Feasibility RCT of Neuromuscular Electrical Stimulation; an Intervention to Maintain and Improve neuroMuscular Function During Periods of Immobility
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 66
- Primary Endpoint
- Elderly Mobility Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Elderly Mobility Scale
Time Frame: "Change from Baseline functional independence at 6 weeks"and " 6 months"
measuring 9 domains from very fit 1 to terminally ill 9
Lower limb muscle strength
Time Frame: "Change from Baseline lower limb muscle strength at 6 weeks"
using A hand-held dynamometer for both vastus lateralis and tibialis anterior muscles
Disability and functional independence using Barthel ADL score.
Time Frame: Change from Baseline functional independence at 6 weeks "and " 6 months"]
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.
Nottingham Extended ADL
Time Frame: "Change from Baseline functional independence at 6 weeks"and " 6 months"
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
Ultrasound
Time Frame: "Change from Baseline lower limb muscle thickness at 6 weeks"
Ultrasound parameters of vastus lateralis and tibialis anterior muscles (thickness, pennation angle, echogenicity).
iEMG derived motor unit structure and function
Time Frame: "Change from Baseline lower limb muscle control at 6 weeks"
intramuscular electromyography (iEMG) measures of muscle control
Hand grip strength
Time Frame: "Change from Baseline Hand grip strength at 6 weeks"
using a standard device
Secondary Outcomes
- Tolerability measurement("up to 6 weeks")
- Acceptability verbal questionnaire of Neuromuscular stimulation("up to 6 weeks")
- Number of treatment sessions of Neuromuscular stimulation("up to 6 weeks")
- Mortality Rate(At 6 months after recruitment)
- Pain/Visual analogue scores("Change from Baseline functional independence at 6 weeks ")
- Number of protein supplementation doses consumed("up to 6 weeks")
- Duration of treatment sessions of Neuromuscular stimulation("up to 6 weeks")