The Effects Of Progressive Muscle Relaxation Training in Women With Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Other: combined exercises groupOther: combined exercises and progressive muscle relaxation group
- Registration Number
- NCT06243562
- Lead Sponsor
- Abant Izzet Baysal University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 42
- Women diagnosed with fibromyalgia over the age of 20
- volunteering to participate in the study.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description combined exercises group 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. combined exercises and progressive muscle relaxation group 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.
- Primary Outcome Measures
Name Time Method The Pain Catastrophizing Scale Eight weeks 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.
Visual Analog Scale Eight weeks 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.
- Secondary Outcome Measures
Name Time Method COMPASS 31 Scale: Eight weeks 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).
Blood Pressure Eight weeks The patients' blood pressure will be measured with a sphygmomanometer
The Respiratory Frequency Eight weeks The respiratory frequency value will be obtained by multiplying the number of breaths in and out for thirty seconds by two.
Grip Strength Eight weeks 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.
The Fibromyalgia Impact Scale Eight weeks 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.
Skin Temperature Eight weeks 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).Pulse Eight weeks Pulse will be measured with a pulse oximeter attached to the fingertip.
Pittsburgh Sleep Quality Index Eight weeks 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.
The Fatigue Severity Scale Eight weeks 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.
Saturation Eight weeks Saturation will be measured with a pulse oximeter attached to the fingertip.
Sit and Reach Test Eight weeks 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.
6-Minute Walk Test Eight weeks 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.
Perceived Stress Scale eight weeks 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
Trial Locations
- Locations (1)
Abant Izzet Baysal University
🇹🇷Bolu, Merkez, Turkey