Concurrent Training vs Soleus Push-Ups on Neurogenesis-Related Biomarkers in Diabetic Neuropathy Patients

Официальное название

Comparative Effects of Concurrent Training and Soleus Push-Ups on Neurogenesis-Related Biomarkers in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое Concurrent Training
  Combined aerobic and resistance exercise program.
• Другое Soleus Push-ups
  Seated plantar-flexion exercises targeting the soleus muscle, using a controlled movement protocol

Первичные конечные точки

• BDNF (Brain-Derived Neurotrophic Factor) [Срок оценки: From enrollment to 4 weeks and then to the end of treatment at 8 weeks.]
• NGF (Nerve Growth Factor) [Срок оценки: From enrollement to 4 weeks and then after 8 weeks of intervention]
• S100B (Schwann Cell Marker) [Срок оценки: From enrollment to 4 weeks and then after 8 weeks of intervention]

Вторичные конечные точки (8)

• Michigan Neuropathy Screening Instrument (MNSI) [Срок оценки: From enrollment to 4 weeks and then to the end of treatment at 8 weeks.]
• Vibration perception threshold (VPT) [Срок оценки: From enrollment to 4 weeks and then to the end of treatment at 8 weeks.]
• Balance and Gait Mobile Application [Срок оценки: From enrollment to 4 weeks and then to the end of treatment at 8 weeks.]
• Glycated Hemoglobin (HbA1c) [Срок оценки: From enrollment to 4 weeks and then to the end of treatment at 8 weeks.]
• Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) [Срок оценки: From enrollment to 4 weeks and then to the end of treatment at 8 weeks.]
• Acceptability of Intervention Measure (AIM) [Срок оценки: At the end of treatment at 8 weeks.]
• Intervention Appropriateness Measure (IAM) [Срок оценки: At the end of treatment after 8 weeks of intervention]
• Feasibility of Intervention Measure (FIM) [Срок оценки: At the end of treatment after 8 weeks of intervention.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Pakistan Railways General Hospital and Mediplex Healthcare Center — Rawalpindi

Публикации

• Jamali A, Shahrbanian S, Morteza Tayebi S. The Effects of Exercise Training on the Brain-Derived Neurotrophic Factor (BDNF) in the Patients with Type 2 Diabetes: A Systematic Review of the Randomized Controlled Trials. J Diabetes Metab Disord. 2020 May 6;19(1):633-643. doi: 10.1007/s40200-020-00529-w. eCollection 2020 Jun. PMID 32550216

Идентификаторы

NCT: NCT07675720 · RCRAHS-ISB/REC/PhD/011112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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