Systemic Sclerosis Clinical Trial
Official title:
The Effects of Cognitive Exercise Therapy Approach on Vascularization, Muscle Strength, Functionality, Anti-Inflammatory and Biopsycosocial Status in Individuals With Systemic Sclerosis
Verified date | July 2023 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | November 2, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Modified Rodnan Skin Score (mRSS) | A method in which the skin firmness of the person is evaluated by holding the skin between two fingers and looking at the degree of stretching. It is a standard disease activity scoring applied in doctor's examinations for Systemic Sclerosis patients. It evaluates the skin hardness of 17 different parts of the body. 0= normal skin , 1= mild skin thickness, 2= moderate skin thickness, 3= severe skin thickness. A high score indicates increased skin thickness. The total score is scored between 0-51 | 3 Months | |
Secondary | Quality of Life Scale Short Form-36 (SF-36) | SF-36 Quality of Life Scale; It is a 36-item, 11-question scale that allows general health screening with 8 sub-parameters consisting of general health, physical function, social function, pain, emotional well-being, role limitations due to physical health, role limitations due to emotional problems and vitality. It is a generic scale, Items are scored as '0 = worst health condition 100 = best health state'. Each subcategory is scored between 0 and 100 points, with a high score indicating good health. | 3 Months | |
Secondary | Scleroderma Health Assessment Questionnaire (SHAQ) | Dressing and grooming, arising, eating, walking, hygiene, reach, grip and activities are evaluated with 20 items divided into eight areas. The answers given to each question range from "without any difficulty (0)", "with some difficulty (1)", "with much difficulty (2)" and "unable to do (3)". Afterwards, it is requested to show how Raynaud's phenomenon, digital ulcers, intestinal involvement, respiratory and overall disease severity affect the daily activity level on a 15 cm long section. The SHAQ-global score is formed by dividing the sum of the scores of these 8 parameters and 5 items by 13. High score indicates low functionality. | 3 Months | |
Secondary | Modified Hand Mobility in Scleroderma (mHAMIS) | It is a method in which the hand functions of individuals are evaluated by a physiotherapist. It evaluates 4 different hand functions based on observation. | 3 Months | |
Secondary | Duruoz Hand Index | Questionnaire form-18 is a likert-type scale that evaluates different hand functions. It can score between 0-90. A high score means a low hand functions. | 3 Months | |
Secondary | Six-minute walk test (6MWT) | In order to evaluate the aerobic capacity of individuals, they will be toured for 6 minutes at a distance of 30 meters. The average 6MWT is between 400 and 700 meters. | 3 Months | |
Secondary | Evaluation of muscle strength | Muscle strength assessment of knee joint flexor and extensor muscle group will be made with Biodex System Pro3® (Biodex Corp, Shirley, NY, USA) device. Before each measurement, patients will be tested 3 times, and knee flexor and extensor maximal concentric isokinetic muscle strength will be measured at 180°/sec 10 repetitions and 60°/sec 5 repetitions angular speeds, with a 30 sec rest interval after each angular velocity. | 3 Months | |
Secondary | Evaluation of vascular structure | Doppler ultrasonography technique is an ultrasonography method that evaluates the blood flow passing through the lumens of the vascular structures in the body. In this method, flow velocity and resistance measurements can be made in vascular structures by measuring the changing return frequencies of sound waves sent from ultrasound probes to the tissues due to the movement of blood cells flowing in the vessel. In the study, the vascular status of the arteries on the forearm and palmar face will be examined by Doppler ultrasonography. | 3 Months | |
Secondary | Evaluation of anti-inflammatory effects | Examination of the cytokine profiles of the patients will be done before and after the treatment for Group 1, and for Group 2 at the initial and final evaluation. IL-6, IL-10, TNF-a and Irisin values, which are the cytokines that the literature focuses on in the pathophysiology of systemic sclerosis, will be checked by blood analysis with the same measurement units at Hacettepe University Central Laboratory. | 3 Months | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | It is a scale that evaluates anxiety and depression, which are psychological symptoms that can occur with diseases, with 14 items. Each question is scored between 0-3 points and a total score between 0 and 21 points can be obtained. A total score of 0-7 is considered normal, a score of 8-10 is considered borderline abnormal (borderline case), and a score of 11-21 is considered abnormal (case).
0-7 points are normal, 8-10 points are borderline abnormal (borderline case) and 11-21 points are abnormal (case) It is considered. |
3 Months |
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