Neuromuscular Electrical Stimulation Study — IMMI  

Sarcopenia Clinical Trial

Official title: Feasibility RCT of Neuromuscular Electrical Stimulation; an Intervention to Maintain and Improve neuroMuscular Function During Periods of Immobility

Status Not yet recruiting

Clinical Trial Summary

In this study, the investigators will use feasibility RCT design to determine whether it is justifiable to conduct a large-scale clinical trial of neuromuscular electrical stimulation with or without additional protein supplementation in hospitalised patients who are temporarily immobilised following a fragility fracture. Muscle thickness, muscle strength, patients' mobility and self-care will be assessed at baseline and after 6-wk trial duration or until patients discharged from hospital. Outcomes will include participants' recruitment rate, tolerability and accessibility and their characteristics.

Clinical Trial Description

In frail elderly people with existing sarcopenia, muscle mass, muscle strength and muscle function during immobility after lower limb fractures are impaired and affect their functional abilities to achieve activities of daily living. To reverse these consequences, limited intervention studies show that resistance exercise training and protein supplement at least partly reverses sarcopenia. However, guidelines do not currently advise specific protein supplementation as a treatment to prevent or reverse sarcopenia. Additionally, these exercises are difficult to perform in adequate intensity when patients are ill, tired, or in pain and these same factors may reduce appetite. In this study, the investigators aim to evaluate the effect of neuromuscular electrical stimulation with and without a high protein oral nutritional supplement.

Methods:

In this study, the investigators will use feasibility RCT design to determine whether it is justifiable to conduct a large-scale clinical trial of neuromuscular electrical stimulation with or without additional protein supplementation in hospitalised patients who are temporarily immobilised following a fragility fracture. Muscle thickness, muscle strength, patients' mobility and self-care will be assessed at baseline and after 6-wk trial duration or until patients discharged from hospital. Outcomes will include participants' recruitment rate, tolerability and accessibility and their characteristics.

Discussion This study addresses the effects of neuromuscular electrical stimulation with or without high protein supplements on mobility, self-care, muscle mass and strength in immobile older people with frailty after lower limb fracture. The information from this study may justify a large-scale clinical trial of using electrical stimulation with or without high protein supplement. ;

Related Conditions & MeSH terms

• Sarcopenia

• NCT number: NCT04792307
• Study type: Interventional
• Source: Nottingham University Hospitals NHS Trust
• Contact: John Gladman, Prof.
• Phone: 0441158230242
• Email: John.Gladman@nottingham.ac.uk
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Completion date: June 30, 2022