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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
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,
Lower limb muscle strength
using A hand-held dynamometer for both vastus lateralis and tibialis anterior muscles
Time frame: "Change from Baseline lower limb muscle strength at 6 weeks"
Hand grip strength
using a standard device
Time frame: "Change from Baseline Hand grip strength at 6 weeks"
Ultrasound
Ultrasound parameters of vastus lateralis and tibialis anterior muscles (thickness, pennation angle, echogenicity).
Time frame: "Change from Baseline lower limb muscle thickness at 6 weeks"
iEMG derived motor unit structure and function
intramuscular electromyography (iEMG) measures of muscle control
Time frame: "Change from Baseline lower limb muscle control at 6 weeks"
Elderly Mobility Scale
measuring 9 domains from very fit 1 to terminally ill 9
Time frame: "Change from Baseline functional independence at 6 weeks"and " 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
Time frame: "Change from Baseline functional independence at 6 weeks"and " 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.
Time frame: Change from Baseline functional independence at 6 weeks "and " 6 months"]
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Purpose
OTHER
Masking
NONE
Enrollment
66
Tolerability measurement
high number yes, low number no
Time frame: "up to 6 weeks"
Pain/Visual analogue scores
1 less pain, 10 severe pain
Time frame: "Change from Baseline functional independence at 6 weeks "
Mortality Rate
the number of participants who died within 6 months period after recruitment.
Time frame: At 6 months after recruitment
Number of protein supplementation doses consumed
How many cups participants consumed 1 cup lowest and 18 cups highest
Time frame: "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
Time frame: "up to 6 weeks"
Number of treatment sessions of Neuromuscular stimulation
number of treatment sessions 1 lowest and 18 highest
Time frame: "up to 6 weeks"
Duration of treatment sessions of Neuromuscular stimulation
number of weeks participants received Neuromuscular stimulation 1 week lowest, 6 weeks highest
Time frame: "up to 6 weeks"