Health TrialsbyHealthPanel

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

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorIzmir Katip Celebi University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Exercise Group :8-week supervised exercise program, 3 times per week.Active comparator 1 intervention
Group B: Exercise Plus Self-Myofascial Release GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Foot Function Index (FFI)

The Foot Function Index will be used to assess pain and disability related to foot function.

Time frame
Baseline and 8 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 8 weeks
2

Timed Up and Go Test (TUG)

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

Time frame
Baseline and 8 weeks
3

Unilateral Heel-Rise Test

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

Time frame
Baseline and 8 weeks
4

Berg Balance Scale (BBS)

Balance performance will be assessed using the Berg Balance Scale.

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Izmir Katip Celebi University

Lead sponsor

Cigli Regional Training Hospital

Collaborator

Source ClinicalTrials.gov
Apply now