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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT03201094
Status
Recruiting
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Conditions

  • Inflammation
  • Muscle Atrophy
  • Nutritional and Metabolic Disease
  • Subarachnoid Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neuromuscular Electrical Stimulation (NMES) — DEVICE
    Neuromuscular electrical stimulation twice daily during study period.
  • High Protein Supplementation — DIETARY_SUPPLEMENT
    High protein supplementation with whey protein shakes taken three times a day during study period.

Study Details

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.

Key Dates

Start date
Dec 1, 2017
Status verified
May 2026
Primary completion
May 31, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care
    Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.
  • Experimental: HPRO + NMES
    Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.
  • Experimental: NMES only
    Patients will undergo two 30 minute NMES sessions per day during study period.
  • Experimental: HPRO only
    Patients will receive HPRO three times daily during study period

Primary Outcome Measure

Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period. [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201
Neeraj Badjatia, MD MS
[email protected]
4103284515

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By research site
University of Maryland Medical Center· Baltimore, MD

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