Clinical trial NCT04451681: Evaluation of Physical Performance in Ankylosing Spondylitis Patients
Official title: Evaluation of Physical Performance in Ankylosing Spondylitis Patients by Cardiopulmonary Exercise Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis
Cardiopulmonary exercise test
Aerobic physical capacity
VO2max
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Ankylosing spondylitis (AS) can cause serious limitations in individuals' physical performance, as it involves the musculoskeletal system and can cause ankylosis and arthritis in both axial and peripheral joints. Although there are many studies showing these limitations nowadays, there is a need to show these limitations with more objective data with the new technology. Evaluating aerobic physical capacity; Cardiopulmonary Exercise Test (KPET) is frequently used in physical performance analysis today. In this study, the investigators want to observe the physical performance differences between 42 AS patients and 42 control group participants by applying KPET and present the expected performance losses in AS patients in the literature with objective data.

Detailed description: AS is an inflammatory disease of unknown etiology, characterized by marked inflammation in the spinal joints and adjacent structures, leading to progressive and ascending bone fusion in the spine. Although peripheral joint involvement is less, hip and shoulder joints are kept in 1/3 of the cases. Inflammatory lesions can also be seen in extraarticular organs such as eyes and heart. Due to joint involvement, limitations in lung capacity, and other extra-articular involvements, physical performance may decrease in AS patients. Both spinal and peripheral joint involvements and pain caused by chronic inflammatory process can lead patients to a more sedentary lifestyle. Therefore, evaluation of physical performance is important in patients with AS. Although there are some methods based on classical observation in evaluating physical performance, Cardiopulmonary Exercise Test (KPET), where objective data about aerobic capacity can be obtained, has been used frequently in scientific studies in recent years. The data such as oxygen consumption, cardiac parameters and speed of the patient on the treadmill in KPET are analyzed numerically; objective performance values such as maximum oxygen use (VO2max), maximum heart rate, and maximum rate can be achieved. It is possible to evaluate all the individuals to whom these tests are applied according to the normal value ranges in the world more clearly in terms of their physical performance and to reshape the exercise program especially according to the missing parameter. For this reason, these methods are preferred primarily in physical performance evaluation in centers with sufficient facilities.

In the literature, although subjective tests and data on physical performance decrease, studies showing clear numerical data are needed. Therefore, in our study; We aim to evaluate the physical performance of patients by applying KPET in our patients with AS diagnosis. Thus, investigators aim to reveal the physical exercise capacity that may be decreased in this patient group with objective numerical data. In addition, patients data will compare with the control group of similar physical characteristics and age.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of AS with modified New York Criteria (for AS group)
* Being between the ages of 18-65
* Agree to participate in the study

Exclusion Criteria:

* Cardiac disease
* History of stroke
* Asthma or chronic obstructive pulmonary disease
* Deformity that may prevent exercise
* Hypertension
* Unwilling to participate in the study

Primary outcomes:
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Ten minutes
measure: Bath Ankylosing Spondylitis Disease Activation Index (BASDAI)
timeFrame: Ten minutes
measure: Maximum Oxygen use (VO2max)
timeFrame: 60 minutes
measure: Maximum heart rate
timeFrame: One minutes
measure: Maximum speed
timeFrame: One minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif university
city: İstanbul
country: Turkey
facility: BezmialemVU
Study officials:
References: