Self-Myofascial Release Plus Exercise Versus Exercise Alone in Type 2 Diabetes

Официальное название

The Effect of the Addition of Myofascial Release to Exercise Program on Foot Function, Physical Performance, and Plantar Fascia Thickness in Individuals With Type 2 Diabetes: A Randomized Controlled Trial

Обзор

This randomized controlled trial aims to investigate the effects of adding self-myofascial release applied to the plantar fascia and gastrosoleus muscles to an exercise program on foot function, physical performance, and plantar fascia thickness in individuals with type 2 diabetes. Participants aged 30 to 65 years with controlled type 2 diabetes will be randomly allocated to either an exercise-only group or an exercise plus self-myofascial release group. Both groups will complete an eight-week supervised exercise program three times per week. The intervention group will additionally perform self-myofascial release using a foam roller before exercise sessions. Outcomes will include foot function, balance, functional mobility, gait performance, and plantar fascia thickness assessed by ultrasonography before and after the intervention.

Подробное описание

This randomized controlled trial will investigate the effects of adding self-myofascial release applied to the plantar fascia and gastrosoleus muscles to exercise therapy on foot function, physical performance, and plantar fascia thickness in individuals with type 2 diabetes. Individuals aged 30 to 65 years with controlled type 2 diabetes diagnosed for at least one year and able to ambulate independently without assistive devices will be included.

Participants will be randomly allocated into two groups. The exercise group will receive an eight-week exercise program, while the exercise plus self-myofascial release group will receive the same exercise program combined with self-myofascial release applied to the plantar fascia and gastrosoleus muscles.

The eight-week exercise program will include supervised general strengthening exercises targeting the upper and lower extremities, back, and core muscles, as well as stretching exercises for warm up and cool down, performed three times per week. In addition, participants will be advised to perform at least 150 minutes per week of moderate-intensity walking. Adherence will be supported with an informational brochure and monitored using an exercise diary.

Self-myofascial release will be applied using a foam roller three times per week for eight weeks before the exercise sessions.

Outcome measures will include the Foot Function Index, single-leg stance test with eyes open and closed, Timed Up and Go test, unilateral heel-rise test, Berg Balance Scale, and 10-meter walk test performed under single-task and dual-task conditions, including a cognitive task (verbal fluency using words starting with the letter "k") and a motor task (continuous head rotations paced at 40 beats per minute using a metronome). Plantar fascia thickness will be assessed by ultrasonography. All assessments will be conducted before and after the eight-week intervention.

Вмешательства

• Поведенческое Exercise Program
  An 8-week supervised strengthening and stretching program performed three times weekly, with advice to perform at least 150 minutes per week of moderate-intensity walking.
• Другое Self-Myofascial Release
  Self-myofascial release applied to the plantar fascia and gastrosoleus muscles using a foam roller three times per week for eight weeks before exercise sessions.

Первичные конечные точки

• Foot Function Index (FFI) [Срок оценки: Baseline and 8 weeks]

Вторичные конечные точки (6)

• Single-Leg Stance Test (Eyes Open and Eyes Closed) [Срок оценки: Baseline and 8 weeks]
• Timed Up and Go Test (TUG) [Срок оценки: Baseline and 8 weeks]
• Unilateral Heel-Rise Test [Срок оценки: Baseline and 8 weeks]
• Berg Balance Scale (BBS) [Срок оценки: Baseline and 8 weeks]
• 10-Meter Walk Test (Single-Task and Dual-Task) [Срок оценки: Baseline and 8 weeks]
• Plantar Fascia Thickness [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

• Individuals aged 30 to 65 years
• Diagnosed with type 2 diabetes mellitus for at least 1 year
• Controlled type 2 diabetes mellitus
• Able to ambulate independently without assistive devices

Критерии исключения

• Severe pes planus or pes cavus defined by the Foot Posture Index-6 (FPI-6) (score ≥ +10 or ≤ -5)
• History of plantar fasciitis
• Plantar fascia ulceration
• Peripheral neuropathy
• Diagnosed peripheral vascular disease
• History of lower extremity surgery or fracture during last year
• Rheumatologic or connective tissue disorders affecting soft tissue properties
• Neurological or diagnosed cognitive disorders
• Pregnancy
• Other types of diabetes mellitus
• Obesity (BMI > 30 kg/m²)
• Serious cardiopulmonary disorders, including heart failure, history of myocardial infarction, or severe chronic obstructive pulmonary disease or asthma

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Bakırçay University Çiğli Regional Education Hospital — Izmir

Публикации

• Freire Ribeiro DL, Medeiros FVA, Marinho EBA, Ferreira Junior JB, Bottaro MF, Carmo JC. Effects of myofascial release of the ankle plantar flexors on static postural balance of young men: A randomized clinical trial. J Bodyw Mov Ther. 2021 Oct;28:121-125. doi: 10.1016/j.jbmt.2021.07.034. Epub 2021 Aug 19. PMID 34776128
• Ranbhor AR, Prabhakar AJ, Eapen C. Immediate effect of foam roller on pain and ankle range of motion in patients with plantar fasciitis: A randomized controlled trial. Hong Kong Physiother J. 2021 Jun;41(1):25-33. doi: 10.1142/S1013702521500025. Epub 2020 Oct 8. PMID 34054254
• Kiyono R, Onuma R, Yasaka K, Sato S, Yahata K, Nakamura M. Effects of 5-Week Foam Rolling Intervention on Range of Motion and Muscle Stiffness. J Strength Cond Res. 2022 Jul 1;36(7):1890-1895. doi: 10.1519/JSC.0000000000003757. Epub 2020 Oct 9. PMID 33044364
• Cakici R, Saldiran TC, Kara I, Acik H. Plantar fascia stiffness in patients with type 2 diabetes mellitus: Stiffness effect on fall risk and gait speed. Foot (Edinb). 2023 Sep;56:102020. doi: 10.1016/j.foot.2023.102020. Epub 2023 Mar 17. PMID 36990015
• Konrad A, Nakamura M, Tilp M, Donti O, Behm DG. Foam Rolling Training Effects on Range of Motion: A Systematic Review and Meta-Analysis. Sports Med. 2022 Oct;52(10):2523-2535. doi: 10.1007/s40279-022-01699-8. Epub 2022 May 26. PMID 35616852

Идентификаторы

NCT: NCT07414914 · 1845

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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