The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia

NCT05835427 | Completed

• 1 other identifier: Fibromyalgia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

exercise

Outcome Measures

Primary Outcomes (4)

• Fibromyalgia Impact Questionnaire

  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

  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

  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

  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

Study Arms (2)

Fibromyalgia individual

EXPERIMENTAL

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.

Other: Cervical Extensor Stretch

Healthy volunteers

EXPERIMENTAL

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.

Other: Cervical Extensor Stretch

Interventions

Cervical Extensor Stretch OTHER

Fibromyalgia individual: Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.

Fibromyalgia individual

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer

You may not qualify if:

• Known neurological disorder
• Serious orthopedic disorders that will prevent him from exercising
• Cognitive impairment
• Using regular NSAIDs
• Being malnourished and malnourished

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

HAZAL genç

Istanbul, 34070, Turkey (Türkiye)

Location

Related Publications (1)

• Yoo SA, Kim CY, Kim HD, Kim SW. Effects of progressive muscle relaxation therapy with home exercise on pain, fatigue, and stress in subjects with fibromyalgia syndrome: A pilot randomized controlled trial. J Back Musculoskelet Rehabil. 2022;35(2):289-299. doi: 10.3233/BMR-191703.

  PMID: 34151818 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Individuals with fibromyalgia and healthy individuals will be included in the study and the effectiveness of the treatment will be examined. Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 28, 2023
• Study Start: April 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 26, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

TU (1)