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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular electrical stimulation (NMES) to one leg | Other |
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| High protein ice cream supplementation | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation , no high protein ice cream supplementation | Other | 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, |
| 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 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 | "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. |
| 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 " |
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Inclusion Criteria:
Exclusion Criteria:
Unable to give valid informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Gladman, Prof. | Contact | 0441158230242 | John.Gladman@nottingham.ac.uk | |
| saleh aloraibi, PhD | Contact | 00447459274400 | Saleh.Aloraibi@nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Maria Kofali | Nottingham University Hospitals NHS Trust | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30312372 | Background | Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. | |
| 30048806 |
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individual participant data (IPD) available only to those involved in the research project
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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will randomly allocate participants offering half of them additional protein supplementation over and above their ordinary diet
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| Change from Baseline functional independence at 6 weeks "and " 6 months"] |
| 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" |
| Background |
| Wilkinson DJ, Piasecki M, Atherton PJ. The age-related loss of skeletal muscle mass and function: Measurement and physiology of muscle fibre atrophy and muscle fibre loss in humans. Ageing Res Rev. 2018 Nov;47:123-132. doi: 10.1016/j.arr.2018.07.005. Epub 2018 Jul 23. |
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| 19699838 | Background | Symons TB, Sheffield-Moore M, Wolfe RR, Paddon-Jones D. A moderate serving of high-quality protein maximally stimulates skeletal muscle protein synthesis in young and elderly subjects. J Am Diet Assoc. 2009 Sep;109(9):1582-6. doi: 10.1016/j.jada.2009.06.369. |
| 16645295 | Background | Martin HJ, Yule V, Syddall HE, Dennison EM, Cooper C, Aihie Sayer A. Is hand-held dynamometry useful for the measurement of quadriceps strength in older people? A comparison with the gold standard Bodex dynamometry. Gerontology. 2006;52(3):154-9. doi: 10.1159/000091824. |
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| 25140439 | Background | Tarquinio C, Kivits J, Minary L, Coste J, Alla F. Evaluating complex interventions: perspectives and issues for health behaviour change interventions. Psychol Health. 2015 Jan;30(1):35-51. doi: 10.1080/08870446.2014.953530. Epub 2014 Oct 21. |
| 3403500 | Background | Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3. doi: 10.3109/09638288809164103. |
| 8310887 | Background | Gladman JR, Lincoln NB, Adams SA. Use of the extended ADL scale with stroke patients. Age Ageing. 1993 Nov;22(6):419-24. doi: 10.1093/ageing/22.6.419. |
| 16129869 | Background | Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051. |
| 15817019 | Background | Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. |
| Background | Elia M RC, Stratton R, Todorovic V, Evans L, Farrer K. Malnutrition Universal Screening Tool (MUST) for adults www.bapen.org.uk 2004 |
| 25083133 | Background | Laufer Y, Shtraker H, Elboim Gabyzon M. The effects of exercise and neuromuscular electrical stimulation in subjects with knee osteoarthritis: a 3-month follow-up study. Clin Interv Aging. 2014 Jul 17;9:1153-61. doi: 10.2147/CIA.S64104. eCollection 2014. |
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| 27932876 | Background | Chen RC, Li XY, Guan LL, Guo BP, Wu WL, Zhou ZQ, Huo YT, Chen X, Zhou LQ. Effectiveness of neuromuscular electrical stimulation for the rehabilitation of moderate-to-severe COPD: a meta-analysis. Int J Chron Obstruct Pulmon Dis. 2016 Nov 28;11:2965-2975. doi: 10.2147/COPD.S120555. eCollection 2016. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |