The Effect of Core Exercises on Pelvic Dysfunction, Sexual Dysfunction, Pain, Sleep Quality and Quality of Life in Women With Fibromyalgia

NCT06038214 | Completed

• 1 other identifier: 2022/3421
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

In fibromyalgia patients, exercise is needed to reduce symptoms and to prevent muscle weakness with fatigue and pain. Core exercise retrains and strengthens deep postural spinal muscles such as the multifidus and transverse abdominis by promoting neuromuscular control, maintaining the dynamic stability of the spine and thus reducing pain. By performing core exercises, the pelvic floor, which forms the lower base of the core, is strengthened. Objective: It was planned to investigate the effects of core exercises on pelvic floor dysfunction, sexual dysfunction, pain, sleep quality and quality of life in women with fibromyalgia. Materials and Methods: It was designed as randomized control. Sexually active women with fibromyalgia syndrome between the ages of 18-65 will be included in the study. After the patients are selected from the relevant stage with the improbable random sampling method, the patients who accept to participate in the study and meet the inclusion criteria will be assigned to one of the groups in which the core exercise or home program is applied. Evaluations will be evaluated for each group before starting the exercise program and 1 day after the last session, following the completion of 2 sessions per week for 8 weeks. Pain Visual Analog Scale; fibromyalgia impact level Revised Fibromyalgia Impact Questionnaire (FIQR); pelvic floor dysfunction Pelvic Floor Impact Questionnaire (PFIQ); sexual dysfunction Female Sexual Function Scale; sleep quality: Pittsburgh Sleep Quality Index; short quality of life It is planned to be evaluated with Form-36(SF-36). Conclusion: The effects of core exercises on pelvic floor dysfunction, sexual dysfunction, pain, sleep quality and quality of life will be evaluated and interpreted by comparing the evaluations before and after treatment and between groups.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (5)

• Pelvic Floor Impact Questionnaire (PFIQ )

  Pelvic floor assessment: Pelvic Floor Impact Questionnaire (PFIQ) Pelvic Floor Impact Questionnaire) will be used for measurement. PFIQ is a pelvic floor quality of life questionnaire used to assess the effects of bowel, bladder, and/or pelvic symptoms on an individual's activities of daily living, social relationships, and emotions.

  8 weeks

• Female Sexual Dysfunction Scale

  Sexual Dysfunction: Will be measured by the Female Sexual Dysfunction Scale. The scale consists of 19 questions. Each question has six options that need to be answered, and each item is scored from zero to five. In the structure of the scale; There are six sub-dimensions: desire, arousal, lubrication, orgasm, satisfaction, and pain. The person scores between 4 and 95 on the scale. Permission has been obtained to use the survey.

  8 weeks

• Visual Analog Scale (VAS)

  Pain: Regional neck and back pain during rest and activity will be evaluated with the help of Visual Analog Scale (VAS). The VAS is a 10cm scale that evaluates 0 points as "no pain" and 10 points as "the worst pain imaginable".

  8 weeks

• Pittsburgh Sleep Quality Index

  Sleep Quality: Will be measured by the Pittsburgh Sleep Quality Index. Identification of good and bad sleep and assessment of sleep quality. It consists of a total of 24 questions, 19 of which are self-assessment and 5 of which are answered by the person's spouse or roommate. The questions are collected in 7 sub-scales. These; subjective sleep quality, sleep delay, sleep duration, habitual sleep activity, sleep disturbance, sleep medication use and daytime dysfunction. Each subscale is scored between 0-3 points. The total score is from 0-21. Questions asked to an individual's spouse or roommate are not included in the calculation. Permission has been obtained to use the survey

  8 weeks

• Short Form-36 (SF-36)

  Quality of life: Short Form-36 (SF-36) scale will be used. Evaluation of the quality of life of SF-36 developed for this purpose. Validity and reliability studies were conducted in Turkey. SF-36 is used to compare general and specific populations, demonstrate the health benefits of different treatments, and monitor patients. In the evaluation of KF-36, which consists of a total of 36 items, the last 4 weeks are taken into account. Due to the release of the SF-36 v2.0, the use of v1.0 does not require permission.

  8 weeks

Study Arms (2)

core exercises grup

Core Exercise Group Exercises The exercise program was planned as warm-up, core exercises and cool-down periods, 2 days a week, 30 minutes a day and 8 weeks. In the warm-up and cool-down program, each exercise was planned as 3 sets of 10 seconds. The first 2 weeks of exercises were planned as 6 repetitions, the next 2 weeks the exercises 10 repetitions and the last 4 weeks the exercises were planned as 12 repetitions.

Other: core exercises

home exercises grup

At the beginning of the study, it is planned to give a home exercise program for 30 minutes, 2 days a week for 8 weeks, with information and teaching home exercises at the beginning of the study. The content of the home exercise program will be therapeutic exercises, stretching and relaxation exercises. Evaluations will be evaluated for each group at the same time of the day before the exercise program starts and 1 day after the last session after completing 2 sessions a week for 8 weeks.

Other: home exercises

Interventions

core exercises OTHER

1.5 minutes walking 2. Stretching exercise * hallowing in supine and side lying position * Bracing in supine and side lying position * Bracing on the prone and forearms * Bracing in the crawling position * Bracing in laptop, half-lap and standing position * Heel slide exercise * Bridge building exercise * Unilateral limb flexion exercise in crawling position * Reciprocal heel slide exercise in supine position * Bilateral lower extremity lifting exercise * Unilateral lower extremity flexion in bridging position * Side bridging exercise with knees extended * Unilateral lower extremity extension in crawling position * Contralateral lower and upper extremity lift in the crawling position * Straight and oblique trunk flexion * Straight and oblique trunk flexion with hip and knee flexed to 90° * bracing on the ball * squat * bracing while walking

Also known as: exercises

core exercises grup

home exercises OTHER

Right and left rotation of the head * lateral flexion of the head * Flexion and extension of the head * Stretching the neck extensors * pectoral stretch * Stretching the hip extensors * Hamstrig stretching * Stretching the lumbar extensors * Abdominal strengthening * bridging * Hip abduction strengthening * hip extension strengthening * Upper extremity resistant flexion * Upper extremity resistant abduction * Upper extremity relaxation exercise * Capsule stretching * Stretching the hip flexors * Stretching the lower extremity adductors * relaxation exercise

home exercises grup

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

fibromiyalgia

You may qualify if:

• Be between the ages of 18 and 60 with a previous diagnosis of fibromyalgia
• Symptoms last longer than 3 months
• Being sedentary (not doing physical activity at least 3 days a week in the last 3 months)
• being sexually active
• To voluntarily accept participation in an exercise program 2 days a week for 8 weeks,

You may not qualify if:

• Using psychotropic medication in the last 1 month
• Known central or peripheral nervous system disease, progressive neurological damage
• Presence of any cardiovascular pathology
• Presence of uncontrolled hypertension
• Presence of any musculoskeletal system disease other than fibromyalgia
• Pregnancy
• Presence of cognitive problems that will affect cooperation
• Volunteer's request to leave
• Failure to continue training sessions

Sponsors & Collaborators

• Inonu University: lead
• Burcu Talu: collaborator

Study Sites (1)

Inonu Unıversity

Malatya, Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: msc physiotherapist

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 14, 2023
• Study Start: June 20, 2022
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: June 8, 2025

Record last verified: 2024-03

Locations

TU (1)