The Effects Of Progressive Muscle Relaxation Training in Women With Fibromyalgia

The Effects Of Progressive Muscle Relaxation Training in Addition to the Combined Exercise Training in Women With Fibromyalgia

The purpose of the study is to examine the effects of progressive muscle relaxation training given in addition to a combined exercise program in women with fibromyalgia.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: combined exercises and progressive muscle relaxation group; Other: combined exercises group

Detailed Description

Fibromyalgia syndrome is a complex, non-inflammatory pain syndrome characterized by whole-body pain, pain at specific tender points, fatigue, and sleep disturbance

The prevalence of fibromyalgia in the world population varies between 0.2% and 6.4%, and it more frequently affects middle-aged women (30-50 years old). the etiology of fibromyalgia is not fully known.

There are no generally accepted objective clinical findings, radiographic abnormalities, or laboratory tests to assess the presence of fibromyalgia and measure fibromyalgia severity. Therefore, questionnaires measuring patients' subjective responses remain important in the evaluation of fibromyalgia patients until now.

Current treatment recommendations for fibromyalgia strongly support a multifaceted regimen, including patient education, physical therapy, massage, cognitive behavioral therapy, specific pharmacotherapy, restorative sleep, and exercise. Exercise includes aerobic exercise, strengthening and stretching.

Progressive muscle relaxation therapy is an alternative complementary therapy based on the principle of progressive tensing and relaxing of major body muscles to relieve psychological tension. The therapy has no time or space restrictions and does not require any special equipment.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Bolu, Merkez, Turkey, 14030
      • Abant Izzet Baysal University
      • Contact: Eylem TÜTÜN YÜMİN, Professor; Phone Number: +905056763191; Email: eylemtutun78@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women diagnosed with fibromyalgia over the age of 20
• volunteering to participate in the study.

Exclusion Criteria:

• neurological, infectious, endocrine and/or other inflammatory rheumatic diseases
• serious psychiatric illness (schizophrenia, etc.)
• any condition that prevents exercise (advanced heart, respiratory or orthopedic problems)
• Malignancy
• pregnancy
• menopause
• Participating in a physical therapy program (receiving exercise / relaxation training) in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: combined exercises and progressive muscle relaxation group; Participants in this group will be given combined exercises consisting of aerobic exercise, strengthening exercise and stretching exercise, as well as progressive muscle relaxation training. The studies will be carried out under the supervision of a physiotherapist.	Other: combined exercises and progressive muscle relaxation group; Participants in the intervention group will receive a combined exercise program that will last 45-60 minutes, 3 days a week for 8 weeks, and progressive muscle relaxation training that will last 10-15 minutes, under the supervision of a therapist.
Active Comparator: combined exercises group; Participants in this group will be given combined exercises consisting of aerobic exercise, strengthening exercise and stretching exercise. They will rest for 10-15 minutes in a relaxation position only. The studies will be carried out under the supervision of a physiotherapist.	Other: combined exercises group; Patients in the control group will perform a combined exercise consisting of aerobic, strengthening and stretching exercises, which will last 45-60 minutes, 3 days a week for 8 weeks, under the supervision of a physiotherapist. At the end of the combined exercise program, they will rest in the relaxation position for 10-15 minutes each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	The Visual Analog Scale measures pain intensity. It consists of a 10 cm line with two end points representing 0 (no pain) to 10 (pain as bad as possible). The patient marks the current pain level by placing a mark on the line.	Eight weeks
The Pain Catastrophizing Scale	The Pain Catastrophizing Scale is a self-report measure of pain-related catastrophizing thinking. It consists of 13 items on a five-point Likert scale (0 = never to 4 = always ). The total score ranges from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.	Eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Fibromyalgia Impact Scale	The Fibromyalgia Impact Scale assesses the severity of fibromyalgia and its impact on daily function. It contains 10 items: subscores are summed to create a scale from 0 to 100, with a higher score indicating worse symptoms and greater dysfunction.	Eight weeks
COMPASS 31 Scale:	COMPASS 31 scale is a self-assessment tool that investigates autonomic symptoms. The scale contains 31 items assessing six domains of autonomic functions. The total score ranges from 0 (normal) to 100 (worst case).	Eight weeks
Skin Temperature	Peripheral skin temperature will be measured from the medial longitudinal arch with a thermometer. Local skin temperature will be measured with a thermometer from : Right and left lower costal margins, the highest point of the iliac crest (superior side) and the posterior superior iliac spine (inferior side).	Eight weeks
Pulse	Pulse will be measured with a pulse oximeter attached to the fingertip.	Eight weeks
Saturation	Saturation will be measured with a pulse oximeter attached to the fingertip.	Eight weeks
Blood Pressure	The patients' blood pressure will be measured with a sphygmomanometer	Eight weeks
The Respiratory Frequency	The respiratory frequency value will be obtained by multiplying the number of breaths in and out for thirty seconds by two.	Eight weeks
Sit and Reach Test	Flexibility will be evaluated with the sit and reach test. Subjects will be asked to sit on the floor to be tested and place their bare feet flat on the test stand. The subject will be asked to lean forward from the body and will extend his/her hands in front of his body as far forward as he can without bending his knees. The farthest point shown by the fingertip will be measured with the help of a tape measure.	Eight weeks
Grip Strength	Grip Strength is evaluates the strength of the hand muscles used to grasp. In the test procedure, three measurements are made for hand grip strength,and the averages are recorded separately for right and left.	Eight weeks
Pittsburgh Sleep Quality Index	Pittsburgh sleep quality index, consists of 19 items grouped according to seven component scores. Scores on the seven components are then summed to give a global Pittburgh Sleep Quality İndex score ranging from 0 to 21. Scores between 0 and 4 indicate good sleep quality, scores between 5 and 10 indicate poor quality, and above 10 indicate sleep disturbance.	Eight weeks
6-Minute Walk Test	The 6-minute walk test measures the maximum distance in meters that a person can walk as fast as possible over a 6-minute period.	Eight weeks
Perceived Stress Scale	Perceived stress scale, is a 10-item that assesses the amount of perceived psychological stress during the past month. Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". A high score indicates a person's perception of stress is high	eight weeks
The Fatigue Severity Scale	The fatigue severity scale, evaluates how fatigue affects motivation, exercise, physical functioning, performance of tasks, work, family and social life. It is scored on a 7-point Likert scale. A total score is 9-63 , and a score of 36 and above indicates severe fatigue.	Eight weeks

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University
• Investigators: Study Director: Eylem TÜTÜN YÜMİN, Professor, Bolu Abant İzzet Baysal University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): April 12, 2024
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; fibromyalgia; progressive muscle relaxation; combined exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: AIBU-FTR-ETY-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No