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Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome

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ClinicalTrials.gov Identifier: NCT04835077
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Mustafa Yilmaz, Istanbul University-Cerrahpasa

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Syndrome Physiotherapy Rehabilitation Other: aerobic exercise Other: postural stabilization exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of Structured Aerobic Exercises and Postural Stabilization Exercises in Patients With Fibromyalgia Syndrome
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Structured Aerobic Exercises

Following the training on aerobic exercise content and effectiveness;

  1. First Week; participants 5 minutes warm-up, 20 minutes of aerobic exercise with 60-70% of maximum heart rate, and 5 minutes of cool down.
  2. In the following weeks, the aerobic exercise duration of all participants will be increased by 5 minutes compared to the previous week.
  3. The duration of the sessions in the 7th and 8th weeks will progressively progress to 40 minutes and the intensity to 75-80% of the maximum heart rate.
Other: aerobic exercise
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.

Experimental: Postural Stabilization Exercises

Exercises; It will consist of postural exercises to be done in prone, supine, side lying, crawling, sitting and standing positions. All exercises will be done in 2 sets per day, the number of repetitions will be determined individually and progressed.

  1. Breathing exercises
  2. Four-way stretching and strengthening of the neck muscles
  3. Shoulder girdle stretching and strengthening exercises
  4. Hip flexors, hamstring, itb, lumbar extensor stretching and strengthening
  5. Lying down exercises in the crawling position
  6. Shuttle movement
  7. Plank movement
  8. Toe taps
  9. Bridging
  10. Straight leg lift
  11. Straight leg raises in side-lying
  12. Prone knee flexion
Other: postural stabilization exercises
Structured postural stabilization exercises (strengthening exercises, balance-coordination exercises, flexibility exercises) will be taught in the first session.

No Intervention: Control
The individuals without any treatment will continue their normal lives and will be included in the study as a control group. Exercise will be given after 8 weeks.



Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire (FIQ) [ 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.


Secondary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ 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.


Other Outcome Measures:
  1. Brief Pain Inventory (BPI) [ 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.

  2. Pittsburgh Sleep Quality Index (PSQI) [ 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.

  3. Fatigue Severity Scale (FSS) [ 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.

  4. 2 Minute Walking Test [ 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.

  5. Short Form Health Survey (SF-36) [ 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.

  6. International Physical Activity Questionnaire Short Form (IPAQ Short Form) [ 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.

  7. Posture Screen Mobile App [ Time Frame: change from baseline at 8 weeks ]
    PostureScreen Mobile® (PostureCo, Inc., Trinity, FL) (PSM) is a new application that makes posture assessment more effective in different settings. It is easy to use, fast and inexpensive. PSM; It can be used by downloading on mobile devices. Using the device camera for posture analysis; Anterior and lateral photographs of the participants are taken in front of a flat floor. Later; After manually marking the anatomical points on the photograph, the program performs the analysis process. With PSM; The shift and tilt values occurring in the head, shoulder, rib and hip anteriorly, and the 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.

  8. Plank position time [ 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being in the age range of 18-60 According to the 2013 American College of Rheumatology (ACR) diagnostic criteria, the Pain Placement Score (AES) is 17 and the Symptomatic Effect Score (SES) is ≥21.
  • FMS symptoms persist for more than 3 months
  • Ability to adapt to exercise
  • Having the ability to use the necessary devices for web-based training

Exclusion Criteria:

  • Any disease that may hinder exercise
  • Finding cardiological problems for aerobic exercises
  • Presence of loss of sense and sense of position
  • Presence of an unhealed fracture or surgical wound Patients with mental / psychotic disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835077


Contacts
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Contact: MUSTAFA YILMAZ +905445455424 fzt.mustafayilmaz@gmail.com

Locations
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Turkey
Mustafa Yilmaz Recruiting
Istanbul, Büyükçekmece, Turkey, 34500
Contact: MUSTAFA YILMAZ, PhD (c)    +905445455424    fzt.mustafayilmaz@gmail.com   
Sub-Investigator: ELA TARAKCI, prof.         
Sub-Investigator: SERDAL UGURLU, prof.         
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: MUSTAFA YILMAZ MSc Physiotherapist
Publications:
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Responsible Party: Mustafa Yilmaz, MSc Physiotherapsit, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04835077    
Other Study ID Numbers: IstanbulC
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mustafa Yilmaz, Istanbul University-Cerrahpasa:
Aerobic Exercise
Postural Control
Fibromyalgia
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases