The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD

General Hospital of Chinese Armed Police Forces

Status: Unknown

Conditions: Duchenne Muscular Dystrophy (DMD)

Treatments: Procedure: Remote Ischemic Preconditioning Training Apparatus

Study type: Interventional

Funder types: Other

Identifiers

NCT02614820

JZheng

Details and patient eligibility

About

Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary disease and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid is the only proven effective medicine,while side effects limit its use. Recent studies have shown that the vascular density in the DMD patients' muscle is decreased,so muscle are in ischemic and anoxic. Remote ischemic preconditioning(RIPC) can improve the capable of resistanting ischemia and hypoxia and maybe a potential therapy for DMD patients.

Methods: 100 patients (aged 2 to 6 years)will be divided into two groups(treatment and control groups) randomly. Treatment group will receive an RIPC stimulus (inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals) while control group will receive a similar stimulus (inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals). Serum kinase level ,Blood levels of myoglobin, Evaluation of motor function(Four steps test;6-minute walking test) and MRI of lower limbs）at 0 days, 3 days, 3months ,6months.

Purpose：

1. To evaluate the safety and tolerability of remote ischemic preconditioning for DMD patients
2. To identify the effectiveness of remote ischemic preconditioning for DMD patients.

Enrollment: 100 estimated patients

Sex: Male

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Genetic analysis of DMD; from 2 to 6 years old ;without other diseases .

Exclusion Criteria: other congenital diseases;upper respiratory infection, gastroenteritis, vaccination, trauma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

treatment group

Experimental group

Description:

inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals

Treatment:

Procedure: Remote Ischemic Preconditioning Training Apparatus

control group

Other group

Description:

inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals

Treatment:

Procedure: Remote Ischemic Preconditioning Training Apparatus