Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome

NCT04835077 | Completed

• 1 other identifier: IstanbulC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome; Physiotherapy; Rehabilitation

Keywords

Aerobic Exercise; Postural Control; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire (FIQ)

  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.

  change from baseline at 8 weeks

Secondary Outcomes (1)

• Visual Analogue Scale (VAS)

  change from baseline at 8 weeks

Other Outcomes (8)

• Brief Pain Inventory (BPI)

  change from baseline at 8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  change from baseline at 8 weeks

• Fatigue Severity Scale (FSS)

  change from baseline at 8 weeks

Study Arms (3)

Structured Aerobic Exercises

EXPERIMENTAL

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

Postural Stabilization Exercises

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

aerobic exercise OTHER

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 Aerobic Exercises

postural stabilization exercises OTHER

Structured postural stabilization exercises (strengthening exercises, balance-coordination exercises, flexibility exercises) will be taught in the first session.

Postural Stabilization Exercises

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Mustafa Yilmaz

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

Location

Related Publications (4)

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

• Walker J. Fibromyalgia: clinical features, diagnosis and management. Nurs Stand. 2016 Sep 28;31(5):51-63. doi: 10.7748/ns.2016.e10550.

  PMID: 27682568 BACKGROUND

• Vincent A, Lahr BD, Wolfe F, Clauw DJ, Whipple MO, Oh TH, Barton DL, St Sauver J. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken). 2013 May;65(5):786-92. doi: 10.1002/acr.21896.

  PMID: 23203795 BACKGROUND

• Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.

  PMID: 24737367 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• MUSTAFA YILMAZ

  MSc Physiotherapist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Physiotherapsit

Model Details: Randomized Control Study

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 30, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)