Effects of Progressive Relaxation Exercises Applied to Patients With Ankylosing Spondylitis on Pain and Fatigue Levels

NCT07058363 | Not Yet Recruiting DMC

• 1 other identifier: GaziantepU
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  0-4-8 weeks later

Study Arms (2)

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.

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.

Interventions

Progressive Relaxation Exercises OTHER

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.

PGE İntervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having AS diagnosis
• Volunteering to participate in the study
• Being over 18 years of age
• Having internet access

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Özlem Ovayolu, Prof. Dr.

  https://www.gaziantep.edu.tr/

  STUDY DIRECTOR

Central Study Contacts

Hilal Benzer, PhD Student

CONTACT

+905051486514; hll.smn.27@gmail.com

Özlem Ovayolu, Prof. Dr.

CONTACT

+905462101692; drovayolu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was planned as a randomized, controlled and experimental study.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 10, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share