Evaluation of Physical Performance in Ankylosing Spondylitis Patients

NCT04451681 | Completed

• 1 other identifier: BVUFTRAS1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis; Cardiopulmonary exercise test; Aerobic physical capacity; VO2max

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Maximum heart rate

  It is determined by measuring the maximum number of heartbeats observed per minute reached during the KPET.

  One minutes

• Maximum speed

  It is determined by measuring the maximum average distance traveled per minute on the treadmill in meters / minute.

  One minutes

Study Arms (2)

Ankylosing spondylitis

OTHER

A total of 42 patients, who were diagnosed with AS with modified New York Criteria, and who agreed to participate in the study, will be included in this group.

Other: Cardiopulmonary exercise test

Control

OTHER

A total of 42 control participants between the ages of 18-65 who agreed to participate in the study will be included in this group.

Other: Cardiopulmonary exercise test

Interventions

Cardiopulmonary exercise test OTHER

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.

Ankylosing spondylitis; Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (2)

Bezmialem Vakif university

Istanbul, Turkey (Türkiye)

Location

BezmialemVU

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 30, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)