NCT04792307

Neuromuscular Electrical Stimulation Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sarcopenia

Interventions

Type	Name	Description
OTHER	Neuromuscular electrical stimulation , no high protein ice cream supplementation	A trained operator applies Neuromuscular electrical stimulation treatment to one leg, for approximately 30 minutes per session, three sessions per week with or without high protein ice cream. Treatment can stimulate the nerve controlling the vastus lateralis muscle in the thigh or the nerve controlling the tibialis anterior muscle in the lower leg, or both. In our study, we will aim to stimulate both nerves and muscle groups, on the basis that the maximal effect with result from the maximal amount of muscle stimulated.Treatment is adjusted to generate a specific force and maintained for up to 5 minutes, followed by a rest period and then repeated three times over the typical 30-minute session. The stimulation can vary according to the frequency (pulses per second, typically 10-50Hz). Additional protein supplementation: high protein ice cream :a single doses of a high protein supplement after each bout of neuromuscular electrical stimulation,

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-03-30
• Completion: 2022-06-30
• First posted: 2021-03-10
• Last updated: 2021-03-10