Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07414914

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bakırçay University Çiğli Regional Education Hospital

Izmir, İzmir, TR-35620, Turkey (Türkiye)

Location status: Recruiting

Location contact

Elif Umay ALTAŞ, MD

CONTACT

[email protected]

+905053076622

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Program

Behavioral

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

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Timed Up and Go Test (TUG)

    Time frame: Baseline and 8 weeks

    Functional mobility will be evaluated using the Timed Up and Go test.

  3. Unilateral Heel-Rise Test

    Time frame: Baseline and 8 weeks

    Calf muscle endurance will be assessed using the unilateral heel-rise test.

  4. Berg Balance Scale (BBS)

    Time frame: Baseline and 8 weeks

    Balance performance will be assessed using the Berg Balance Scale.

  5. 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).

  6. Plantar Fascia Thickness

    Time frame: Baseline and 8 weeks

    Plantar fascia thickness will be measured using ultrasonography.

Study contacts

Contact information is provided by the study sponsor or research team.

Müge KIRMIZI, PhD

CONTACT

[email protected]

+905056013348

Sümena HAREKET KARAKAYA, PT

CONTACT

[email protected]

+905397264665

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Collaborators

  • Cigli Regional Training Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.