Clinical trial NCT05453071: The Effect of Cognitive Exercise Therapy Approach in Individuals With Systemic Sclerosis
Official title: The Effects of Cognitive Exercise Therapy Approach on Vascularization, Muscle Strength, Functionality, Anti-Inflammatory and Biopsycosocial Status in Individuals With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: Systemic Sclerosis
Biopsychosocial model
BETY
Muscle strength
Functionality
Vascularization
Anti-inflammatory responses
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluation parameters will be applied to the participants twice with an interval of 12 weeks. The first evaluation will be made if the individuals who come to the routine doctor's examination agree to participate in the study. According to being included in one of the two groups as those who decided to attend the BETY sessions that have been going on for 18 years and those who did not agree to attend the sessions; The individuals included in the BETY group (Group 1) will be evaluated on the day of the last exercise session after their participation in the 12-week exercise group, the individuals who do not agree to participate in the BETY sessions but agree to participate in the evaluations at 12-week intervals (Group 2) will be evaluated when they come 12 weeks apart for their routine controls. For patients with systemic sclerosis, the recommendations given routinely in our unit will be made.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis and to present a named exercise model for this disease group with objective results.

Detailed description: Systemic sclerosis is an inflammatory and chronic autoimmune disease. Systemic sclerosis, which was first defined by Hippocrates as thickened skin, can also progress with skin involvement and fibrosis of internal organs. Although the exact pathogenesis of the disease is not understood, it is thought to occur as a result of interactions between factors affecting collagen synthesis, fibrosis, capillary (vasculopathy) changes and immunological mechanisms. The role of inflammation has an important place in the pathogenesis of the disease. One of the most important factors governing the inflammatory process is cytokines. Changes in the response of the cytokines mentioned in systemic sclerosis, respiratory system involvement and related decrease in walking capacity, loss of muscle strength, weakening of hand functions, as well as weakening the psychological and social aspects of a person who is a biopsychosocial being. In addition to local physiotherapy applications such as paraffin applications, exercises for the face and hands, active stretching, exercise approaches such as exercises for aerobic endurance are also beneficial. However, there is no mention of a standardized exercise model, the quality of life of individuals with systemic sclerosis, which is a rare disease, activities of daily living, studies in which the social and psychological aspects of the individual are included in the treatment, and named and defined exercise methods are lacking in the literature. It is seen that studies are generally carried out with scales and functional tests.

Cognitive Exercise Therapy Approach, presents an example of an innovative biopsychosocial model with its own biopsychosocial scale, the basic exercise model of which is core stabilization exercises, including pain management, mood management and sexual information management. For individuals with systemic sclerosis, which is in the group of rare diseases, it is necessary to present the results of the intervention with objective evaluation methods to the literature. In this study, it is aimed to present an exercise model named for this disease group with objective results by examining the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Systemic Sclerosis
* Being between the ages of 18-65
* Regular attendance at the rheumatology outpatient clinic at Hacettepe University
* No medication change in the last 3 months

Exclusion Criteria:

* Having a severe musculoskeletal disability Being diagnosed with pulmonary hypertension
* FVC value below 50%
* History of active infection
* Symptomatic cardiac involvement
* Having a psychiatric disorder
* Pregnancy
* History of active myositis
* Renal failure
* Not being literate

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire (BETY-BQ)
timeFrame: 3 Months
Secondary outcomes:
measure: Modified Rodnan Skin Score (mRSS)
timeFrame: 3 Months
measure: Quality of Life Scale Short Form-36 (SF-36)
timeFrame: 3 Months
measure: Scleroderma Health Assessment Questionnaire (SHAQ)
timeFrame: 3 Months
measure: Modified Hand Mobility in Scleroderma (mHAMIS)
timeFrame: 3 Months
measure: Duruoz Hand Index
timeFrame: 3 Months
measure: Six-minute walk test (6MWT)
timeFrame: 3 Months
measure: Evaluation of muscle strength
timeFrame: 3 Months
measure: Evaluation of vascular structure
timeFrame: 3 Months
measure: Evaluation of anti-inflammatory effects
timeFrame: 3 Months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: