Neuromuscular Electrical Stimulation Study (IMMI)

March 9, 2021 updated by: Nottingham University Hospitals NHS Trust

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Neuromuscular electrical stimulation (NMES) to one leg
  • 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

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,

Other Names:
  • Neuromuscular electrical stimulation with high protein ice cream supplementation
OTHER: High protein ice cream supplementation
  • 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

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,

Other Names:
  • Neuromuscular electrical stimulation with high protein ice cream supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
"Change from Baseline lower limb muscle strength at 6 weeks"
Hand grip strength
Time Frame: "Change from Baseline Hand grip strength at 6 weeks"
using a standard device
"Change from Baseline Hand grip strength at 6 weeks"
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).
"Change from Baseline lower limb muscle thickness at 6 weeks"
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
"Change from Baseline lower limb muscle control at 6 weeks"
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
"Change from Baseline functional independence at 6 weeks"and " 6 months"
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
"Change from Baseline functional independence at 6 weeks"and " 6 months"
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.
Change from Baseline functional independence at 6 weeks "and " 6 months"]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability measurement
Time Frame: "up to 6 weeks"
high number yes, low number no
"up to 6 weeks"
Pain/Visual analogue scores
Time Frame: "Change from Baseline functional independence at 6 weeks "
1 less pain, 10 severe pain
"Change from Baseline functional independence at 6 weeks "
Mortality Rate
Time Frame: At 6 months after recruitment
the number of participants who died within 6 months period after recruitment.
At 6 months after recruitment
Number of protein supplementation doses consumed
Time Frame: "up to 6 weeks"
How many cups participants consumed 1 cup lowest and 18 cups highest
"up to 6 weeks"
Acceptability verbal questionnaire of Neuromuscular stimulation
Time Frame: "up to 6 weeks"
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
Time Frame: "up to 6 weeks"
number of treatment sessions 1 lowest and 18 highest
"up to 6 weeks"
Duration of treatment sessions of Neuromuscular stimulation
Time Frame: "up to 6 weeks"
number of weeks participants received Neuromuscular stimulation 1 week lowest, 6 weeks highest
"up to 6 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Investigators

  • Study Chair: Maria Kofali, Nottingham University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

March 30, 2022

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (ACTUAL)

March 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20HC006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data (IPD) available only to those involved in the research project

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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