Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398210
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-30
Brief Title:
Investigation of the Effectiveness of Cognitive Exercise Therapy Approach in Patients With Primary Sjögrens Syndrome
Sponsor:
Kahramanmaras Sutcu Imam University
Organization:
Kahramanmaras Sutcu Imam University
Study Overview
Official Title:
Investigation of the Effectiveness of Cognitive Exercise Therapy Approach in Patients With Primary Sjögrens Syndrome
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the effectiveness of the Cognitive Exercise Therapy Approach BETY in Turkish in individuals with Primary Sjögrens 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 Sjögrens Syndrome
H2 BETY training affects at least one of the quality of life and biopsychosocial status in individuals with Primary Sjögrens Syndrome
H3 BETY training affects the anxietydepression level in individuals with Primary Sjögrens Syndrome
H4 BETY training affects chewing and swallowing performances in individuals with Primary Sjögrens Syndrome
H5 BETY training given in groups is more effective than individual practice in individuals with Primary Sjögrens 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 Heshe 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 therapyauthentic 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 persons 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 hisher 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
H1 BETY training affects at least one of the following disease activity pain and fatigue in individuals with Primary Sjögrens Syndrome
H2 BETY training affects at least one of the quality of life and biopsychosocial status in individuals with Primary Sjögrens Syndrome
H3 BETY training affects the anxietydepression level in individuals with Primary Sjögrens Syndrome
H4 BETY training affects chewing and swallowing performances in individuals with Primary Sjögrens Syndrome
H5 BETY training given in groups is more effective than individual practice in individuals with Primary Sjögrens 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 Heshe 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 therapyauthentic 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 persons 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 hisher 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None