Clinical Pilates and Aerobic Exercise in Patients With Ankylosing Spondylitis

April 9, 2020 updated by: Sevim Öksüz, Eastern Mediterranean University

Investigating the Effectiveness of Clinical Pilates Exercise When Applied Together With Aerobic Exercise in Patients With Ankylosing Spondylitis

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Famagusta, Cyprus, 99450
        • Eastern Mediterranen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline and at the end of 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At the begining and at the end of 8 weeks.
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.
At the begining and at the end of 8 weeks.
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.
At the begining and at the end of 8 weeks.
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.
At the begining and at the end of 8 weeks.
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.
At the begining and at the end of 8 weeks.
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.
At the begining and at the end of 8 weeks.
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.
At the begining and at the end of 8 weeks.
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.
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks
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
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks
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.
At the beginning and at the end of 6 weeks.
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.
At the beginning and at the end of 6 weeks.
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.
At the beginning and at the end of 6 weeks.
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).
At the beginning and at the end of 6 weeks.
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.
At the beginning and at the end of 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eastern Mediterranean University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oksuz, Eastern Mediterranean University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO 16/147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not ethical

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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