Impact of NMES and HPRO on Recovery After SAH- Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
. Being diagnosed with aneurysmal SAH
. Aneurysmal repair within 48 hours of ictus.
. Age between 25 and 80 years old. (>=25 years old and <=80 years old)
. Expected stay in the NCCU > 72 hours.
Disqualifiers
. Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;
. Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;
. Unlikely to remain in the ICU for more than 7 days;
. Body mass index < 15 or >40 kg/m2;
Trial design
Design model
Parallel
Treatments tested in this trial
Neuromuscular Electrical Stimulation (NMES)
DeviceNeuromuscular electrical stimulation twice daily during study period.
High Protein Supplementation
Dietary supplementHigh protein supplementation with whey protein shakes taken three times a day during study period.
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: HPRO + NMESExperimental treatment 2 interventions
Group C: NMES onlyExperimental treatment 1 intervention
Group D: HPRO onlyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.
Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound.
Time frame
14 daysSponsors and contacts
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Source ClinicalTrials.gov