search
Back to results

Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome

Primary Purpose

Fibromyalgia Syndrome, Physiotherapy, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
aerobic exercise
postural stabilization exercises
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Aerobic Exercise, Postural Control, Fibromyalgia

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mustafa Yilmaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Structured Aerobic Exercises

Postural Stabilization Exercises

Control

Arm Description

Following the training on aerobic exercise content and effectiveness; 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. In the following weeks, the aerobic exercise duration of all participants will be increased by 5 minutes compared to the previous week. 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.

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. Breathing exercises Four-way stretching and strengthening of the neck muscles Shoulder girdle stretching and strengthening exercises Hip flexors, hamstring, itb, lumbar extensor stretching and strengthening Lying down exercises in the crawling position Shuttle movement Plank movement Toe taps Bridging Straight leg lift Straight leg raises in side-lying Prone knee flexion

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analogue Scale (VAS)
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.

Full Information

First Posted
April 6, 2021
Last Updated
July 26, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
search

1. Study Identification

Unique Protocol Identification Number
NCT04835077
Brief Title
Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome
Official Title
Comparison of the Effectiveness of Structured Aerobic Exercises and Postural Stabilization Exercises in Patients With Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome, Physiotherapy, Rehabilitation
Keywords
Aerobic Exercise, Postural Control, Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured Aerobic Exercises
Arm Type
Experimental
Arm Description
Following the training on aerobic exercise content and effectiveness; 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. In the following weeks, the aerobic exercise duration of all participants will be increased by 5 minutes compared to the previous week. 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.
Arm Title
Postural Stabilization Exercises
Arm Type
Experimental
Arm Description
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. Breathing exercises Four-way stretching and strengthening of the neck muscles Shoulder girdle stretching and strengthening exercises Hip flexors, hamstring, itb, lumbar extensor stretching and strengthening Lying down exercises in the crawling position Shuttle movement Plank movement Toe taps Bridging Straight leg lift Straight leg raises in side-lying Prone knee flexion
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
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
Intervention Name(s)
postural stabilization exercises
Intervention Description
Structured postural stabilization exercises (strengthening exercises, balance-coordination exercises, flexibility exercises) will be taught in the first session.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
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
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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
Other Pre-specified Outcome Measures:
Title
Brief Pain Inventory (BPI)
Description
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
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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
Title
Fatigue Severity Scale (FSS)
Description
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
Title
2 Minute Walking Test
Description
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
Title
Short Form Health Survey (SF-36)
Description
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
Title
International Physical Activity Questionnaire Short Form (IPAQ Short Form)
Description
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
Title
PostureZone Mobile Application
Description
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
Title
Plank position time
Description
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.
Time Frame
change from baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MUSTAFA YILMAZ
Organizational Affiliation
MSc Physiotherapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mustafa Yilmaz
City
Istanbul
State/Province
Büyükçekmece
ZIP/Postal Code
34500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20461783
Citation
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.
Results Reference
background
PubMed Identifier
27682568
Citation
Walker J. Fibromyalgia: clinical features, diagnosis and management. Nurs Stand. 2016 Sep 28;31(5):51-63. doi: 10.7748/ns.2016.e10550.
Results Reference
background
PubMed Identifier
23203795
Citation
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.
Results Reference
background
PubMed Identifier
24737367
Citation
Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
Results Reference
background

Learn more about this trial

Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome

We'll reach out to this number within 24 hrs