ExerciseNCT03211559
Clinical Pilates and Aerobic Exercise in Patients With Ankylosing Spondylitis
A study testing Exercise in people with Exercise and Ankylosing Spondylitis, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Exercise, Ankylosing Spondylitis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCyprus
- Study dates
- 20 Dec 2017to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man and woman diagnosed with ankylosing spondylitis .
Who cannot join
- 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
Show all 9Show fewer
- Having a surgery recently
- Doing exercise regularly in last 3 months.
- Having a cardiopulmonary problem which is not under control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Exercise, Ankylosing Spondylitis
- Being tested
- Exercise
- Keywords
- ankylosing spondylitis, clinical pilates exercise, aerobic exercise, functional exercise capacity, pulmonary function
- Medical subject headings
- Motor Activity, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
clinical pilates on mat
| Study group | Role | What they receive |
|---|---|---|
| AEROBİC EXERCİSE (walking on treadmill) | Active comparator | Patients walked on treadmill for 8 weeks, 3 days in a week,30-40 minutes each. Receives: Other: Exercise |
| Aerobic Exercise+Clinical Pilates | Experimental | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline and at the end of 8 weeks
Secondary outcomes (22)
Lateral spinal flexion distance was measured
Lateral spinal flexion distance was measured with a measuring tape and recorded in centimeters.
Measured: At the begining and at the end of 8 weeks.
Lumbal flexion distance was measured
Lumbal flexion distance was measured with a measuring tape and recorded in centimeters.
Measured: At the begining and at the end of 8 weeks.
Tragus to wall distance was measured
Tragus to wall distance was measured with a measuring tape and recorded in centimeters.
Measured: At the begining and at the end of 8 weeks.
Intermalleoler distance was measured
Intermalleoler distance was measured with a measuring tape and recorded in centimeters.
Measured: At the begining and at the end of 8 weeks.
servical rotation was measured
servical rotation was measured with a goniometer and recorded in degrees.
Measured: At the begining and at the end of 8 weeks.
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.
Measured: At the begining and at the end of 8 weeks.
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.
Measured: At the begining and at the end of 8 weeks.
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.
Measured: At the beginning and at the end of 6 weeks
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.
Measured: 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
In this test number of sitting and standing repetitions in sec. will be recorded by the physiotherapist.
Measured: 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.
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.
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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
Measured: At the beginning and at the end of 6 weeks
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.
Measured: 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.
CAREFUSİON MicroRPM device will be used to measure the pressure inside the mouth during deep inspiration and deep expiration.
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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.
Measured: 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 .
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.
Measured: At the beginning and at the end of 6 weeks.
Exercise capacity will be tested by the 6 minute walk test.
Walked distance during 6 minutes will be recorded in meters.
Measured: 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.
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.
Measured: 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.
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).
Measured: 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.
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.
Measured: At the beginning and at the end of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start20 Dec 2017
- Primary completion1 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Öksüz, Eastern Mediterranean University
- Investigators
- Oksuz, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211559
- Sponsor's protocol ID
- GO 16/147
- Status last verified
- Apr 2020
- First submitted
- 19 Oct 2016
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not ethical
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Clinical Pilates Exercise When Applied Together With Aerobic Exercise in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT03211559
- Acronym / sponsor ID
- GO 16/147
- Conditions
- Exercise, Ankylosing Spondylitis
- Keywords
- ankylosing spondylitis, clinical pilates exercise, aerobic exercise, functional exercise capacity, pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AEROBİC EXERCİSE (walking on treadmill) | Active comparator | Other: ExercisePatients walked on treadmill for 8 weeks, 3 days in a week,30-40 minutes each. |
| Aerobic Exercise+Clinical Pilates | Experimental | Other: ExercisePatients 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Man and woman diagnosed with ankylosing spondylitis .
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exerciseclinical pilates on mat | Other | AEROBİC EXERCİSE (walking on treadmill), Aerobic Exercise+Clinical Pilates |
Primary outcome
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.
22 secondary outcomes
Lateral spinal flexion distance was measured
Time frame: 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.
Tragus to wall distance was measured
Time frame: 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.
servical rotation was measured
Time frame: 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.
Flexibility of the upper extremity will be measured with back scratch test.
Time frame: 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
Dynamic balance of the patients will be tested with functional reach test.
Time frame: 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
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
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
Disease activity level be measured with Bath Ankylosing Spondylitis Disease Activity Index.
Time frame: 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
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
Fatigue will be evaluated by the Multidimensional Fatigue Inventory (MFI)
Time frame: 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
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.
Exercise capacity will be tested by the 6 minute walk test.
Time frame: 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: No. Not ethical
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oksuz principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise and Ankylosing Spondylitis, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity will be detected with submaximal exercise testing (modified Bruce protocol). (time frame: Change from Baseline and at the end of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.