The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
July 26, 2023 updated by: hazal genc, Istanbul Medipol University Hospital
Fibromyalgia is a non-articular, chronic rheumatic disease of unknown etiology characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple tender points.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Although the exact etiology cannot be determined in fibromyalgia, it is thought that there are many mechanisms that contribute to the formation of Fibromyalgia.
Evidence for some biochemical, neurohormonal, central nervous system, immunological, psychological and environmental factors that may play a role in the disease has been found.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34070
- Hazal GENÇ
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- Volunteer
- Being diagnosed with fibromyalgia Exclusion Criteria
- Known neurological disorder
- Serious orthopedic disorders that will prevent him from exercising
- Cognitive impairment
- Using regular NSAIDs
- Being malnourished and malnourished
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fibromyalgia individual
Cervical Extensor Stretch, cervical flexor stretch, cervical lateral flexion stretch, thoracic stretch, pectoral stretch, lumbar extensor stretch, posterior capsule stretch, knee flexor stretch, gastro-soleus stretch, quadriceps stretch, cat-camel exercise, shoulder circles, neck flip- tilting the neck to the right and left, relaxation of the abdominal and back muscles, posterior pelvic tilt.
|
Fibromyalgia individual: Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Healthy volunteers : Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
|
|
Experimental: Healthy volunteers
Cervical Extensor Stretch, cervical flexor stretch, cervical lateral flexion stretch, thoracic stretch, pectoral stretch, lumbar extensor stretch, posterior capsule stretch, knee flexor stretch, gastro-soleus stretch, quadriceps stretch, cat-camel exercise, shoulder circles, neck flip- tilting the neck to the right and left, relaxation of the abdominal and back muscles, posterior pelvic tilt.
|
Fibromyalgia individual: Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Healthy volunteers : Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fibromyalgia Impact Questionnaire
Time Frame: 8 weeks
|
In this scale filled by the patient; Physical function, feeling well, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression were measured. With the exception of the well-being trait, low scores indicate recovery or less affliction. Each subheading was asked to be scored between 0-10. Values of 50 points and below were considered as mildly affected, and values above 50 points were considered as severely affected. |
8 weeks
|
|
The Pittsburg Sleep Quality Index
Time Frame: 8 weeks
|
The Pittsburg Sleep Quality Index is a 19-item self-report scale that assesses sleep quality and impairment over the past month.
It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate.
The 18 scored questions of the scale consist of 7 components.
Each component is evaluated over 0-3 points.
The total score of the 7 components gives the scale total score.
The total score ranges from 0 to 21.
A total score greater than 5 indicates "poor sleep quality".
|
8 weeks
|
|
Beck Anxiety Scale
Time Frame: 8 weeks
|
It measures the frequency of anxiety symptoms experienced by the individual.
It is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3.
The individual is asked to mark only one of the "None", "Mild", "Moderate" and "Severe" options for each item.
The total score range is between 0-63.
The high score total indicates the high level of anxiety experienced by the individual.
|
8 weeks
|
|
Fibromyalgia ACR Criterion assessed by Composite the Widespread Pain Scale and the Symptom Severity Scale
Time Frame: 8 weeks
|
It is obtained by adding the Widespread Pain Scale and the Symptom Severity Scale.
The maximum total score here is 19+12=31.
Accordingly, scores below a total of 12 do not suggest fibromyalgia.
Widespread Pain Scale ≥7 and Symptom Severity Scale ≥5.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
July 26, 2023
Study Registration Dates
First Submitted
April 17, 2023
First Submitted That Met QC Criteria
April 27, 2023
First Posted (Actual)
April 28, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fibromyalgia (Alias Study Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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