Mustafa Yilmaz
Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)
NCT Number: NCT04835077
Fibromyalgia Syndrome (FMS) is a chronic rheumatic disease characterized by a wide range of symptoms such as widespread muscle pain, fatigue, sleep disturbances, anxiety-depression, impaired balance, falling risk, poor physical condition, cognitive dysfunction, and irritable bowel syndrome.
The aim of the study; It is a comparison of the effectiveness of aerobic exercises and postural stabilization exercises that are structured to reduce the pain severity, fatigue, sleep problems and anxiety-depression levels of patients who are being followed up with a diagnosis of FMS, and to increase the duration of physical activity and quality of life.
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Notify Me25 year–60 year
All sexes
Interventional
Not applicable
Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Structured aerobic exercises (Each session will consist of 50 minutes and will be divided into three parts: 5 minutes of warm-up exercises, 40 minutes of aerobic exercises, 5 minutes of cool down exercises) will be taught in the first session.
Structured postural stabilization exercises (strengthening exercises, balance-coordination exercises, flexibility exercises) will be taught in the first session.
Time frame: change from baseline at 8 weeks
This scale; It measures 10 different characteristics: physical function, feeling unwell, not going to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the sense of well-being, lower scores indicate improvement or less affected by the disease. FIQ is filled by the patient. The maximum possible score for each subtitle is 10. Thus, the total maximum score is 100. While the average FM patient gets 50 points, more severely affected FM patients usually score above 70.
Time frame: change from baseline at 8 weeks
VAS; It is a scale that provides a one-dimensional measurement of pain intensity in different adult populations. It usually consists of a 10 cm long horizontal (HVAS) or vertical (VVAS) line. In measuring the severity of pain; A score of 0 is defined as no pain, a score of 10 as worst pain possible or worst imaginable pain. Although the period of time when pain is questioned varies, the most common time for the patient's pain is the current pain or the pain experienced in the last 24 hours.
Time frame: change from baseline at 8 weeks
The BPI questionnaire is a short, easy-to-apply assessment method that can be used to assess pain. It includes simple 0 to 10 numerical evaluation scales that are easy to understand and translate into different languages. In the short pain inventory, a score of 1-4 of the worst pain is defined as mild pain, 5-6 as moderate pain, and 7-10 as severe pain. Evaluates the severity of pain, localization of pain, medical treatments for pain, and the effect of pain on daily functions, and questions how much pain has been reduced in the last 24 hours or last week. It takes a short time, like 5-10 minutes, to answer all questions.
Time frame: change from baseline at 8 weeks
PSQI is a 19-item self-report scale that evaluates sleep quality and disorder over the past month. Each item of the test is equally scored between 0 and 3. The scale consists of 7 subscales that evaluate subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping pills and daytime functionality loss. The total PSQI score ranging from 0 to 21 is obtained by summing the subscales. A total PSQI score greater than 5 indicates that the individual's sleep quality is insufficient with 89.6% sensitivity and 86.5% specificity, and indicates severe impairment in at least two areas, or moderate deterioration in three areas.
Time frame: change from baseline at 8 weeks
The person indicates how much they agree with each item by choosing numbers from 1 to 7. 1 indicates that they disagree at all, 7 indicates that they agree completely. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue. The total score is calculated by taking the average of 9 items. The cut-off value for pathological fatigue was set at 4 and above. The lower the total score, the less fatigue.
Time frame: change from baseline at 8 weeks
Subjects begin to walk for 2 minutes at their own walking pace in the 21-meter corridor marked from the starting line, wearing their shoes and using their normal walking aids. The lines at both ends of the floor of the corridor indicate where the subjects will turn. The evaluator walks behind the subjects to ensure their safety and to minimize changes in pacing speed while walking. It also keeps time using a digital stopwatch.
Time frame: change from baseline at 8 weeks
It is one of the most common generic measures used to measure quality of life. This scale examines 8 dimensions of health such as physical function, role restrictions, social function, mental health, energy, pain and general perception of health with 36 items. The scale gives a separate total score for each subscale rather than just a single total score, and the scores range from 0 to 100. While 100 points indicate good health, 0 points indicate poor health.
Time frame: change from baseline at 8 weeks
IPAQ Short Form; It consists of nine questions measuring the intensity of physical activity. The questions provide information about physical activities (climbing stairs, walking, shopping, sitting time) in the last 7 days. From these data, the total weekly physical activity level (MET / hour / week) is classified as low, medium and high. Individuals who indicate that they do not have physical activity must have a low physical activity level x ≤ 600 MET / minute / week, and in order to be at an intense or moderate level of physical activity, total physical activity must be attained to a minimum of x ≥ 600-3000 MET / minute / week.
Time frame: change from baseline at 8 weeks
PostureZone mobile application is a new application that makes posture assessment more effective in different environments. Free versions of this easy-to-use and fast application are available on mobile devices. For posture analysis, participants are photographed anteriorly and laterally in front of a flat surface using the device camera. Then, after manually marking the anatomical points on the photograph, the program performs the analysis. With this program, shift and tilt values occurring in the head, shoulder, rib and hip in the anterior and shift and tilt values occurring in the head, shoulder, hip and knee in the lateral can be calculated. If desired, the total shift and tilt values obtained from both angles can be saved. This program, which aims to obtain reliable information through the processing and interpretation of photographic images, can be used in postural assessments thanks to the quantification of linear and angular measurements.
Time frame: change from baseline at 8 weeks
Plank; It is called a type of exercise that develops the leg and chest muscles, especially the abdominal muscles, and is done 45 degrees with the ground. Plank movement improves bodily qualities such as strength, balance and endurance when properly applied. This movement works the entire abdominal muscle. Apart from that, it strengthens the neck, back, waist, chest and front / back leg muscles; Corrects posture disorders. It ensures that the shoulders are back and the breasts are high. The whole body is tightened with the help of the fingertip on the elbows and the head is facing forward. The evaluator keeps time using a digital stopwatch.
Istanbul University - Cerrahpasa
Other
Comparison of the Effectiveness of Structured Aerobic Exercises and Postural Stabilization Exercises in Patients With Fibromyalgia Syndrome
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