Evaluation of Physical Performance in Ankylosing Spondylitis Patients

Ankylosing Spondylitis Clinical Trial

Official title:

Evaluation of Physical Performance in Ankylosing Spondylitis Patients by Cardiopulmonary Exercise Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451681
• Other study ID #: BVUFTRAS1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Cardiopulmonary exercise test
Data such as oxygen consumption, cardiac parameters and speed of the patient are analyzed numerically on the treadmill in the KPET; Objective performance values such as maximum oxygen use (VO2max), maximum heart rate, respiratory capacity, and maximum rate will be obtained.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif university	Istanbul
Turkey	BezmialemVU	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	36-Item Short Form Health Survey (SF-36)	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight sections are: vitality,physical functioning,bodily pain,general health perceptions,physical role,functioning,emotional role functioning,social role functioning and mental health.	Ten minutes
Primary	Bath Ankylosing Spondylitis Disease Activation Index (BASDAI)	The BASDAI or Bath Ankylosing Spondylitis Disease Activity Index is a validated diagnostic test which allows a physician, usually a rheumatologist, to determine the effectiveness of a current drug therapy, or the need to institute a new drug therapy for the treatment of Ankylosing spondylitis (AS).The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS:Fatigue, Spinal pain, Arthralgia (joint pain) or swelling, Enthesitis,Morning stiffness duration, Morning stiffness severity	Ten minutes
Primary	Maximum Oxygen use (VO2max)	VO2 max is the maximum rate of oxygen consumption measured during incremental exercise; that is, exercise of increasing intensity.; The measurement of VO2 max in the laboratory provides a quantitative value of endurance fitness for comparison of individual training effects and between people in endurance training. Maximal oxygen consumption reflects cardiorespiratory fitness and endurance capacity in exercise performance. VO2 max refers to the amount of oxygen a person uses during intense or maximal exercise. Its measurement gives the amount of oxygen consumed per minute for a kilogram of body weight in milliliters.	60 minutes
Primary	Maximum heart rate	It is determined by measuring the maximum number of heartbeats observed per minute reached during the KPET.	One minutes
Primary	Maximum speed	It is determined by measuring the maximum average distance traveled per minute on the treadmill in meters / minute.	One minutes