Comparative Effects of Concurrent Training and Soleus Push-Ups on Neurogenesis-Related Biomarkers in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- BDNF (Brain-Derived Neurotrophic Factor)
研究概览
简要总结
This study will examine how two types of exercise programs affect nerve health in people with diabetic peripheral neuropathy. Diabetic peripheral neuropathy is a common complication of type 2 diabetes that can cause numbness, pain, balance problems, and reduced quality of life. Exercise is often recommended for people with diabetes, but it is not yet clear which types of exercise are most effective for improving nerve function.
In this randomized controlled trial, participants with type 2 diabetes and confirmed peripheral neuropathy will be assigned to one of three groups. One group will perform a combined program of aerobic and resistance exercises (concurrent training). Another group will perform soleus push-up exercises, a seated ankle movement designed to activate the soleus muscle and improve glucose metabolism. The third group will continue with standard diabetes care and general lifestyle advice without a structured exercise program.
The study will evaluate whether these exercise interventions influence biological markers related to nerve repair and neuroplasticity, including brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), and the Schwann cell marker S100B. In addition, the study will assess changes in neuropathy symptoms, balance and postural stability, blood sugar control, and quality of life.
Participants will complete assessments before the intervention and again during follow-up after the exercise program. The findings of this study may help identify effective and feasible exercise strategies to support nerve health, improve physical function, and reduce the impact of diabetic peripheral neuropathy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-65 years
- •Diagnosed Type 2 Diabetes Mellitus (T2DM) Confirmed diagnosis of T2DM for at least 5 years.
- •Confirmed Diabetic Peripheral Neuropathy (DPN)
- •Diagnosis is based on clinical evaluation and scoring tools such as:
- •Michigan Neuropathy Screening Instrument (MNSI) Cut-off value of ≥4 for Part A (History)(104) Cut-off value of ≥2 from Part B (Examination)(105)
- •Vibration Pressure Threshold (≥25 Volts)(106)
- •HbA1c between 6.5% and 9.0% Reflecting moderate glycemic control, patients with extremely poor control were excluded for safety.
- •Stable medication regimen No changes in antidiabetic, antihypertensive, or neuropathy medications in the past 3 months.
- •Sedentary or low physical activity level Based on standard questionnaires (International Physical Activity Questionnaire - IPAQ), not currently engaged in structured exercise programs.
- •Ability to walk independently To ensure safety during aerobic or resistance exercise (for Group A).
- •Able to understand and follow instructions
- •Consent to participate and comply with study protocol
- •Written informed consent, obtained before randomization
排除标准
- •History of recent cardiovascular events Includes myocardial infarction, stroke, or any cardiac intervention within the past 6 months.
- •Uncontrolled hypertension Blood pressure ≥160/100 mmHg at rest.
- •Severe musculoskeletal disorders or physical disability Including joint deformities, fractures, or amputation that limit the ability to perform exercise.
- •Severe diabetic foot ulcers or active lower limb infection Increases risk during lower limb activity or exercise.
- •End-stage renal disease (CKD stage 4 or higher) Associated systemic complications may confound study outcomes or affect safety.
- •Severe retinopathy or proliferative diabetic eye disease Exercise may pose risks such as retinal hemorrhage.
- •Current Smoker, tobacco or alcohol consumer. That may affect the blood biomarkers.
- •Cognitive impairment or psychiatric disorders That may affect understanding, compliance, or safety during exercise.
- •Participation in a structured exercise program within the last 3 months To avoid training-induced bias and ensure a sedentary baseline.
- •Chronic inflammatory or autoimmune conditions Conditions like rheumatoid arthritis or lupus may alter neurotrophic biomarkers.
- •Use of medications affecting neurogenesis or metabolism Such as corticosteroids, antipsychotics, or immunosuppressants.
- •Diagnosed sleep disorder
- •That may affect the outcomes of the intervention.
- •Pregnancy or lactation Due to altered physiology and ethical concerns.
结局指标
主要结局
BDNF (Brain-Derived Neurotrophic Factor)
时间窗: From enrollment to 4 weeks and then to the end of treatment at 8 weeks.
Serum Brain-Derived Neurotrophic Factor (BDNF) concentration will be measured quantitatively using a commercially available enzyme-linked immunosorbent assay (ELISA) kit at baseline, 4 weeks, and 8 weeks. BDNF is a neurotrophic factor involved in neuronal survival, synaptic plasticity, and exercise-induced neuroplasticity. Changes in circulating BDNF levels will be used as a primary biomarker of exercise-induced neuroplasticity and neurogenesis-related biological activity. Higher serum BDNF concentrations are considered indicative of greater neurotrophic activity and potential enhancement of neuroplastic processes.
NGF (Nerve Growth Factor)
时间窗: From enrollement to 4 weeks and then after 8 weeks of intervention
Serum Nerve Growth Factor (NGF) concentration will be measured quantitatively using a commercially available enzyme-linked immunosorbent assay (ELISA) kit at baseline, 4 weeks, and 8 weeks. NGF is a key neurotrophic factor involved in the survival, maintenance, and regeneration of peripheral neurons. It plays a fundamental role in peripheral nerve repair and axonal regeneration following nerve injury. Changes in circulating NGF levels will be used as a primary biomarker of peripheral nerve regeneration and neuroregeneration-related biological activity. Higher serum NGF concentrations are considered indicative of enhanced neurotrophic support and regenerative potential of peripheral nerves.
S100B (Schwann Cell Marker)
时间窗: From enrollment to 4 weeks and then after 8 weeks of intervention
Serum S100 Calcium-Binding Protein B (S100B) concentration will be measured quantitatively using a commercially available enzyme-linked immunosorbent assay (ELISA) kit at baseline, 4 weeks, and 8 weeks. S100B is a calcium-binding protein that is expressed by Schwann cells in the peripheral nervous system and plays an important role in peripheral nerve repair, remyelination, and axonal regeneration. Changes in circulating S100B levels will be used as a primary biomarker of Schwann cell activity and peripheral nerve regeneration. Higher serum S100B concentrations are considered indicative of increased Schwann cell-mediated neuroregenerative activity.
次要结局
- Michigan Neuropathy Screening Instrument (MNSI)(From enrollment to 4 weeks and then to the end of treatment at 8 weeks.)
- Vibration perception threshold (VPT)(From enrollment to 4 weeks and then to the end of treatment at 8 weeks.)
- Balance and Gait Mobile Application(From enrollment to 4 weeks and then to the end of treatment at 8 weeks.)
- Glycated Hemoglobin (HbA1c)(From enrollment to 4 weeks and then to the end of treatment at 8 weeks.)
- Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN)(From enrollment to 4 weeks and then to the end of treatment at 8 weeks.)
- Acceptability of Intervention Measure (AIM)(At the end of treatment at 8 weeks.)
- Intervention Appropriateness Measure (IAM)(At the end of treatment after 8 weeks of intervention)
- Feasibility of Intervention Measure (FIM)(At the end of treatment after 8 weeks of intervention.)