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

Not Applicable

• Conditions: Duchenne Muscular Dystrophy (DMD)
• Interventions: Procedure: Remote Ischemic Preconditioning Training Apparatus

• Registration Number: NCT02614820
• Lead Sponsor: General Hospital of Chinese Armed Police Forces

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-22
• Last Update Submitted: 2015-11-22
• Study First Posted: 2015-11-25
• Last Update Posted: 2015-11-25
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Remote Ischemic Preconditioning Training Apparatus	inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals
control group	Remote Ischemic Preconditioning Training Apparatus	inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals

Primary Outcome Measures

Name	Time	Method
Serum CK value	6 months
Serum myoglobin values	3 days

Secondary Outcome Measures

Name	Time	Method
Serum myoglobin values	3 months

Trial Locations

Locations (1)

Shiwen wu; 🇨🇳 BeiJing, China