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

February 11, 2026 updated by: Sümena Hareket, Izmir Katip Celebi University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • İzmir
      • Izmir, İzmir, Turkey (Türkiye), TR-35620
        • Recruiting
        • Bakırçay University Çiğli Regional Education Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise Group :8-week supervised exercise program, 3 times per week.
8-week supervised strengthening and stretching program performed three times weekly
Behavioral: 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.
Experimental: Exercise Plus Self-Myofascial Release Group
An 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.
Behavioral: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Function Index (FFI)
Time Frame: Baseline and 8 weeks
The Foot Function Index will be used to assess pain and disability related to foot function.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single-Leg Stance Test (Eyes Open and Eyes Closed)
Time Frame: Baseline and 8 weeks
Static balance will be assessed using the single-leg stance test under eyes-open and eyes-closed conditions.
Baseline and 8 weeks
Timed Up and Go Test (TUG)
Time Frame: Baseline and 8 weeks
Functional mobility will be evaluated using the Timed Up and Go test.
Baseline and 8 weeks
Unilateral Heel-Rise Test
Time Frame: Baseline and 8 weeks
Calf muscle endurance will be assessed using the unilateral heel-rise test.
Baseline and 8 weeks
Berg Balance Scale (BBS)
Time Frame: Baseline and 8 weeks
Balance performance will be assessed using the Berg Balance Scale.
Baseline and 8 weeks
10-Meter Walk Test (Single-Task and Dual-Task)
Time Frame: Baseline and 8 weeks
Gait performance will be assessed using the 10-meter walk test 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).
Baseline and 8 weeks
Plantar Fascia Thickness
Time Frame: Baseline and 8 weeks
Plantar fascia thickness will be measured using ultrasonography.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Collaborators

Cigli Regional Training Hospital

Investigators

  • Study Director: Sevtap GUNAY UÇURUM, Prof, Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

May 4, 2026

Study Completion (Estimated)

May 4, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing plans have not yet been determined. De-identified individual participant data may be shared upon reasonable request following publication, subject to institutional and ethical approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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