Neuromuscular Electrical Stimulation Study

Sarcopenia Clinical Trial

— IMMI  

Official title:

Feasibility RCT of Neuromuscular Electrical Stimulation; an Intervention to Maintain and Improve neuroMuscular Function During Periods of Immobility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04792307
• Other study ID #: 20HC006
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2021
• Source: Nottingham University Hospitals NHS Trust
• Contact: John Gladman, Prof.
• Phone: 0441158230242
• Email: John.Gladman[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Neuromuscular electrical stimulation , no high protein ice cream supplementation
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,

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

References & Publications (19)

Anthony K, Robinson K, Logan P, Gordon AL, Harwood RH, Masud T. Chair-based exercises for frail older people: a systematic review. Biomed Res Int. 2013;2013:309506. doi: 10.1155/2013/309506. Epub 2013 Sep 9. Review. — View Citation

Asakawa Y, Jung JH, Koh SE. Neuromuscular electrical stimulation improves strength, pain and weight distribution on patients with knee instability post surgery. Physical therapy rehabilitation science. 2014;3(2):112-8.

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. eCollection 2016. Review. — View Citation

Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3. — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère 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. Erratum in: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

Dacombe PJ, Clement RGE, Woodard J, Sahota O. Poor nutritional intake in acute fractured neck of femur admission - is this well described clinical problem still under-managed? International Journal of Surgery (Abtracts) 2010 : 8 ; 501-578

Elia M RC, Stratton R, Todorovic V, Evans L, Farrer K. Malnutrition Universal Screening Tool (MUST) for adults www.bapen.org.uk 2004

Gladman JR, Lincoln NB, Adams SA. Use of the extended ADL scale with stroke patients. Age Ageing. 1993 Nov;22(6):419-24. — View Citation

Jones S, Man WD, Gao W, Higginson IJ, Wilcock A, Maddocks M. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2016 Oct 17;10:CD009419. Review. — View Citation

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. — View Citation

Lunt E, Ong T, Gordon AL, Greenhaff PL, Gladman JRF. The clinical usefulness of muscle mass and strength measures in older people: a systematic review. Age Ageing. 2021 Jan 8;50(1):88-95. doi: 10.1093/ageing/afaa123. — View Citation

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. — View Citation

Nasreddine ZS, Phillips NA, Bédirian 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. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

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. — View Citation

Rudrappa SS, Wilkinson DJ, Greenhaff PL, Smith K, Idris I, Atherton PJ. Human Skeletal Muscle Disuse Atrophy: Effects on Muscle Protein Synthesis, Breakdown, and Insulin Resistance-A Qualitative Review. Front Physiol. 2016 Aug 25;7:361. doi: 10.3389/fphys.2016.00361. eCollection 2016. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Welch C, Majid Z, Greig C, Gladman J, Masud T, Jackson T. Interventions to ameliorate reductions in muscle quantity and function in hospitalised older adults: a systematic review towards acute sarcopenia treatment. Age Ageing. 2020 Oct 24. pii: afaa209. doi: 10.1093/ageing/afaa209. [Epub ahead of print] — View Citation

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. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"
Primary	Hand grip strength	using a standard device	"Change from Baseline Hand grip strength at 6 weeks"
Primary	Ultrasound	Ultrasound parameters of vastus lateralis and tibialis anterior muscles (thickness, pennation angle, echogenicity).	"Change from Baseline lower limb muscle thickness at 6 weeks"
Primary	iEMG derived motor unit structure and function	intramuscular electromyography (iEMG) measures of muscle control	"Change from Baseline lower limb muscle control at 6 weeks"
Primary	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"
Primary	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"
Primary	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.	Change from Baseline functional independence at 6 weeks "and " 6 months"]
Secondary	Tolerability measurement	high number yes, low number no	"up to 6 weeks"
Secondary	Pain/Visual analogue scores	1 less pain, 10 severe pain	"Change from Baseline functional independence at 6 weeks "
Secondary	Mortality Rate	the number of participants who died within 6 months period after recruitment.	At 6 months after recruitment
Secondary	Number of protein supplementation doses consumed	How many cups participants consumed 1 cup lowest and 18 cups highest	"up to 6 weeks"
Secondary	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"
Secondary	Number of treatment sessions of Neuromuscular stimulation	number of treatment sessions 1 lowest and 18 highest	"up to 6 weeks"
Secondary	Duration of treatment sessions of Neuromuscular stimulation	number of weeks participants received Neuromuscular stimulation 1 week lowest, 6 weeks highest	"up to 6 weeks"