Neuromuscular Electrical Stimulation Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sarcopenia

Intervention / Treatment
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* Other: Neuromuscular electrical stimulation , no high protein ice cream supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/=65 years Hospitalised due to incident fragility fracture (hip, spine, pelvis, rib, upper limb, lower limb) Immobile 72 hours after admission or completion of surgery whichever is the later. Predicted date of discharge >/= 7 days after recruitment Exclusion Criteria: Unable to give valid informed consent Residence outside catchment area of hospital (likely to be moved during the study period) Unable to communicate in English sufficiently to participate in neuromuscular electrical stimulation. Implanted medical device (e.g. pacemaker) Any other contraindications to neuromuscular electrical stimulation (e.g. injury to the stimulation sites) Leg amputation or any pre-injury conditions affecting a leg unilaterally such as hemiparesis Dysphagia for liquids Protein supplementation clinically indicated and prescribed End stage renal failure Obesity (BMI>30) End of life, for any reason Any other clinical reason why rehabilitation is not clinically indicated Within 10 days of being symptom free having been COVID-19 positive (PCR testing or clinical criteria), or other barrier nursed patients Lactose intolerance

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: will randomly allocate participants offering half of them additional protein supplementation over and above their ordinary diet
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neuromuscular electrical stimulation (NMES) to one leg<br>NMES left leg, no high protein ice cream supplementation NMES right leg, no high protein ice cream supplementation | Other: Neuromuscular electrical stimulation , no high protein ice cream supplementation<br>* 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,<br>* Other names: Neuromuscular electrical stimulation with high protein ice cream supplementation;|
| Other: High protein ice cream supplementation<br>NMES left leg, high protein ice cream supplementation NMES right leg, high protein ice cream supplementation | Other: Neuromuscular electrical stimulation , no high protein ice cream supplementation<br>* 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,<br>* Other names: Neuromuscular electrical stimulation with high protein ice cream supplementation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower limb muscle strength | using A hand-held dynamometer for both vastus lateralis and tibialis anterior muscles | Change from Baseline lower limb muscle strength at 6 weeks | 
| Hand grip strength | using a standard device | Change from Baseline Hand grip strength at 6 weeks | 
| Ultrasound | Ultrasound parameters of vastus lateralis and tibialis anterior muscles (thickness, pennation angle, echogenicity). | Change from Baseline lower limb muscle thickness at 6 weeks | 
| iEMG derived motor unit structure and function | intramuscular electromyography (iEMG) measures of muscle control | Change from Baseline lower limb muscle control at 6 weeks | 
| Elderly Mobility Scale | measuring 9 domains from very fit 1 to terminally ill 9 | Change from Baseline functional independence at 6 weeksand  6 months | 
| Nottingham Extended ADL | The Answers to the questions should be given whenever possible by the person who is the subject of the questionnaire Answers should be recorded by ticking one box for each question | Change from Baseline functional independence at 6 weeksand  6 months | 
| Disability and functional independence using Barthel ADL score. | an ordinal scale used to measure performance in activities of daily living (ADL). variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge. | Change from Baseline functional independence at 6 weeks and  6 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability measurement | high number yes, low number no | up to 6 weeks | 
| Pain/Visual analogue scores | 1 less pain, 10 severe pain | Change from Baseline functional independence at 6 weeks  | 
| Mortality Rate | the number of participants who died within 6 months period after recruitment. | At 6 months after recruitment | 
| Number of protein supplementation doses consumed | How many cups participants consumed 1 cup lowest and 18 cups highest | up to 6 weeks | 
| Acceptability verbal questionnaire of Neuromuscular stimulation | yes / no answers, number of sessions participants say yes they accept or no not accept | up to 6 weeks | 
| Number of treatment sessions of Neuromuscular stimulation | number of treatment sessions 1 lowest and 18 highest | up to 6 weeks | 
| Duration of treatment sessions of Neuromuscular stimulation | number of weeks participants received Neuromuscular stimulation 1 week lowest, 6 weeks highest | up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty,, Immobility, Electrical Stimulation, High protein