The Effect of Cognitive Exercise Therapy Approach in Individuals With Systemic Sclerosis

NCT ID: NCT05453071

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2022-11-02

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.

Conditions

Systemic Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

BETY Group

Since 2004, group exercise sessions have been organized as a routine form of treatment for individuals diagnosed with rheumatism in the Department of Physiotherapy and Rehabilitation of Hacettepe University. 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.

Group Type: ACTIVE_COMPARATOR

Cognitive Exercise Therapy Approach (BETY)

Intervention Type: OTHER

BETY, based on function-oriented core stabilization exercises, will be applied in patients with systemic sclerosis. This exercise model includes pain management strategies, dance therapy-authentic movement. Function-oriented core stabilization exercises have the feature of being made difficult against gravity according to the person's ability to do. Initial exercises start from the stage where the distal segment of the extremity is on the ground, called closed-kinetic. This level, which is quite easy, becomes more difficult following the success of the individual. It can be started from the mat level and progressed by modifying it with theraband and exercise ball. It is used at the beginning and end of dance therapy and authentic movement sessions. In the session, cognitive restructuring technique is used to break the vicious cycle of pain-emotional-spasm during exercise. This exercise model is the main rehabilitation approach of the Rheumatological Rehabilitation Unit.

Control Group

Individuals (Group 2), who do not agree to participate in BETY sessions but agree to participate in evaluations with 12-week intervals, will be evaluated when they come for their routine check-ups at 12-week intervals, and recommendations given routinely.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Exercise Therapy Approach (BETY)

BETY, based on function-oriented core stabilization exercises, will be applied in patients with systemic sclerosis. This exercise model includes pain management strategies, dance therapy-authentic movement. Function-oriented core stabilization exercises have the feature of being made difficult against gravity according to the person's ability to do. Initial exercises start from the stage where the distal segment of the extremity is on the ground, called closed-kinetic. This level, which is quite easy, becomes more difficult following the success of the individual. It can be started from the mat level and progressed by modifying it with theraband and exercise ball. It is used at the beginning and end of dance therapy and authentic movement sessions. In the session, cognitive restructuring technique is used to break the vicious cycle of pain-emotional-spasm during exercise. This exercise model is the main rehabilitation approach of the Rheumatological Rehabilitation Unit.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Orkun Tüfekçi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Go 19/191

Identifier Type: -

Identifier Source: org_study_id