Neuromuscular Electrical Stimulation Study

NCT04792307 | Unknown DMC

• 1 other identifier: 20HC006
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcopenia

Keywords

Frailty,; Immobility; Electrical Stimulation; High protein

Outcome Measures

Primary Outcomes (7)

• 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.

  Change from Baseline functional independence at 6 weeks "and " 6 months"]

Secondary Outcomes (7)

• Tolerability measurement

  "up to 6 weeks"

• Pain/Visual analogue scores

  "Change from Baseline functional independence at 6 weeks "

• Mortality Rate

  At 6 months after recruitment

• Number of protein supplementation doses consumed

  "up to 6 weeks"

• Acceptability verbal questionnaire of Neuromuscular stimulation

  "up to 6 weeks"

Study Arms (2)

Neuromuscular electrical stimulation (NMES) to one leg

OTHER

* NMES left leg, no high protein ice cream supplementation * NMES right leg, no high protein ice cream supplementation

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

High protein ice cream supplementation

OTHER

* NMES left leg, high protein ice cream supplementation * NMES right leg, high protein ice cream supplementation

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

Interventions

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,

Also known as: Neuromuscular electrical stimulation with high protein ice cream supplementation

High protein ice cream supplementation; Neuromuscular electrical stimulation (NMES) to one leg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>/=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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Related Publications (19)

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  PMID: 30312372 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.

  PMID: 30048806 BACKGROUND

• 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.

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• 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.

  PMID: 24089670 BACKGROUND

• 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. 2021 Feb 26;50(2):394-404. doi: 10.1093/ageing/afaa209.

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• 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

  BACKGROUND

• 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(10):CD009419. doi: 10.1002/14651858.CD009419.pub3.

  PMID: 27748503 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.

  PMID: 19699838 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.

  PMID: 16645295 BACKGROUND

• 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.

  PMID: 32706848 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.

  PMID: 25140439 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.

  PMID: 3403500 BACKGROUND

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• 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.

  PMID: 16129869 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.

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• Stratton RJ, Hackston A, Longmore D, Dixon R, Price S, Stroud M, King C, Elia M. Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr. 2004 Nov;92(5):799-808. doi: 10.1079/bjn20041258.

  PMID: 15533269 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.

  PMID: 25083133 BACKGROUND

• 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.

  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.

  PMID: 27932876 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Maria Kofali

  Nottingham University Hospitals NHS Trust

  STUDY CHAIR

Central Study Contacts

John Gladman, Prof.

CONTACT

0441158230242; John.Gladman@nottingham.ac.uk

saleh aloraibi, PhD

CONTACT

00447459274400; Saleh.Aloraibi@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: will randomly allocate participants offering half of them additional protein supplementation over and above their ordinary diet

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share