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临床试验/CTRI/2025/12/099705
CTRI/2025/12/099705尚未招募2/3 期

MYOGENESIS STIMULATOR- Investigating The Difference In Molecular Mechanisms Of Improvement Following Regular Exercise Programme And Blood Flow Restriction Exercise For Patients With Neuromotor Injuries.

Saveetha medical college hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1

研究概览

简要总结

This study is a single-centre, parallel-group randomized controlled trial designed to compare the effects of conventional exercise rehabilitation and blood flow restriction–assisted myogenesis stimulation on muscle regeneration in patients with neuromotor injuries. Neuromotor disorders are commonly associated with muscle weakness and loss of skeletal muscle mass, leading to functional impairment and reduced quality of life. Emerging rehabilitation strategies such as blood flow restriction training may enhance muscle adaptation through molecular mechanisms even at low exercise intensities.Eligible participants will be randomly allocated into two groups: one group will receive standard exercise rehabilitation, while the other will undergo blood flow restriction–assisted exercise using a myogenesis stimulator. Interventions will be administered for 10–20 minutes per session, 2–3 times per week, over a period of 1–3 weeks. Safety monitoring including vital signs and limb perfusion will be carried out throughout the intervention.The primary outcome measure is the change in molecular markers of muscle regeneration, specifically miR-27b and myogenic regulatory factor-4 (MRF-4), assessed before and after the intervention. Secondary outcomes include changes in skeletal muscle mass measured by DEXA scan, limb circumference, muscle tone, and muscle power. The study aims to generate preliminary evidence on the molecular and functional effects of blood flow restriction–assisted exercise compared with conventional rehabilitation in patients with neuromotor injuries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with neuromotor injuries, Presence of muscle weakness or reduced muscle mass, Age-appropriate patients eligible for exercise rehabilitation, Willingness to participate and provide written informed consent (parental consent where applicable).

排除标准

  • Unstable medical conditions contraindicating exercise therapy, Severe cardiovascular or peripheral vascular disease Local limb infection, open wounds, or contraindications to BFR, Patients unwilling or unable to comply with study procedures.

研究者

发起方
Saveetha medical college hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Logaseni

Saveetha medical college hospital

研究点 (1)

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