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

ConditionFibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorIzmir Democracy University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Individuals aged 18-65

Volunteering

Female

Individuals diagnosed with fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria

Disqualifiers

• Having a severe reading comprehension problem

Having a severe vision or hearing problem

Being pregnant

Having an active infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clinical Pilates Group

    Other intervention

    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

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: İntervention groupOther 2 interventions
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Montreal Cognitive Assessment Scale

This is a sensitive assessment scale used to assess cognitive functions. It assesses visual-spatial perception, executive functions, naming, memory, attention, language, abstract thinking, delayed recall, and orientation functions (Selekler et al., 2010). The scale consists of 11 items, and the maximum score is 30. A score of 21 or less indicates cognitive dysfunction.

Time frame
At baseline and after 8 weeks
2

Stroop Test

The Stroop Test reflects frontal region activity and is considered the gold standard for measuring attention. A study by Karakaş et al. determined its reliability and validity in Turkish culture. The Stroop test consists of four sheets of paper measuring 14.0 cm x 21.5 cm. Each sheet contains a total of 24 randomly written words in 6 rows and 4 columns. The test consists of five parts, and each part is scored separately. The first sheet requires reading words written in black; the second sheet requires reading words written in color; the third sheet requires saying the colors of circular shapes; the fourth sheet requires saying only the color of unrelated words written in color without reading them; and the fifth sheet requires correctly saying the color of words printed in a color different from the original. Scoring is based on time, the number of errors, and corrected errors

Time frame
At baseline and after 8 weeks
3

Trail Making Test

The Trail Making Test (TMT) is a two-part test used to assess executive functions, measuring visual-motor skills, processing speed, attention, planning, and set-shifting abilities. In Part A, participants are asked to connect sequential numbers from 1 to 25 in circles, while Part B asks participants to match numbers and letters sequentially (1-A-2-B). Part A assesses processing speed, while Part B assesses set-shifting and sequential thinking skills. Completion times for both sections are recorded

Time frame
at baseline and after 8 weeks.
4

Forward-backward digit span test

It is a short and easy-to-administer test that assesses short-term memory and attention. It consists of two parts: a forward digit span test and a backward digit span test. The forward counting test begins with two 3-digit items and ends with two 9-digit items. The backward counting test begins with two 2-digit items and ends with two 8-digit items. Two attempts are allowed. The maximum score for forward digit span is 8, and for backward digit span, it is 7, for a total of 15 points. Generally, the difference between the forward and backward digit span results is expected to be two

Time frame
at baseline and after 8 weeks.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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