Type 2 DiabetesNCT07414914
Self-Myofascial Release Plus Exercise Versus Exercise Alone in Type 2 Diabetes
A study testing Exercise Program and Self-Myofascial Release in people with Type 2 Diabetes, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exercise Program and Self-Myofascial Release
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2025to 4 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakırçay University Çiğli Regional Education Hospital
Izmir, İzmir, TR-35620
Elif Umay ALTAŞ, MD, +905053076622, elifumayaslan@hotmail.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Exercise Program, Self-Myofascial Release
- Keywords
- Exercise therapy, Self-myofascial release, Physical performance, Foot function, Plantar fascia
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
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 ReleaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group :8-week supervised exercise program, 3 times per week. | Active comparator | 8-week supervised strengthening and stretching program performed three times weekly Receives: Behavioral: Exercise Program |
| Exercise Plus Self-Myofascial Release Group | Experimental | 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. Receives: Behavioral: Exercise Program; Other: Self-Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function Index (FFI)
The Foot Function Index will be used to assess pain and disability related to foot function.
Measured: Baseline and 8 weeks
Secondary outcomes (6)
Single-Leg Stance Test (Eyes Open and Eyes Closed)
Static balance will be assessed using the single-leg stance test under eyes-open and eyes-closed conditions.
Measured: Baseline and 8 weeks
Timed Up and Go Test (TUG)
Functional mobility will be evaluated using the Timed Up and Go test.
Measured: Baseline and 8 weeks
Unilateral Heel-Rise Test
Calf muscle endurance will be assessed using the unilateral heel-rise test.
Measured: Baseline and 8 weeks
Berg Balance Scale (BBS)
Balance performance will be assessed using the Berg Balance Scale.
Measured: Baseline and 8 weeks
10-Meter Walk Test (Single-Task and Dual-Task)
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).
Measured: Baseline and 8 weeks
Plantar Fascia Thickness
Plantar fascia thickness will be measured using ultrasonography.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start3 Nov 2025
- Primary completion4 May 2026 (estimated)
- Study completion4 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Cigli Regional Training Hospital
- Responsible party
- Principal investigator, Sümena Hareket, Izmir Katip Celebi University
- Investigators
- Sevtap GUNAY UÇURUM, Prof, Study director, Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414914
- Sponsor's protocol ID
- 1845
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 34776128Ranbhor 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.
PubMed 34054254Kiyono 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.
PubMed 33044364Cakici 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.
PubMed 36990015Konrad 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.
PubMed 35616852
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07414914
- Acronym / sponsor ID
- 1845
- Conditions
- Type 2 Diabetes
- Keywords
- Exercise therapy, Self-myofascial release, Physical performance, Foot function, Plantar fascia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Cigli Regional Training Hospital
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 4 May 2026 (estimated)
- Study completion
- 4 May 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Exercise Group :8-week supervised exercise program, 3 times per week. | Active comparator | Behavioral: Exercise Program8-week supervised strengthening and stretching program performed three times weekly |
| Exercise Plus Self-Myofascial Release Group | Experimental | Behavioral: Exercise Program, Other: Self-Myofascial ReleaseAn 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramAn 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. | Behavioural | Exercise Group :8-week supervised exercise program, 3 times per week., Exercise Plus Self-Myofascial Release Group |
| Self-Myofascial ReleaseSelf-myofascial release applied to the plantar fascia and gastrosoleus muscles using a foam roller three times per week for eight weeks before exercise sessions. | Other | Exercise Plus Self-Myofascial Release Group |
Primary outcome
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.
6 secondary outcomes
Single-Leg Stance Test (Eyes Open and Eyes Closed)
Time frame: Baseline and 8 weeks
Timed Up and Go Test (TUG)
Time frame: Baseline and 8 weeks
Unilateral Heel-Rise Test
Time frame: Baseline and 8 weeks
Berg Balance Scale (BBS)
Time frame: Baseline and 8 weeks
10-Meter Walk Test (Single-Task and Dual-Task)
Time frame: Baseline and 8 weeks
Plantar Fascia Thickness
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Results publication: PubMed 34776128Freire 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.
- Results publication: PubMed 34054254Ranbhor 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.
- Results publication: PubMed 33044364Kiyono 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.
- Results publication: PubMed 36990015Cakici 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.
- Results publication: PubMed 35616852Konrad 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevtap GUNAY UÇURUM, Prof study director
Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program and Self-Myofascial Release in people with Type 2 Diabetes, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümena HAREKET KARAKAYA, PT (+905397264665, SumenaHareket4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Function Index (FFI) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07414914, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.