Investigation of the Effectiveness of Cognitive Exercise Therapy Approach in Patients With Primary Sjögren's Syndrome

NCT06398210 | Completed

• 1 other identifier: KahramanmarasSIU.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effectiveness of the Cognitive Exercise Therapy Approach (BETY in Turkish) in individuals with Primary Sjögren's Syndrome and to compare the effects of this training when applied in groups and individually. H1: BETY training affects at least one of the following: disease activity, pain, and fatigue in individuals with Primary Sjögren's Syndrome. H2: BETY training affects at least one of the quality of life and biopsychosocial status in individuals with Primary Sjögren's Syndrome. H3: BETY training affects the anxiety/depression level in individuals with Primary Sjögren's Syndrome. H4: BETY training affects chewing and swallowing performances in individuals with Primary Sjögren's Syndrome. H5: BETY training given in groups is more effective than individual practice in individuals with Primary Sjögren's Syndrome. Volunteers who meet the inclusion criteria will be placed on the waiting list, the content of all three interventions will be explained to the individuals, and groups will be formed randomly using the sealed envelope method among those who volunteer to participate in all three contents. The three options that will be offered to patients will be 'participation in BETY group sessions', 'participation in individual BETY sessions', and 'following a home program with symptom-oriented exercise recommendations'. The biopsychosocial-based exercise model ("Cognitive Exercise Therapy Approach" (BETY)) to be used in this randomized controlled study is a method developed on individuals with rheumatic diseases. In this method, which can be applied individually or in a group, nociplastic pain, and mood management are combined with exercises. Patients participating in the training received 36 sessions in total; He/she will attend BETY sessions lasting 1 hour, 3 times a week for 12 weeks, in group and individual sessions. Each session will include a warm-up phase, exercise training, and cool-down phases. During these sessions, the physiotherapist plays only an instructive and guiding role. In BETY sessions, exercises will be made more difficult as the person can perform a higher level exercise, in accordance with the loading principle. An exercise band will be added to the exercises that show a progression from closed kinetic chain to open kinetics, following the developments in the patient. In the control group, exercise recommendations will be given as a home program according to the individuals' symptoms. Cognitive Exercise Therapy Approach (BETY) BETY includes mind-body interaction information management, pain management strategies, mood information management through dance therapy/authentic movement, and sexuality information management. BETY first session; After meeting the patient and completing the evaluations, it consists of the steps of analysis of the person's problem, selection of exercise for this problem, replacement of the exercise in function, pain management, and recovery agreement. The basic exercise model used in BETY is function-oriented trunk stabilization exercises. Patients are given information about the 5 features of trunk stabilization (neck, shoulder, rib cage, lumbopelvic region postures and respiratory control), visual imagery, and their control. BETY-nociplastic pain management strategy includes the following steps;

• Physical activity is stopped when there is pain.
• Due to the relationship between pain and central sensitization, the patient questions whether he or she is worried about something. If there is a situation that causes concern, the patient should direct his/her attention away from this point.
• Cognitive restructuring is achieved with positive thoughts instead of negative thoughts as a distraction strategy.
• At the moment of positive thought, it is recommended to do exercises for the painful area. Information management in sexuality means that anxiety about sexuality is also a factor that increases pain. It is added to the sessions with the knowledge that it may be a factor and because it is a subject that cannot usually be talked about. During the "arm openings 1" and "arm openings 2" exercises, during the cognitive restructuring process using positive and negative awareness sentences, is aimed at normalizing these issues in the mind of the individual by including positive and negative sentences about sexuality. In addition, the information will be reinforced by synthesizing the questions asked by the patients during patient education and the pelvic floor muscle training created by trunk stabilization exercises.

Conditions

Primer Sjogren's Syndrome

Keywords

Sjogren' Syndrome; biopsychosocial model; health-related quality of life; patient-reported outcome measure; psychosocial intervention

Outcome Measures

Primary Outcomes (1)

• BETY-Biopsychosocial Questionnaire (BETY-BQ)

  BETY-BQ consists of the following six subtitles that investigate in detail the biopsychosocial dimensions: pain, functionality and fatigue, mood, sociability, sexuality, and sleep quality. This scale consists of 30 items, scored on a 5-point Likert system. Each question is scored as "No never: 0 Yes rarely: 1 Yes sometimes: 2 Yes often: 3 Yes always: 4" and a total score over 30 items. A higher score indicates a poorer biopsychosocial situation.

  baseline-12. week-6. month

Secondary Outcomes (12)

• Central Sensitization Scale

  baseline-12. week-6. month

• Pain Catastrophizing Scale

  baseline-12. week-6. month

• EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)

  baseline-12. week-6. month

• EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)

  baseline-12. week-6. month

• Hospital Anxiety and Depression Scale (HADS)

  baseline-12. week-6. month

Study Arms (3)

Group exercise

EXPERIMENTAL

Patients will be included in group exercise, 36 sessions in total; He/she will attend BETY-group sessions lasting 1 hour, 3 times a week for 12 weeks.

Other: Cognitive Exercise Therapy Approach (BETY)

Individual exercise

EXPERIMENTAL

Patients will be included in individual exercise, 36 sessions in total; He/she will attend BETY-individual sessions lasting 1 hour, 3 times a week for 12 weeks.

Other: Cognitive Exercise Therapy Approach (BETY)

Control

NO INTERVENTION

In the control group, exercise recommendations will be given as a home program according to the symptoms of the individuals.

Interventions

Cognitive Exercise Therapy Approach (BETY) OTHER

Cognitive Exercise Therapy Approach (BETY) BETY includes mind-body interaction information management, pain management strategies, mood information management through dance therapy/authentic movement, and sexuality information management. BETY first session; After meeting the patient and completing the evaluations, it consists of the steps of analysis of the person's problem, selection of exercise for this problem, replacement of the exercise in function, pain management, and recovery agreement. The basic exercise model used in BETY is function-oriented trunk stabilization exercises. Patients are given information about the 5 features of trunk stabilization (neck, shoulder, rib cage, lumbopelvic region postures, and respiratory control), visual imagery, and their control.

Group exercise; Individual exercise

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with Primary Sjögren's Syndrome
• years or older

You may not qualify if:

• Patients with Secondary Sjögren's Syndrome,
• Participated in a regular exercise program in the last 2 months,
• Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
• Having a malignant condition,
• Pregnant individuals,
• Have other conditions that prevent exercise,
• Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Nazli Elif Nacar

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physioterapist-MSc

Model Details: Single Blinded-Randomized Controlled Trial

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: May 13, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)