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临床试验/NCT06398210
NCT06398210已完成不适用

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

Kahramanmaras Sutcu Imam University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
BETY-Biopsychosocial Questionnaire (BETY-BQ)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes Assessor

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

BETY-Biopsychosocial Questionnaire (BETY-BQ)

时间窗: baseline-12. week-6. month

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.

次要结局

  • Central Sensitization Scale(baseline-12. week-6. month)
  • Pain Catastrophizing Scale(baseline-12. week-6. month)
  • Dysphagia limit(baseline-12. week-6. month)
  • Xerostomia inventory(baseline-12. week-6. month)
  • Primary Sjögren's Syndrome Quality of Life Scale(baseline-12. week-6. month)
  • Yale Swallow Protocol(baseline-12. week-6. month)
  • Turkish Eating Assessment Tool (T-EAT-10)(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)
  • Test of Mastication and Swallowing Solids(baseline-12. week-6. month)
  • Multidimensional Fatigue Rating Scale(baseline-12. week-6. month)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazli Elif Nacar

Physioterapist-MSc

Kahramanmaras Sutcu Imam University

研究点 (2)

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