SarcopeniaIMMINCT04792307
Neuromuscular Electrical Stimulation Study
A study testing Neuromuscular electrical stimulation , no high protein ice cream supplementation in people with Sarcopenia, run by Nottingham University Hospitals NHS Trust.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Neuromuscular electrical stimulation , no high protein ice cream supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >/=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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Neuromuscular electrical stimulation , no high protein ice cream supplementation
- Keywords
- Frailty,, Immobility, Electrical Stimulation, High protein
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation , no high protein ice cream supplementationOther
Also called Neuromuscular electrical stimulation with 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,
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Neuromuscular electrical stimulation , no high protein ice cream supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb muscle strength
using A hand-held dynamometer for both vastus lateralis and tibialis anterior muscles
Measured: "Change from Baseline lower limb muscle strength at 6 weeks"
Hand grip strength
using a standard device
Measured: "Change from Baseline Hand grip strength at 6 weeks"
Ultrasound
Ultrasound parameters of vastus lateralis and tibialis anterior muscles (thickness, pennation angle, echogenicity).
Measured: "Change from Baseline lower limb muscle thickness at 6 weeks"
iEMG derived motor unit structure and function
intramuscular electromyography (iEMG) measures of muscle control
Measured: "Change from Baseline lower limb muscle control at 6 weeks"
Elderly Mobility Scale
measuring 9 domains from very fit 1 to terminally ill 9
Measured: "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
Measured: "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.
Measured: Change from Baseline functional independence at 6 weeks "and " 6 months"]
Secondary outcomes (7)
Tolerability measurement
high number yes, low number no
Measured: "up to 6 weeks"
Pain/Visual analogue scores
1 less pain, 10 severe pain
Measured: "Change from Baseline functional independence at 6 weeks "
Mortality Rate
the number of participants who died within 6 months period after recruitment.
Measured: At 6 months after recruitment
Number of protein supplementation doses consumed
How many cups participants consumed 1 cup lowest and 18 cups highest
Measured: "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
Measured: "up to 6 weeks"
Number of treatment sessions of Neuromuscular stimulation
number of treatment sessions 1 lowest and 18 highest
Measured: "up to 6 weeks"
Duration of treatment sessions of Neuromuscular stimulation
number of weeks participants received Neuromuscular stimulation 1 week lowest, 6 weeks highest
Measured: "up to 6 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- will randomly allocate participants offering half of them additional protein supplementation over and above their ordinary diet
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Kofali, Study chair, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792307
- Sponsor's protocol ID
- 20HC006
- Acronym
- IMMI
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) available only to those involved in the research project
Publications
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.
PubMed 30312372Wilkinson 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.
PubMed 30048806Rudrappa 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.
PubMed 27610086Anthony 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.
PubMed 24089670Welch 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.
PubMed 33098419Dacombe 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
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.
PubMed 27748503Symons 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.
PubMed 19699838Martin 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.
PubMed 16645295Lunt 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.
PubMed 32706848Tarquinio 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.
PubMed 25140439Collin 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.
PubMed 3403500Gladman 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.
PubMed 8310887Rockwood 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.
PubMed 16129869Nasreddine 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.
PubMed 15817019
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility RCT of Neuromuscular Electrical Stimulation; an Intervention to Maintain and Improve neuroMuscular Function During Periods of Immobility
- ClinicalTrials.gov ID
- NCT04792307
- Acronym / sponsor ID
- IMMI / 20HC006
- Conditions
- Sarcopenia
- Keywords
- Frailty,, Immobility, Electrical Stimulation, High protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- will randomly allocate participants offering half of them additional protein supplementation over and above their ordinary diet
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation (NMES) to one leg | Other | Other: Neuromuscular electrical stimulation , no high protein ice cream supplementation* NMES left leg, no high protein ice cream supplementation * NMES right leg, no high protein ice cream supplementation |
| High protein ice cream supplementation | Other | Other: Neuromuscular electrical stimulation , no high protein ice cream supplementation* NMES left leg, high protein ice cream supplementation * NMES right leg, high protein ice cream supplementation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- >/=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
Key exclusion criteria (14 listed)
- Unable to give valid informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulation , no high protein ice cream supplementationAlso: Neuromuscular electrical stimulation with high protein ice cream supplementationA 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 | High protein ice cream supplementation, Neuromuscular electrical stimulation (NMES) to one leg |
Primary outcome
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
Hand grip strength
Time frame: "Change from Baseline Hand grip strength at 6 weeks"
using a standard device
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
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
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
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.
7 secondary outcomes
Tolerability measurement
Time frame: "up to 6 weeks"
Pain/Visual analogue scores
Time frame: "Change from Baseline functional independence at 6 weeks "
Mortality Rate
Time frame: At 6 months after recruitment
Number of protein supplementation doses consumed
Time frame: "up to 6 weeks"
Acceptability verbal questionnaire of Neuromuscular stimulation
Time frame: "up to 6 weeks"
Number of treatment sessions of Neuromuscular stimulation
Time frame: "up to 6 weeks"
Duration of treatment sessions of Neuromuscular stimulation
Time frame: "up to 6 weeks"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 30312372Cruz-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.
- Background: PubMed 30048806Wilkinson 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.
- Background: PubMed 27610086Rudrappa 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.
- Background: PubMed 24089670Anthony 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.
- Background: PubMed 33098419Welch 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.
- BackgroundDacombe 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: PubMed 27748503Jones 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.
- Background: PubMed 19699838Symons 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.
- Background: PubMed 16645295Martin 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.
- Background: PubMed 32706848Lunt 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.
- Background: PubMed 25140439Tarquinio 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.
- Background: PubMed 3403500Collin 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.
- Individual participant dataSharing planned: No. individual participant data (IPD) available only to those involved in the research project
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Kofali study chair
Nottingham University Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation , no high protein ice cream supplementation in people with Sarcopenia, run by Nottingham University Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Gladman, Prof. (0441158230242, John.Gladman@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb muscle strength (time frame: "Change from Baseline lower limb muscle strength at 6 weeks"). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04792307, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.