Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Pilates and Aerobic Exercise in Patients With Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211559
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Sevim Öksüz, Eastern Mediterranean University

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).

Condition or disease Intervention/treatment Phase
Exercise Ankylosing Spondylitis Other: Exercise Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Effectiveness of Clinical Pilates Exercise When Applied Together With Aerobic Exercise in Patients With Ankylosing Spondylitis
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 20, 2018


Arm Intervention/treatment
Active Comparator: AEROBİC EXERCİSE (walking on treadmill)
Patients walked on treadmill for 8 weeks, 3 days in a week,30-40 minutes each.
Other: Exercise
clinical pilates on mat

Experimental: Aerobic Exercise+Clinical Pilates
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.
Other: Exercise
clinical pilates on mat




Primary Outcome Measures :
  1. Aerobic capacity will be detected with submaximal exercise testing (modified Bruce protocol). [ Time Frame: Change from Baseline and at the end of 8 weeks ]
    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 :
  1. Lateral spinal flexion distance was measured [ Time Frame: At the begining and at the end of 8 weeks. ]
    Lateral spinal flexion distance was measured with a measuring tape and recorded in centimeters.

  2. Lumbal flexion distance was measured [ Time Frame: At the begining and at the end of 8 weeks. ]
    Lumbal flexion distance was measured with a measuring tape and recorded in centimeters.

  3. Tragus to wall distance was measured [ Time Frame: At the begining and at the end of 8 weeks. ]
    Tragus to wall distance was measured with a measuring tape and recorded in centimeters.

  4. Intermalleoler distance was measured [ Time Frame: At the begining and at the end of 8 weeks. ]
    Intermalleoler distance was measured with a measuring tape and recorded in centimeters.

  5. servical rotation was measured [ Time Frame: At the begining and at the end of 8 weeks. ]
    servical rotation was measured with a goniometer and recorded in degrees.

  6. Spinal mobility of the chest will be measured with chest circumference test. [ Time Frame: At the begining and at the end of 8 weeks. ]
    Measuring tape will be placed at the 4th costa level. the circumference during deep inspiration and deep expiration will be recorded in centimeters.

  7. Flexibility of the upper extremity will be measured with back scratch test. [ Time Frame: At the begining and at the end of 8 weeks. ]
    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.

  8. Static balance of the patients will be tested with single leg stance test. [ Time Frame: At the beginning and at the end of 6 weeks ]

    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.


  9. Dynamic balance of the patients will be tested with functional reach test. [ Time Frame: At the beginning and at the end of 6 weeks ]

    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.


  10. Strength and endurance of the lower extremities will be tested with Chair Sit and Stand Test [ Time Frame: At the beginning and at the end of 6 weeks ]
    In this test number of sitting and standing repetitions in sec. will be recorded by the physiotherapist.

  11. The isometric strength of the back and lower extremity muscles will be measured with a dynamometer. [ Time Frame: At the beginning and at the end of 6 weeks ]
    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.

  12. Functionality of the patients will be measured with Vath Ankylosing Spondylitis Functionality Index. [ Time Frame: At the beginning and at the end of 6 weeks ]
    In that questionnaire patients will be asked to mark the best functionality level in the past week on a 10 cm- visual analogue scale.

  13. Disease activity level be measured with Bath Ankylosing Spondylitis Disease Activity Index. [ Time Frame: At the beginning and at the end of 6 weeks ]

    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


  14. Lung volumes and pulmonary functions will be tested with spirometric function tests. [ Time Frame: At the beginning and at the end of 6 weeks ]
    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.

  15. the strength of pulmonar muscles will be measured with Maximal Inspiratory Presssure and Maximal Expiratory Pressure inside the mouth. [ Time Frame: At the beginning and at the end of 6 weeks ]
    CAREFUSİON MicroRPM device will be used to measure the pressure inside the mouth during deep inspiration and deep expiration.

  16. Fatigue will be evaluated by the Multidimensional Fatigue Inventory (MFI) [ Time Frame: At the beginning and at the end of 6 weeks ]
    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.

  17. Fatigue severity level of the patient will be evaluated by the Fatigue Severity Scale. [ Time Frame: At the beginning and at the end of 6 weeks ]
    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.

  18. Sleep quality level of the patient will be evaluated by the Pitsburg Sleep Quality Index . [ Time Frame: At the beginning and at the end of 6 weeks. ]
    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.

  19. Exercise capacity will be tested by the 6 minute walk test. [ Time Frame: At the beginning and at the end of 6 weeks. ]
    Walked distance during 6 minutes will be recorded in meters.

  20. Quality of life of the patients will be determined with Ankylosing Spondylitis Quality of Life Scale. [ Time Frame: At the beginning and at the end of 6 weeks. ]
    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.

  21. Change in the level of anxiety and depression assessed using Hospital Anxiety and Depression Scale at 6 weeks. [ Time Frame: At the beginning and at the end of 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).

  22. Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks. [ Time Frame: At the beginning and at the end of 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211559


Locations
Layout table for location information
Cyprus
Eastern Mediterranen University
Famagusta, Cyprus, 99450
Sponsors and Collaborators
Eastern Mediterranean University
Investigators
Layout table for investigator information
Principal Investigator: Oksuz Eastern Mediterranean University
Layout table for additonal information
Responsible Party: Sevim Öksüz, Senior Instructor, Eastern Mediterranean University
ClinicalTrials.gov Identifier: NCT03211559    
Other Study ID Numbers: GO 16/147
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not ethical

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sevim Öksüz, Eastern Mediterranean University:
ankylosing spondylitis
clinical pilates exercise
aerobic exercise
functional exercise capacity
pulmonary function
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis