Adding foam-roller self-myofascial release to an exercise program for people with 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
This trial will test whether adding foam-roller self-myofascial release to an eight-week exercise program helps adults aged 30–65 with controlled type 2 diabetes improve foot function, balance, walking, and plantar fascia thickness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | Female |
| Sponsor | Izmir Katip Celebi University Academic / other |
| Locations | 1 site (Izmir, İzmir) |
| Trial ID | NCT07414914 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will compare an eight-week supervised exercise program alone versus the same program plus self-myofascial release applied with a foam roller to the plantar fascia and gastrosoleus muscles. Both groups will attend supervised sessions three times per week and be encouraged to perform at least 150 minutes per week of moderate walking, with adherence tracked by an exercise diary. Outcomes measured before and after the intervention include the Foot Function Index, single-leg stance with eyes open and closed, Timed Up and Go, unilateral heel-rise test, gait performance, and plantar fascia thickness by ultrasonography. Eligible participants are adults 30–65 years with controlled type 2 diabetes who ambulate independently, while people with neuropathy, peripheral vascular disease, obesity (BMI >30), recent lower-limb surgery, plantar fasciitis, or foot ulcers are excluded.
Who should consider this trial
Good fit: Adults aged 30–65 with controlled type 2 diabetes for at least one year who can walk without an assistive device and do not have neuropathy, peripheral vascular disease, significant foot deformity, or BMI over 30 are the best candidates.
Not a fit: People with peripheral neuropathy, peripheral vascular disease, active foot ulcers, prior plantar fasciitis, recent lower-limb surgery or fracture, obesity (BMI >30), or serious cardiopulmonary or neurologic conditions are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adding self-myofascial release could improve foot function, balance, and mobility and reduce plantar fascia thickness, helping people with type 2 diabetes walk more comfortably.
How similar studies have performed: Small trials in athletes and older adults have reported short-term improvements in mobility and tissue stiffness with self-myofascial release, but evidence is limited for people with type 2 diabetes and for changing plantar fascia thickness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Izmir, İzmir
- Bakırçay University Çiğli Regional Education Hospital — Izmir, İzmir, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sümena HAREKET KARAKAYA, PT
- Email: SumenaHareket4@gmail.com
- Phone: +905397264665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.