The Effects Of Progressive Muscle Relaxation Training in Women With Fibromyalgia

NCT06243562 | Not Yet Recruiting

• 1 other identifier: AIBU-FTR-ETY-03
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; progressive muscle relaxation; combined exercise; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• The Fibromyalgia Impact Scale

  Eight weeks

• COMPASS 31 Scale:

  Eight weeks

• Skin Temperature

  Eight weeks

• Pulse

  Eight weeks

• Saturation

  Eight weeks

Study Arms (2)

combined exercises and progressive muscle relaxation group

ACTIVE COMPARATOR

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

combined exercises group

ACTIVE COMPARATOR

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

Interventions

combined exercises and progressive muscle relaxation group OTHER

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.

combined exercises and progressive muscle relaxation group

combined exercises group OTHER

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.

combined exercises group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, Merkez, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Eylem TÜTÜN YÜMİN, Professor

  Bolu Abant İzzet Baysal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: There will be an intervention and control group in the study.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 6, 2024
• Study Start: February 15, 2024
• Primary Completion: April 12, 2024
• Study Completion: February 15, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)