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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Foot Function Index (FFI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exercise Group :8-week supervised exercise program, 3 times per week.
8-week supervised strengthening and stretching program performed three times weekly
干预措施: Exercise Program (Behavioral)
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.
干预措施: Exercise Program (Behavioral)
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.
干预措施: Self-Myofascial Release (Other)
结局指标
主要结局
Foot Function Index (FFI)
时间窗: Baseline and 8 weeks
The Foot Function Index will be used to assess pain and disability related to foot function.
次要结局
- Berg Balance Scale (BBS)(Baseline and 8 weeks)
- Single-Leg Stance Test (Eyes Open and Eyes Closed)(Baseline and 8 weeks)
- Timed Up and Go Test (TUG)(Baseline and 8 weeks)
- Unilateral Heel-Rise Test(Baseline and 8 weeks)
- 10-Meter Walk Test (Single-Task and Dual-Task)(Baseline and 8 weeks)
- Plantar Fascia Thickness(Baseline and 8 weeks)
研究者
Sümena Hareket
Physiotherapist, MSc student
Izmir Katip Celebi University