Clinical trial NCT04792307: Neuromuscular Electrical Stimulation Study
Official title: Feasibility RCT of Neuromuscular Electrical Stimulation; an Intervention to Maintain and Improve neuroMuscular Function During Periods of Immobility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: Frailty,
Immobility
Electrical Stimulation
High protein
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: will randomly allocate participants offering half of them additional protein supplementation over and above their ordinary diet
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower limb muscle strength
timeFrame: "Change from Baseline lower limb muscle strength at 6 weeks"
measure: Hand grip strength
timeFrame: "Change from Baseline Hand grip strength at 6 weeks"
measure: Ultrasound
timeFrame: "Change from Baseline lower limb muscle thickness at 6 weeks"
measure: iEMG derived motor unit structure and function
timeFrame: "Change from Baseline lower limb muscle control at 6 weeks"
measure: Elderly Mobility Scale
timeFrame: "Change from Baseline functional independence at 6 weeks"and " 6 months"
measure: Nottingham Extended ADL
timeFrame: "Change from Baseline functional independence at 6 weeks"and " 6 months"
measure: Disability and functional independence using Barthel ADL score.
timeFrame: Change from Baseline functional independence at 6 weeks "and " 6 months"]
Secondary outcomes:
measure: Tolerability measurement
timeFrame: "up to 6 weeks"
measure: Pain/Visual analogue scores
timeFrame: "Change from Baseline functional independence at 6 weeks "
measure: Mortality Rate
timeFrame: At 6 months after recruitment
measure: Number of protein supplementation doses consumed
timeFrame: "up to 6 weeks"
measure: Acceptability verbal questionnaire of Neuromuscular stimulation
timeFrame: "up to 6 weeks"
measure: Number of treatment sessions of Neuromuscular stimulation
timeFrame: "up to 6 weeks"
measure: Duration of treatment sessions of Neuromuscular stimulation
timeFrame: "up to 6 weeks"
Other outcomes:
Locations:
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Maria Kofali
role: STUDY_CHAIR
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