Impact of NMES and HPRO on Recovery After SAH- Pilot Study

Not Applicable

Recruiting

• Conditions: Subarachnoid Hemorrhage; Inflammation; Nutritional and Metabolic Disease; Muscle Atrophy
• Interventions: Device: Neuromuscular Electrical Stimulation (NMES); Dietary Supplement: High Protein Supplementation

• Registration Number: NCT03201094
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

The study purpose is to investigate the hypothesis that in adults with SAH, early neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls receiving standard of care interventions for nutrition and mobilization. The investigators will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH. This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as compared to age and severity-matched SAH patients undergoing standard of care interventions for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and NMES interventions have upon inflammatory cytokines and markers of energy balance. Results of this study will establish evidence for precision nutrition plus early exercise to mitigate the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health recovery outcomes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2017-12-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-05-31
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPRO + NMES	High Protein Supplementation	Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.
HPRO only	High Protein Supplementation	Patients will receive HPRO three times daily during study period
HPRO + NMES	Neuromuscular Electrical Stimulation (NMES)	Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.
NMES only	Neuromuscular Electrical Stimulation (NMES)	Patients will undergo two 30 minute NMES sessions per day during study period.

Primary Outcome Measures

Name	Time	Method
Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.	14 days	Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound.

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States