Performance validation criteria

  2 hours

• Performance validation criteria

  2 hours

• Performance validation criteria

  2 hours

• Performance validation criteria

  2 hours

Study Arms (1)

Maximal CPET

One maximal cardiopulmonary exercise test with simultaneous registration of direct gas measurements and the variables necessary for estimated cardiorespiratory fitness.

Other: Maximal cardiorespiratory exercise test

Interventions

Maximal cardiorespiratory exercise test OTHER

previously described

Maximal CPET

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with spondylarthritis diagnosed by a rheumatologist

You may qualify if:

• Adult patients 18-70 years old with axial SpA according to ASAS criteria

You may not qualify if:

• The American College of Sports Medicine (ACSM) have listed the following contradictions to CPET and participants with absolute or relative contradictions will be excluded.
• Absolute contraindications to max CPET: acute myocardial infarction within 2 days, unstable angina, uncontrolled cardiac arrhythmia with hemodynamic compromise, active endocarditis, symptomatic severe aortic stenosis, decompensated heart failure, acute pulmonary embolism, pulmonary infarction, or deep venous thrombosis, acute myocarditis or pericarditis, suspected or known aneurysm, acute systemic infection accompanied by fever, body aches, or swollen lymph glands.
• Relative contraindications to max CPET: Left main coronary stenosis, moderate to severe aortic stenosis, arrhythmia (tachydysrhythmia or bradyarrhythmia), recent stroke or transient ischemic attack, resting hypertension with blood pressure systolic \> 200 mmHg and/or diastolic \> 115 mmHg, uncorrected medical conditions, such as significant anaemia, important electrolyte abnormalities imbalance, and hyperthyroidism, uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis or myxoedema) and chronic infectious disease (e.g. mononucleosis, hepatitis, AIDS).

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Birgitte Nellemann, MD PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 3, 2023
• Study Start: October 17, 2023
• Primary Completion: July 9, 2024
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)