Neuromuscular Electrical Stimulation Study (IMMI)
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
66 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
saleh aloraibi, PhD; John Gladman, Prof.
Data sourced from clinicaltrials.gov
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