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

NCT05453071 | Completed

• 1 other identifier: Go 19/191
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis

Keywords

Systemic Sclerosis; Biopsychosocial model; BETY; Muscle strength; Functionality; Vascularization; Anti-inflammatory responses

Outcome Measures

Primary Outcomes (1)

• BETY-Biopsychosocial Questionnaire (BETY-BQ)

  It is a 5-point Likert-type scale consisting of 30 questions developed with individuals with rheumatism. It is a practical scale that evaluates individuals in terms of fatigue and functionality, sleep, mood, sexuality, pain and sociability. Each question is scored as "0= never, 1=yes rarely, 2=yes sometimes, 3=yes often 4=yes always" and gives a total score over 30 items. A high score means a low biopsychosocial level. The total score is scored between 0-120

  3 Months

Secondary Outcomes (10)

• Modified Rodnan Skin Score (mRSS)

  3 Months

• Quality of Life Scale Short Form-36 (SF-36)

  3 Months

• Scleroderma Health Assessment Questionnaire (SHAQ)

  3 Months

• Modified Hand Mobility in Scleroderma (mHAMIS)

  3 Months

• Duruoz Hand Index

  3 Months

Study Arms (2)

BETY Group

ACTIVE COMPARATOR

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.

Other: Cognitive Exercise Therapy Approach (BETY)

Control Group

NO INTERVENTION

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.

Interventions

Cognitive Exercise Therapy Approach (BETY) 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.

BETY Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 34349, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 12, 2022
• Study Start: February 2, 2022
• Primary Completion: March 15, 2022
• Study Completion: November 2, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

TU (1)