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Evaluation of Physical Performance in Ankylosing Spondylitis Patients

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cardiopulmonary exercise test
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Ankylosing Spondylitis focused on measuring Ankylosing spondylitis, Cardiopulmonary exercise test, Aerobic physical capacity, VO2max

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif university
  • BezmialemVU

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Ankylosing spondylitis

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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.
Maximum heart rate
It is determined by measuring the maximum number of heartbeats observed per minute reached during the KPET.
Maximum speed
It is determined by measuring the maximum average distance traveled per minute on the treadmill in meters / minute.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2020
Last Updated
March 2, 2022
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04451681
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing spondylitis, Cardiopulmonary exercise test, Aerobic physical capacity, VO2max

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ankylosing spondylitis
Arm Type
Other
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary exercise test
Intervention Description
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.
Primary Outcome Measure Information:
Title
36-Item Short Form Health Survey (SF-36)
Description
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.
Time Frame
Ten minutes
Title
Bath Ankylosing Spondylitis Disease Activation Index (BASDAI)
Description
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
Time Frame
Ten minutes
Title
Maximum Oxygen use (VO2max)
Description
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.
Time Frame
60 minutes
Title
Maximum heart rate
Description
It is determined by measuring the maximum number of heartbeats observed per minute reached during the KPET.
Time Frame
One minutes
Title
Maximum speed
Description
It is determined by measuring the maximum average distance traveled per minute on the treadmill in meters / minute.
Time Frame
One minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Bezmialem Vakif university
City
Istanbul
Country
Turkey
Facility Name
BezmialemVU
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Physical Performance in Ankylosing Spondylitis Patients

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