Kinesthetic Brain and Telerehab Pilates for Cognitive and Functional Outcomes in Women With Fibromyalgia

NCT ID: NCT07141550

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2026-09-15

Brief Summary

Fibromyalgia is a chronic pain syndrome often accompanied by fatigue, psychological problems, and cognitive dysfunction, leading to reduced quality of life. Telerehabilitation-based Pilates has been shown to improve symptoms and function in fibromyalgia, while kinesthetic brain exercises may enhance cognitive performance through neuroplasticity. This study aims to evaluate the effects of adding kinesthetic brain exercises to telerehabilitation-based Pilates on cognitive functions, symptom management, functional performance, and quality of life in women with fibromyalgia.

Detailed Description

Fibromyalgia (FM) is a chronic and widespread pain syndrome affecting the musculoskeletal system. It is the second most common rheumatic disease worldwide and is associated with pain, fatigue, sleep disturbance, morning stiffness, psychological problems, and cognitive dysfunction. These symptoms contribute to physical disability, reduced physical activity, and difficulties in social and occupational life. The pathophysiology of FM is not clearly defined, but central sensitization is thought to play a key role. The unclear etiology and the limited effectiveness of existing treatment methods make the management of FM challenging and highlight the need for multidisciplinary treatment approaches.

Cognitive impairment, commonly referred to as "fibro-fog," is observed in more than half of individuals with FM. It negatively affects attention, perception, and executive functions, thereby reducing daily functioning and overall quality of life. For this reason, therapeutic strategies targeting cognitive functions in FM have gained increasing importance. Neuroplasticity, the brain's ability to adapt to environmental changes and experiences, is a promising mechanism for improving cognitive functions. Regular exercise has been shown to stimulate neuroplasticity and enhance cognition.

In recent years, telerehabilitation has become a valuable treatment option, especially for individuals with chronic diseases who cannot access regular healthcare services. It provides an effective, safe, and accessible method for assessment, intervention, education, and monitoring, while also saving time and cost. Telerehabilitation has been demonstrated to improve pain, functional capacity, quality of life, and treatment adherence in patients with FM.

Exercise therapy remains a cornerstone in FM management. Pilates, as a mind-body exercise focusing on controlled movement, stretching, and breathing, aims to strengthen core muscles, improve posture, flexibility, and balance, and enhance overall physical and psychological well-being. It can be adapted to individual needs, making it a suitable component of multidisciplinary treatment programs. Clinical studies indicate that Pilates is effective in reducing pain, improving muscle strength, posture, and function, and enhancing quality of life in FM.

Kinesthetic brain exercises, which combine movement and mental tasks, are designed to target cognitive processes such as attention, memory, and problem solving. By supporting motor learning and neuroplasticity, they may improve synaptic reorganization and enhance cognitive as well as physical performance. Given that FM affects both mental and physical functioning, kinesthetic brain exercises may represent a promising complementary approach.

To date, no studies have investigated the combined effects of kinesthetic brain exercises and telerehabilitation-based Pilates in women with fibromyalgia. This study aims to evaluate the effectiveness of adding kinesthetic brain exercises to a telerehabilitation-based Pilates program on cognitive functions, symptom management, functional performance, and quality of life in women with FM.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

İntervention group

Clinical pilates and kinesthetic brain exercises will be applied to this group

Group Type: OTHER

Clinical Pilates Group

Intervention Type: OTHER

Participants will be introduced to the principles of Pilates, the workout program, and its five key elements: neutral spine, lumbopelvic and scapular stabilization, focus, and breathing. Clinical Pilates sessions will be held twice weekly for 8 weeks, 60 minutes each, via synchronous telerehabilitation (Zoom/WhatsApp). Each session includes a 10-minute warm-up, 40 minutes of Pilates exercises, and a 10-minute cool-down. The physiotherapist will provide visual and verbal guidance to ensure correct posture and breathing. Exercises start with 6-8 repetitions in the first week, increasing progressively according to participant ability and advancing to higher-level positions.

Kinesthetic Brain Exercises Group

Intervention Type: OTHER

16 sessions, approximately 40 minutes each, will be administered twice a week for eight weeks by a physical therapist via video chat programs such as Zoom or WhatsApp. Kinesthetic brain exercises consist of three phases: a warm-up phase, an exercise phase, and a cool-down phase. The warm-up and cool-down phases consist of hand-eye coordination and relaxation exercises. The exercise phase consists of independent and dependent movements, as well as a combination of both.

Control Group

group to receive clinical Pilates

Group Type: OTHER

Clinical Pilates Group

Intervention Type: OTHER

Participants will be introduced to the principles of Pilates, the workout program, and its five key elements: neutral spine, lumbopelvic and scapular stabilization, focus, and breathing. Clinical Pilates sessions will be held twice weekly for 8 weeks, 60 minutes each, via synchronous telerehabilitation (Zoom/WhatsApp). Each session includes a 10-minute warm-up, 40 minutes of Pilates exercises, and a 10-minute cool-down. The physiotherapist will provide visual and verbal guidance to ensure correct posture and breathing. Exercises start with 6-8 repetitions in the first week, increasing progressively according to participant ability and advancing to higher-level positions.

Interventions

Clinical Pilates Group

Participants will be introduced to the principles of Pilates, the workout program, and its five key elements: neutral spine, lumbopelvic and scapular stabilization, focus, and breathing. Clinical Pilates sessions will be held twice weekly for 8 weeks, 60 minutes each, via synchronous telerehabilitation (Zoom/WhatsApp). Each session includes a 10-minute warm-up, 40 minutes of Pilates exercises, and a 10-minute cool-down. The physiotherapist will provide visual and verbal guidance to ensure correct posture and breathing. Exercises start with 6-8 repetitions in the first week, increasing progressively according to participant ability and advancing to higher-level positions.

Intervention Type: OTHER

Kinesthetic Brain Exercises Group

16 sessions, approximately 40 minutes each, will be administered twice a week for eight weeks by a physical therapist via video chat programs such as Zoom or WhatsApp. Kinesthetic brain exercises consist of three phases: a warm-up phase, an exercise phase, and a cool-down phase. The warm-up and cool-down phases consist of hand-eye coordination and relaxation exercises. The exercise phase consists of independent and dependent movements, as well as a combination of both.

Intervention Type: OTHER

Other Intervention Names

CGP; KBE

Eligibility Criteria

Inclusion Criteria

• • Individuals aged 18-65

• Volunteering
• Female
• Individuals diagnosed with fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria
• Possessing the necessary infrastructure (internet) and equipment (smartphone, tablet, or computer) for telerehabilitation

Exclusion Criteria

• • Having a severe reading comprehension problem

• Having a severe vision or hearing problem
• Being pregnant
• Having an active infection
• Having a neurological or orthopedic problem that prevents mobility
• Having any rheumatic disease other than fibromyalgia
• Having cancer
• Having undergone major surgery within the last 6 months
• Individuals with psychiatric or cognitive disorders that would prevent measurements from being taken in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Izmir Democracy University

OTHER

Sponsor Role: lead

Responsible Party

Betül Taşpınar

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onur Engin, Assist.Prof

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Ferruh Taspinar, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Central Contacts

Betül Taspinar, Prof.Dr.

Role: CONTACT

betul.taspinar@idu.edu.tr

05066804426

Beyzanur Beğenen Şavlı, Msc.Pt.

Role: CONTACT

beyzanurbegenen@gmail.com

+905396812042

Other Identifiers

Fibromyalgia

Identifier Type: -

Identifier Source: org_study_id