Self-Myofascial Release Plus Exercise Versus Exercise Alone in Type 2 Diabetes
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
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Nov 2025
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2025
CompletedFirst Submitted
Initial submission to the registry
February 11, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2026
CompletedFebruary 17, 2026
February 1, 2026
6 months
February 11, 2026
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Foot Function Index (FFI)
The Foot Function Index will be used to assess pain and disability related to foot function.
Baseline and 8 weeks
Secondary Outcomes (6)
Single-Leg Stance Test (Eyes Open and Eyes Closed)
Baseline and 8 weeks
Timed Up and Go Test (TUG)
Baseline and 8 weeks
Unilateral Heel-Rise Test
Baseline and 8 weeks
Berg Balance Scale (BBS)
Baseline and 8 weeks
10-Meter Walk Test (Single-Task and Dual-Task)
Baseline and 8 weeks
- +1 more secondary outcomes
Study Arms (2)
Exercise Group :8-week supervised exercise program, 3 times per week.
ACTIVE COMPARATOR8-week supervised strengthening and stretching program performed three times weekly
Exercise Plus Self-Myofascial Release Group
EXPERIMENTALAn 8-week supervised strengthening and stretching exercise program performed three times per week combined with self-myofascial release applied to the plantar fascia and gastrosoleus muscles using a foam roller before exercise sessions.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Izmir Katip Celebi Universitylead
- Cigli Regional Training Hospitalcollaborator
Study Sites (1)
Bakırçay University Çiğli Regional Education Hospital
Izmir, İzmir, TR-35620, Turkey (Türkiye)
Related Publications (5)
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: 34776128RESULTRanbhor 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: 34054254RESULTKiyono 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: 33044364RESULTCakici 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: 36990015RESULTKonrad 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: 35616852RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sevtap GUNAY UÇURUM, Prof
Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Central Study Contacts
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
- Physiotherapist, MSc student
Study Record Dates
First Submitted
February 11, 2026
First Posted
February 17, 2026
Study Start
November 3, 2025
Primary Completion
May 4, 2026
Study Completion
May 4, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02