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Clinical Pilates and Aerobic Exercise in Patients With Ankylosing Spondylitis

Primary Purpose

Exercise, Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Exercise
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise focused on measuring ankylosing spondylitis, clinical pilates exercise, aerobic exercise, functional exercise capacity, pulmonary function

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Man and woman diagnosed with ankylosing spondylitis .

Exclusion Criteria:

  • Any neurological or muscle diseases
  • Inability to continuously attend the exercise program
  • Visual, hearing or mental problems that could prevent communication
  • Using mobility aids
  • Pregnancy
  • Malignity
  • Having a surgery recently
  • Doing exercise regularly in last 3 months.
  • Having a cardiopulmonary problem which is not under control.

Sites / Locations

  • Eastern Mediterranen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

AEROBİC EXERCİSE (walking on treadmill)

Aerobic Exercise+Clinical Pilates

Arm Description

Patients walked on treadmill for 8 weeks, 3 days in a week,30-40 minutes each.

Patients walked on treamill for 8 weeks, 3 days in a week, 30-40 minutes each. Additionally they did clinical pilates exercise for 8 weeks, 3 days in a week.

Outcomes

Primary Outcome Measures

Aerobic capacity will be detected with submaximal exercise testing (modified Bruce protocol).
This test will be done while patients walking on TechnoGym Excitemed Treadmillde. Heart rate will be followed with polars on the chest. Medigraph V2000 device will be used to detect the oxygen amount consumed by the patient during the protocol.

Secondary Outcome Measures

Lateral spinal flexion distance was measured
Lateral spinal flexion distance was measured with a measuring tape and recorded in centimeters.
Lumbal flexion distance was measured
Lumbal flexion distance was measured with a measuring tape and recorded in centimeters.
Tragus to wall distance was measured
Tragus to wall distance was measured with a measuring tape and recorded in centimeters.
Intermalleoler distance was measured
Intermalleoler distance was measured with a measuring tape and recorded in centimeters.
servical rotation was measured
servical rotation was measured with a goniometer and recorded in degrees.
Spinal mobility of the chest will be measured with chest circumference test.
Measuring tape will be placed at the 4th costa level. the circumference during deep inspiration and deep expiration will be recorded in centimeters.
Flexibility of the upper extremity will be measured with back scratch test.
Patients will be asked to rotate their shoulder externally with palms facing their back. Their hand fingers extend while trying to reach the lowest point the other arm internally rotates while trying to reach the highest point. Patients are asked their fingertipsto be closer to each other. If finger tips do not touch each other, the distance between them is recorded in cm assumed as a negative score, if the fingertips touch each other, then the scora is assumed as zero. If they overlap, it is recorded in cm taking as positive score. Three repetitions are performed consecutively and the best score was recorded.
Static balance of the patients will be tested with single leg stance test.
Performed with eyes open and arms on the hips, the participant must stand unassisted on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips. The time passed on one leg will be recorded in seconds. Performed with eyes open and arms on the hips, the participant must stand unassisted on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips. The time passed on one leg will be recorded in seconds.
Dynamic balance of the patients will be tested with functional reach test.
The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. Instruct the patient to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded. Scores are determined by assessing the difference between the start and end position is the reach distance, usually measured in inches. Three trials are done and the average of the last two is noted.
Strength and endurance of the lower extremities will be tested with Chair Sit and Stand Test
In this test number of sitting and standing repetitions in sec. will be recorded by the physiotherapist.
The isometric strength of the back and lower extremity muscles will be measured with a dynamometer.
Back-D (Digital Back Muscle) dynamometer will be used to measure the strength. 3 repetitions will be done and results will be recorded in kg.
Functionality of the patients will be measured with Vath Ankylosing Spondylitis Functionality Index.
In that questionnaire patients will be asked to mark the best functionality level in the past week on a 10 cm- visual analogue scale.
Disease activity level be measured with Bath Ankylosing Spondylitis Disease Activity Index.
The BASDAI consists of a one through 10 scale (one being no problem and 10 being the worst problem) which is used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue Spinal pain Joint pain / swelling Areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments) Morning stiffness duration Morning stiffness severity
Lung volumes and pulmonary functions will be tested with spirometric function tests.
FUTUREMED Discovery Spirometry device will be used. Mouth piece will be placed in patients mouth. Patients will be asked to inhale and exhale 3 times. Then they will be asked to take a deep breath and exhale forcibly as quick as possible. 3 repetitions will be done and the best score will be recorded.
the strength of pulmonar muscles will be measured with Maximal Inspiratory Presssure and Maximal Expiratory Pressure inside the mouth.
CAREFUSİON MicroRPM device will be used to measure the pressure inside the mouth during deep inspiration and deep expiration.
Fatigue will be evaluated by the Multidimensional Fatigue Inventory (MFI)
The MFI is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. It will be filled by the patient.
Fatigue severity level of the patient will be evaluated by the Fatigue Severity Scale.
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. İt will be filled by the patients.
Sleep quality level of the patient will be evaluated by the Pitsburg Sleep Quality Index .
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Patient will be asked to fill this form.
Exercise capacity will be tested by the 6 minute walk test.
Walked distance during 6 minutes will be recorded in meters.
Quality of life of the patients will be determined with Ankylosing Spondylitis Quality of Life Scale.
The ASQoL provides a valuable tool for assessing the impact of interventions for AS and for evaluating models of service delivery. It is well accepted by patients, taking about four minutes to complete, and has excellent scaling and psychometric properties. Patients will be asked to fill the forms.
Change in the level of anxiety and depression assessed using Hospital Anxiety and Depression Scale at 6 weeks.
This scale was filled by the patients. It has no special units. The elevation of the total score indicates the increased anxiety and depression levels (score out of 42).
Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks.
This scale will be formed by the patients. If an individual receives a high score, according to the scale, this result indicates a high level of kinesiophobia. It has not a specific unit.

Full Information

First Posted
October 19, 2016
Last Updated
April 9, 2020
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT03211559
Brief Title
Clinical Pilates and Aerobic Exercise in Patients With Ankylosing Spondylitis
Official Title
Investigating the Effectiveness of Clinical Pilates Exercise When Applied Together With Aerobic Exercise in Patients With Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean 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
The aim of our study is to investigate the effect of Clinical Pilates Exercises on functional status and quality of life when applied together with aerobic exercise in patients with ankylosing spondylitis (AS).
Detailed Description
According to the power analyzes 32 patients, who were diagnosed as Ankylosing spondylitis, will be taken to the study. In the first session their spinal mobility, flexibility, dynamic and static balance, back and lower limb muscle strength, pulmonary functions and pulmonary muscle strength, disease activity level, fatigue level, functional exercise capacity will be assessed to determine functional status by a physiotherapist. Also their quality of life and factors affecting the quality will be assessed. Then the patients will be divided into two exercise groups randomly. Patients in the first group will only do aerobic exercise, patients in the second group will do clinical pilates additional to the aerobic exercise which has the same protocol with the first group. Patients will do the exercise for 8 weeks, 3 times a day individually with a physiotherapist . At the end of the 8 weeks they will be assessed with the same tests again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Ankylosing Spondylitis
Keywords
ankylosing spondylitis, clinical pilates exercise, aerobic exercise, functional exercise capacity, pulmonary function

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
AEROBİC EXERCİSE (walking on treadmill)
Arm Type
Active Comparator
Arm Description
Patients walked on treadmill for 8 weeks, 3 days in a week,30-40 minutes each.
Arm Title
Aerobic Exercise+Clinical Pilates
Arm Type
Experimental
Arm Description
Patients walked on treamill for 8 weeks, 3 days in a week, 30-40 minutes each. Additionally they did clinical pilates exercise for 8 weeks, 3 days in a week.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
clinical pilates on mat
Primary Outcome Measure Information:
Title
Aerobic capacity will be detected with submaximal exercise testing (modified Bruce protocol).
Description
This test will be done while patients walking on TechnoGym Excitemed Treadmillde. Heart rate will be followed with polars on the chest. Medigraph V2000 device will be used to detect the oxygen amount consumed by the patient during the protocol.
Time Frame
Change from Baseline and at the end of 8 weeks
Secondary Outcome Measure Information:
Title
Lateral spinal flexion distance was measured
Description
Lateral spinal flexion distance was measured with a measuring tape and recorded in centimeters.
Time Frame
At the begining and at the end of 8 weeks.
Title
Lumbal flexion distance was measured
Description
Lumbal flexion distance was measured with a measuring tape and recorded in centimeters.
Time Frame
At the begining and at the end of 8 weeks.
Title
Tragus to wall distance was measured
Description
Tragus to wall distance was measured with a measuring tape and recorded in centimeters.
Time Frame
At the begining and at the end of 8 weeks.
Title
Intermalleoler distance was measured
Description
Intermalleoler distance was measured with a measuring tape and recorded in centimeters.
Time Frame
At the begining and at the end of 8 weeks.
Title
servical rotation was measured
Description
servical rotation was measured with a goniometer and recorded in degrees.
Time Frame
At the begining and at the end of 8 weeks.
Title
Spinal mobility of the chest will be measured with chest circumference test.
Description
Measuring tape will be placed at the 4th costa level. the circumference during deep inspiration and deep expiration will be recorded in centimeters.
Time Frame
At the begining and at the end of 8 weeks.
Title
Flexibility of the upper extremity will be measured with back scratch test.
Description
Patients will be asked to rotate their shoulder externally with palms facing their back. Their hand fingers extend while trying to reach the lowest point the other arm internally rotates while trying to reach the highest point. Patients are asked their fingertipsto be closer to each other. If finger tips do not touch each other, the distance between them is recorded in cm assumed as a negative score, if the fingertips touch each other, then the scora is assumed as zero. If they overlap, it is recorded in cm taking as positive score. Three repetitions are performed consecutively and the best score was recorded.
Time Frame
At the begining and at the end of 8 weeks.
Title
Static balance of the patients will be tested with single leg stance test.
Description
Performed with eyes open and arms on the hips, the participant must stand unassisted on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips. The time passed on one leg will be recorded in seconds. Performed with eyes open and arms on the hips, the participant must stand unassisted on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips. The time passed on one leg will be recorded in seconds.
Time Frame
At the beginning and at the end of 6 weeks
Title
Dynamic balance of the patients will be tested with functional reach test.
Description
The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. Instruct the patient to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded. Scores are determined by assessing the difference between the start and end position is the reach distance, usually measured in inches. Three trials are done and the average of the last two is noted.
Time Frame
At the beginning and at the end of 6 weeks
Title
Strength and endurance of the lower extremities will be tested with Chair Sit and Stand Test
Description
In this test number of sitting and standing repetitions in sec. will be recorded by the physiotherapist.
Time Frame
At the beginning and at the end of 6 weeks
Title
The isometric strength of the back and lower extremity muscles will be measured with a dynamometer.
Description
Back-D (Digital Back Muscle) dynamometer will be used to measure the strength. 3 repetitions will be done and results will be recorded in kg.
Time Frame
At the beginning and at the end of 6 weeks
Title
Functionality of the patients will be measured with Vath Ankylosing Spondylitis Functionality Index.
Description
In that questionnaire patients will be asked to mark the best functionality level in the past week on a 10 cm- visual analogue scale.
Time Frame
At the beginning and at the end of 6 weeks
Title
Disease activity level be measured with Bath Ankylosing Spondylitis Disease Activity Index.
Description
The BASDAI consists of a one through 10 scale (one being no problem and 10 being the worst problem) which is used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue Spinal pain Joint pain / swelling Areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments) Morning stiffness duration Morning stiffness severity
Time Frame
At the beginning and at the end of 6 weeks
Title
Lung volumes and pulmonary functions will be tested with spirometric function tests.
Description
FUTUREMED Discovery Spirometry device will be used. Mouth piece will be placed in patients mouth. Patients will be asked to inhale and exhale 3 times. Then they will be asked to take a deep breath and exhale forcibly as quick as possible. 3 repetitions will be done and the best score will be recorded.
Time Frame
At the beginning and at the end of 6 weeks
Title
the strength of pulmonar muscles will be measured with Maximal Inspiratory Presssure and Maximal Expiratory Pressure inside the mouth.
Description
CAREFUSİON MicroRPM device will be used to measure the pressure inside the mouth during deep inspiration and deep expiration.
Time Frame
At the beginning and at the end of 6 weeks
Title
Fatigue will be evaluated by the Multidimensional Fatigue Inventory (MFI)
Description
The MFI is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. It will be filled by the patient.
Time Frame
At the beginning and at the end of 6 weeks
Title
Fatigue severity level of the patient will be evaluated by the Fatigue Severity Scale.
Description
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. İt will be filled by the patients.
Time Frame
At the beginning and at the end of 6 weeks
Title
Sleep quality level of the patient will be evaluated by the Pitsburg Sleep Quality Index .
Description
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Patient will be asked to fill this form.
Time Frame
At the beginning and at the end of 6 weeks.
Title
Exercise capacity will be tested by the 6 minute walk test.
Description
Walked distance during 6 minutes will be recorded in meters.
Time Frame
At the beginning and at the end of 6 weeks.
Title
Quality of life of the patients will be determined with Ankylosing Spondylitis Quality of Life Scale.
Description
The ASQoL provides a valuable tool for assessing the impact of interventions for AS and for evaluating models of service delivery. It is well accepted by patients, taking about four minutes to complete, and has excellent scaling and psychometric properties. Patients will be asked to fill the forms.
Time Frame
At the beginning and at the end of 6 weeks.
Title
Change in the level of anxiety and depression assessed using Hospital Anxiety and Depression Scale at 6 weeks.
Description
This scale was filled by the patients. It has no special units. The elevation of the total score indicates the increased anxiety and depression levels (score out of 42).
Time Frame
At the beginning and at the end of 6 weeks.
Title
Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks.
Description
This scale will be formed by the patients. If an individual receives a high score, according to the scale, this result indicates a high level of kinesiophobia. It has not a specific unit.
Time Frame
At the beginning and at the end of 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Man and woman diagnosed with ankylosing spondylitis . Exclusion Criteria: Any neurological or muscle diseases Inability to continuously attend the exercise program Visual, hearing or mental problems that could prevent communication Using mobility aids Pregnancy Malignity Having a surgery recently Doing exercise regularly in last 3 months. Having a cardiopulmonary problem which is not under control.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oksuz
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranen University
City
Famagusta
ZIP/Postal Code
99450
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not ethical

Learn more about this trial

Clinical Pilates and Aerobic Exercise in Patients With Ankylosing Spondylitis

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