Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome

Not Applicable

Completed

• Conditions: Fibromyalgia Syndrome; Rehabilitation; Physiotherapy
• Interventions: Other: postural stabilization exercises; Other: aerobic exercise

• Registration Number: NCT04835077
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Primary Completion: 2022-04-01
• Study Completion: 2022-09-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Being in the age range of 25-60 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postural Stabilization Exercises	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
Structured Aerobic Exercises	aerobic exercise	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.

Primary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQ)	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

Name	Time	Method
Visual Analogue Scale (VAS)	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.

Trial Locations

Locations (1)

Mustafa Yilmaz; 🇹🇷 Istanbul, Büyükçekmece, Turkey