Ankylosing SpondylitisNCT07058363
Effects of Progressive Relaxation Exercises Applied to Patients With Ankylosing Spondylitis on Pain and Fatigue Levels
A study testing Progressive Relaxation Exercises in people with Ankylosing Spondylitis, run by University of Gaziantep.
Trial summary
Ankylosing spondylitis (AS) is a chronic rheumatic disease with unique clinical, pathophysiological, radiographic and genetic features, the etiology of which is not known for sure, and is characterized by sacroiliac and spinal joint involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Progressive Relaxation Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having AS diagnosis
- Volunteering to participate in the study
- Being over 18 years of age
- Having internet access
Who cannot join
- Having an orthopedic disability that prevents PGE
- Being pregnant
- Scoring 24 or less from the Mini Mental Test for individuals over 65 years of age
- Wanting to leave the study
- Having any psychiatric problems
- Not using a communication tool that allows online interviews
- Scoring "0" for pain and fatigue
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Ankylosing spondylitis (AS) is a chronic rheumatic disease with unique clinical, pathophysiological, radiographic and genetic features, the etiology of which is not known for sure, and is characterized by sacroiliac and spinal joint involvement. It is reported that this disease affects one in every 200 people, is usually diagnosed years after the onset of symptoms, and negatively affects quality of life. The prevalence of AS is between 0.2% and 1.1%, and symptoms begin before the age of 30 in approximately 80% of cases. The main complaints of patients diagnosed with AS include pain, joint stiffness, fatigue, and functional limitations of various degrees. Functional limitations resulting from inflammation and/or bone formations affect daily life activities, especially the person's ability to participate in leisure and domestic activities, and work productivity, and can limit social roles in the family and society. It is reported in the literature that regular PGE reduces pain and fatigue, facilitates the transition to sleep, and improves quality of life. In this context, this study aimed to evaluate the effect of PGE in reducing pain and fatigue frequently experienced by AS patients and to contribute to symptom management.
Read the detailed description
- Research Design/Model/Type: Method of the study: This study is planned as randomized, controlled and experimental. The universe of the study will consist of all patients who applied to the rheumatology clinic of Gaziantep University Şahinbey Research and Training Hospital, and the sample will consist of patients diagnosed with AS who meet the inclusion criteria according to the power analysis. Patients will be divided into control and PGE groups using a simple random sampling method. It has been determined that the duration/frequency of progressive relaxation exercises is not specific/standardized and the total number of sessions also varies, but PGE is mainly applied for 4-12 weeks, two or three sessions per week. Therefore, in this study, it is planned to apply PGE three times per week for eight weeks, a total of 24 sessions. Place and Time of the Study This study will be conducted in the Gaziantep University Şahinbey Research and Training Hospital Rheumatology polyclinic and clinic. The planned study period is 18 months after obtaining the necessary ethics committee and institutional permissions.
- Study Group/Sample of the Study: In the power analysis, the study titled 'Effect of progressive relaxation exercises on pain perception and quality of life in pregnant women with low back pain' by Baykal (2008) was taken as reference; in order to find a statistically significant expectation that a large effect size (d=1.46) would occur between the 4th week VAS values of the intervention and control groups, the minimum number required in each group was determined as 11 (α=0.05; 1-β=0.90). In order for the intervention and control groups to be balanced, it was decided to include the same number of control groups. However, considering possible losses, it is aimed to include a minimum of 25 patients in each group. Power analysis was performed in Gpower 3.9.1 software.
- Data Collection Tools to be Used in the Project/Research:
- Question Form: This form, prepared by the researchers after examining the relevant literature, consists of questions that question the gender, age, marital status, education level, diagnosis period, and medication use of the individuals.
- Visual Analog Scale (VAS): This scale is a measurement tool with 10 on one end and 0 on the other. The patient is asked to mark a point corresponding to the pain intensity they feel. They are told to accept the time they do not feel any pain as "0" and the time they feel the most severe pain as "10", and the numerical value found shows the patient's pain intensity. The pain levels of the group that will do progressive relaxation exercises will be evaluated with VAS after each PGE. In addition, the pain levels of the patients in the control group will be evaluated with VAS simultaneously with the group that receives PGE.
- Piper Fatigue Scale (PFS): It is a tool consisting of 22 items and four sub-dimensions that subjectively measure one-month fatigue. Each item is rated from weak (1 point) to strong (10 points). The total score is found by summing up the answers to all items and dividing by the number of items. The maximum score that can be obtained from the scale is 10, and the minimum score is 0. An increase in the score means that the fatigue felt by the person is high. The fatigue level of the patients in the group that will perform progressive relaxation exercise and the control group will be evaluated with the PFS every four weeks, at the beginning, the 4th week and the 8th week. Progressive Relaxation Exercise Application Process: Before starting the study, the patients will be informed by the researcher in a room allocated for the study in the outpatient clinic and their permissions will be obtained. Later, in the evaluation made with VAS, patients with pain scores above 0 will be randomised using a simple random number table, PGE and control groups will be randomised. The patients in the PGE group will be informed about the PGE prepared by the Turkish Psychologists Association in the first session by the assistant researcher, using a one-on-one and face-to-face interview technique, in approximately 20-25 minutes. In this interview, individuals will also be told how to tense and relax certain areas of the body and how to complete the session within the scope of PGE, and they will be enabled to do so. At the end of the first interview, the internet access of the patients in the PGE group will be checked, and the patients will be informed about the content of the online interview techniques. Then, for eight weeks, the PGE application will be continued with online interviews to be held by the assistant researcher three days a week and in the morning. Since the duration of PGE will be 20-25 minutes, patients will be divided into groups of five and for individuals who cannot participate in the PGE program planned to be implemented at the patients' homes, repeat sessions will be planned on the same day according to their availability and their participation will be ensured every day. The pain levels of patients who receive PGE will be assessed with VAS after each session and the results will be compared with the control group that did not receive PGE. In addition, the fatigue levels of patients in the PGE group will be assessed with PYE every four weeks, before PGE, in the 4th week and in the 8th week. The fatigue levels of the control group will be assessed with PYE every four weeks, at the beginning, in the 4th week and in the 8th week. At the end of the study, patients in the control group will be taught progressive relaxation exercises and will be allowed to do them if they wish.
- Evaluation of Project/Research Data: Data will be evaluated using the Statistical Package for Social Sciences-SPSS 25.0 package program, and frequency, percentage, mean and standard deviation will be used as descriptive statistics, and Shapiro Wilk test will be used to check the normal distribution of continuous variables. Student t, Chi-square, Mann-Whitney U and Kruskal Wallis, Anova tests will be applied under appropriate conditions to examine the differences between categorical variables. The statistical significance level will be accepted as p<0.05.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Progressive Relaxation Exercises
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation ExercisesOther
Progressive Relaxation Exercises are defined as "a method that provides relaxation throughout the body by voluntary, regular relaxation of large muscle groups in the human body." The main purpose of relaxation exercises is for individuals to feel the difference between tension and relaxation in the muscles and to learn to relax on their own in cases of tension.
| Study group | Role | What they receive |
|---|---|---|
| PGE İntervention | Experimental | PGE will be applied to the patients in the PGE group by the assistant researcher in the first session using a one-on-one and face-to-face interview technique, approximately 20-25 minutes. Then, PGE application will be continued with online interviews to be conducted by the assistant researcher three days a week in the mornings for eight weeks. Pain levels of patients who receive PGE will be assessed with VAS after each session and the results will be compared with the control group that does not receive PGE. In addition, fatigue levels of patients in the PGE group will be assessed with PYS every four weeks before PGE, in the 4th and 8th weeks. Fatigue levels of patients in the control group will be assessed with PYS every four weeks at the beginning, in the 4th and 8th weeks. Receives: Other: Progressive Relaxation Exercises |
| PGE Control | No intervention | The fatigue levels of the control group will be assessed with the PMS every four weeks, at the beginning, week 4 and week 8. At the end of the study, if the patients in the control group wish, they will be taught progressive relaxation exercises and allowed to do them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGE intervention and control
When comparing the results of the PGE(PRE) Intervention and Control Group; A comparison will be made as to whether the applied Progressive Relaxation Exercises have an effect on pain and fatigue or not.
Data will be evaluated using the Statistical Package for Social Sciences-SPSS 25.0 package program, and frequency, percentage, mean and standard deviation will be used as descriptive statistics, and Shapiro Wilk test will be used to check the normal distribution of continuous variables. Student t, Chi-square, Mann-Whitney U and Kruskal Wallis, Anova tests will be applied under appropriate conditions to examine the differences between categorical variables. The statistical significance level will be accepted as p<0.05.
Measured: 8 weeks later
VAS
Visual Analog Scale (VAS): This scale is a measurement tool with 10 on one end and 0 on the other. The patient is asked to mark a point that corresponds to the intensity of pain they feel. They are told to accept the time they do not feel any pain as "0" and the time they feel the most severe pain as "10", and the numerical value found shows the patient's intensity of pain. The pain levels of the group that will do progressive relaxation exercises will be assessed with VAS after each PGE. In addition, the pain levels of the patients in the control group will be assessed with VAS simultaneously with the group that receives PGE.
Measured: 8 weeks later
PİPER
Fatigue Piper Fatigue Scale (PFS): It is a tool consisting of 22 items and four sub-dimensions that subjectively measure one-month fatigue. Each item is rated from weak (1 point) to strong (10 points). The total score is found by summing up the answers to all items and dividing by the number of items. The maximum score that can be obtained from the scale is 10, and the minimum score is 0. An increase in the score means that the fatigue felt by the person is high. The fatigue level of the patients in the group that will do progressive relaxation exercises and the control group will be evaluated with the PFS every four weeks, at the beginning, the 4th week and the 8th week.
Measured: 0-4-8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a randomized, controlled and experimental study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal BENZER, University of Gaziantep
- Investigators
- Özlem Ovayolu, Prof. Dr., Study director, https://www.gaziantep.edu.tr/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058363
- Sponsor's protocol ID
- GaziantepU
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research data will remain confidential by the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Relaxation Exercises Applied to Patients With Ankylosing Spondylitis on Pain and Fatigue Levels
- ClinicalTrials.gov ID
- NCT07058363
- Acronym / sponsor ID
- GaziantepU
- Conditions
- Ankylosing Spondylitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 10 Jul 2025 (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.
Ankylosing spondylitis (AS) is a chronic rheumatic disease with unique clinical, pathophysiological, radiographic and genetic features, the etiology of which is not known for sure, and is characterized by sacroiliac and spinal joint involvement. It is reported that this disease affects one in every 200 people, is usually diagnosed years after the onset of symptoms, and negatively affects quality of life. The prevalence of AS is between 0.2% and 1.1%, and symptoms begin before the age of 30 in approximately 80% of cases. The main complaints of patients diagnosed with AS include pain, joint stiffness, fatigue, and functional limitations of various degrees. Functional limitations resulting from inflammation and/or bone formations affect daily life activities, especially the person's ability to participate in leisure and domestic activities, and work productivity, and can limit social roles in the family and society. It is reported in the literature that regular PGE reduces pain and fatigue, facilitates the transition to sleep, and improves quality of life. In this context, this study aimed to evaluate the effect of PGE in reducing pain and fatigue frequently experienced by AS patients and to contribute to symptom management.
Detailed description
- Research Design/Model/Type: Method of the study: This study is planned as randomized, controlled and experimental. The universe of the study will consist of all patients who applied to the rheumatology clinic of Gaziantep University Şahinbey Research and Training Hospital, and the sample will consist of patients diagnosed with AS who meet the inclusion criteria according to the power analysis. Patients will be divided into control and PGE groups using a simple random sampling method. It has been determined that the duration/frequency of progressive relaxation exercises is not specific/standardized and the total number of sessions also varies, but PGE is mainly applied for 4-12 weeks, two or three sessions per week. Therefore, in this study, it is planned to apply PGE three times per week for eight weeks, a total of 24 sessions. Place and Time of the Study This study will be conducted in the Gaziantep University Şahinbey Research and Training Hospital Rheumatology polyclinic and clinic. The planned study period is 18 months after obtaining the necessary ethics committee and institutional permissions.
- Study Group/Sample of the Study: In the power analysis, the study titled 'Effect of progressive relaxation exercises on pain perception and quality of life in pregnant women with low back pain' by Baykal (2008) was taken as reference; in order to find a statistically significant expectation that a large effect size (d=1.46) would occur between the 4th week VAS values of the intervention and control groups, the minimum number required in each group was determined as 11 (α=0.05; 1-β=0.90). In order for the intervention and control groups to be balanced, it was decided to include the same number of control groups. However, considering possible losses, it is aimed to include a minimum of 25 patients in each group. Power analysis was performed in Gpower 3.9.1 software.
- Data Collection Tools to be Used in the Project/Research:
- Question Form: This form, prepared by the researchers after examining the relevant literature, consists of questions that question the gender, age, marital status, education level, diagnosis period, and medication use of the individuals.
- Visual Analog Scale (VAS): This scale is a measurement tool with 10 on one end and 0 on the other. The patient is asked to mark a point corresponding to the pain intensity they feel. They are told to accept the time they do not feel any pain as "0" and the time they feel the most severe pain as "10", and the numerical value found shows the patient's pain intensity. The pain levels of the group that will do progressive relaxation exercises will be evaluated with VAS after each PGE. In addition, the pain levels of the patients in the control group will be evaluated with VAS simultaneously with the group that receives PGE.
- Piper Fatigue Scale (PFS): It is a tool consisting of 22 items and four sub-dimensions that subjectively measure one-month fatigue. Each item is rated from weak (1 point) to strong (10 points). The total score is found by summing up the answers to all items and dividing by the number of items. The maximum score that can be obtained from the scale is 10, and the minimum score is 0. An increase in the score means that the fatigue felt by the person is high. The fatigue level of the patients in the group that will perform progressive relaxation exercise and the control group will be evaluated with the PFS every four weeks, at the beginning, the 4th week and the 8th week. Progressive Relaxation Exercise Application Process: Before starting the study, the patients will be informed by the researcher in a room allocated for the study in the outpatient clinic and their permissions will be obtained. Later, in the evaluation made with VAS, patients with pain scores above 0 will be randomised using a simple random number table, PGE and control groups will be randomised. The patients in the PGE group will be informed about the PGE prepared by the Turkish Psychologists Association in the first session by the assistant researcher, using a one-on-one and face-to-face interview technique, in approximately 20-25 minutes. In this interview, individuals will also be told how to tense and relax certain areas of the body and how to complete the session within the scope of PGE, and they will be enabled to do so. At the end of the first interview, the internet access of the patients in the PGE group will be checked, and the patients will be informed about the content of the online interview techniques. Then, for eight weeks, the PGE application will be continued with online interviews to be held by the assistant researcher three days a week and in the morning. Since the duration of PGE will be 20-25 minutes, patients will be divided into groups of five and for individuals who cannot participate in the PGE program planned to be implemented at the patients' homes, repeat sessions will be planned on the same day according to their availability and their participation will be ensured every day. The pain levels of patients who receive PGE will be assessed with VAS after each session and the results will be compared with the control group that did not receive PGE. In addition, the fatigue levels of patients in the PGE group will be assessed with PYE every four weeks, before PGE, in the 4th week and in the 8th week. The fatigue levels of the control group will be assessed with PYE every four weeks, at the beginning, in the 4th week and in the 8th week. At the end of the study, patients in the control group will be taught progressive relaxation exercises and will be allowed to do them if they wish.
- Evaluation of Project/Research Data: Data will be evaluated using the Statistical Package for Social Sciences-SPSS 25.0 package program, and frequency, percentage, mean and standard deviation will be used as descriptive statistics, and Shapiro Wilk test will be used to check the normal distribution of continuous variables. Student t, Chi-square, Mann-Whitney U and Kruskal Wallis, Anova tests will be applied under appropriate conditions to examine the differences between categorical variables. The statistical significance level will be accepted as p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was planned as a randomized, controlled and experimental study.
| Arm | Type | Receives |
|---|---|---|
| PGE İntervention | Experimental | Other: Progressive Relaxation ExercisesPGE will be applied to the patients in the PGE group by the assistant researcher in the first session using a one-on-one and face-to-face interview technique, approximately 20-25 minutes. Then, PGE application will be continued with online interviews to be conducted by the assistant researcher three days a week in the mornings for eight weeks. Pain levels of patients who receive PGE will be assessed with VAS after each session and the results will be compared with the control group that does not receive PGE. In addition, fatigue levels of patients in the PGE group will be assessed with PYS every four weeks before PGE, in the 4th and 8th weeks. Fatigue levels of patients in the control group will be assessed with PYS every four weeks at the beginning, in the 4th and 8th weeks. |
| PGE Control | No intervention | –The fatigue levels of the control group will be assessed with the PMS every four weeks, at the beginning, week 4 and week 8. At the end of the study, if the patients in the control group wish, they will be taught progressive relaxation exercises and allowed to do them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having AS diagnosis
- Volunteering to participate in the study
- Being over 18 years of age
- Having internet access
Key exclusion criteria (7 listed)
- Having an orthopedic disability that prevents PGE
- Being pregnant
- Scoring 24 or less from the Mini Mental Test for individuals over 65 years of age
- Wanting to leave the study
- Having any psychiatric problems
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 |
|---|---|---|
| Progressive Relaxation ExercisesProgressive Relaxation Exercises are defined as "a method that provides relaxation throughout the body by voluntary, regular relaxation of large muscle groups in the human body." The main purpose of relaxation exercises is for individuals to feel the difference between tension and relaxation in the muscles and to learn to relax on their own in cases of tension. | Other | PGE İntervention |
Primary outcome
PGE intervention and control
Time frame: 8 weeks later
When comparing the results of the PGE(PRE) Intervention and Control Group; A comparison will be made as to whether the applied Progressive Relaxation Exercises have an effect on pain and fatigue or not. Data will be evaluated using the Statistical Package for Social Sciences-SPSS 25.0 package program, and frequency, percentage, mean and standard deviation will be used as descriptive statistics, and Shapiro Wilk test will be used to check the normal distribution of continuous variables. Student t, Chi-square, Mann-Whitney U and Kruskal Wallis, Anova tests will be applied under appropriate conditions to examine the differences between categorical variables. The statistical significance level will be accepted as p<0.05.
VAS
Time frame: 8 weeks later
Visual Analog Scale (VAS): This scale is a measurement tool with 10 on one end and 0 on the other. The patient is asked to mark a point that corresponds to the intensity of pain they feel. They are told to accept the time they do not feel any pain as "0" and the time they feel the most severe pain as "10", and the numerical value found shows the patient's intensity of pain. The pain levels of the group that will do progressive relaxation exercises will be assessed with VAS after each PGE. In addition, the pain levels of the patients in the control group will be assessed with VAS simultaneously with the group that receives PGE.
PİPER
Time frame: 0-4-8 weeks later
Fatigue Piper Fatigue Scale (PFS): It is a tool consisting of 22 items and four sub-dimensions that subjectively measure one-month fatigue. Each item is rated from weak (1 point) to strong (10 points). The total score is found by summing up the answers to all items and dividing by the number of items. The maximum score that can be obtained from the scale is 10, and the minimum score is 0. An increase in the score means that the fatigue felt by the person is high. The fatigue level of the patients in the group that will do progressive relaxation exercises and the control group will be evaluated with the PFS every four weeks, at the beginning, the 4th week and the 8th week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No. The research data will remain confidential by the researchers.
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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.
Özlem Ovayolu, Prof. Dr. study director
https://www.gaziantep.edu.tr/
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercises in people with Ankylosing Spondylitis, run by University of Gaziantep.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilal Benzer, PhD Student (+905051486514, hll.smn.27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGE intervention and control (time frame: 8 weeks later). The study lists 3 primary outcomes in all. 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 10 Jul 2025.