Clinical trial NCT06398210: Investigation of the Effectiveness of Cognitive Exercise Therapy Approach in Patients With Primary Sjögren's Syndrome
Official title: Investigation of the Effectiveness of Cognitive Exercise Therapy Approach in Patients With Primary Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primer Sjogren's Syndrome
Keywords: Sjogren' Syndrome
biopsychosocial model
health-related quality of life
patient-reported outcome measure
psychosocial intervention
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blinded-Randomized Controlled Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Primary Sjögren's Syndrome
* 18 years or older

Exclusion Criteria:

* 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.

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire (BETY-BQ)
timeFrame: baseline-12. week-6. month
Secondary outcomes:
measure: Central Sensitization Scale
timeFrame: baseline-12. week-6. month
measure: Pain Catastrophizing Scale
timeFrame: baseline-12. week-6. month
measure: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
timeFrame: baseline-12. week-6. month
measure: EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)
timeFrame: baseline-12. week-6. month
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline-12. week-6. month
measure: Primary Sjögren's Syndrome Quality of Life Scale
timeFrame: baseline-12. week-6. month
measure: Multidimensional Fatigue Rating Scale
timeFrame: baseline-12. week-6. month
measure: Turkish Eating Assessment Tool (T-EAT-10)
timeFrame: baseline-12. week-6. month
measure: Yale Swallow Protocol
timeFrame: baseline-12. week-6. month
measure: Test of Mastication and Swallowing Solids
timeFrame: baseline-12. week-6. month
measure: Dysphagia limit
timeFrame: baseline-12. week-6. month
measure: Xerostomia inventory
timeFrame: baseline-12. week-6. month
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Nazli Elif Nacar
Study officials:
References: