Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome

NCT ID: NCT04835077

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Fibromyalgia Syndrome Physiotherapy Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type 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.

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

Group Type EXPERIMENTAL

postural stabilization exercises

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

postural stabilization exercises

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Yilmaz

MSc Physiotherapsit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MUSTAFA YILMAZ

Role: PRINCIPAL_INVESTIGATOR

MSc Physiotherapist

Locations

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Mustafa Yilmaz

Istanbul, Büyükçekmece, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 20461783 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 27682568 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23203795 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 24737367 (View on PubMed)

Other Identifiers

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IstanbulC

Identifier Type: -

Identifier Source: org_study_id

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