Spinal Cord InjuriesNCT05249985
Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI
A study testing NMES and Protein in people with Spinal Cord Injuries, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The aim of this pilot study is to explore how body composition, circulating markers of metabolic health and skin integrity in persons with a spinal cord injury (SCI) are affected by 12 weeks of quadriceps neuromuscular electrical stimulation (NMES) resistance training. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- NMES and Protein
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2022to 15 Feb 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Motor complete spinal cord injury
- Time since injury injury >1 year
Who cannot join
- Spinal cord injury below T10 vertebrae
- Habitual protein intake exceeding 2g / kg body mass / day
- Having used NMES resistance training once or more per week in the last six months
- Lactose intolerant
- Any disease or medication that means the participant should not exercise
- Participation in a study involving ionising radiation in the previous 12 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE113TU
About this study
Official title: Effects of Protein Supplementation and Neuromuscular Electrical Stimulation on Fat-free Mass in Persons With Motor Complete Spinal Cord Injury: a Pilot Study
The aim of this pilot study is to explore how body composition, circulating markers of metabolic health and skin integrity in persons with a spinal cord injury (SCI) are affected by 12 weeks of quadriceps neuromuscular electrical stimulation (NMES) resistance training. The novel element of this study is that one group will be given additional daily protein supplementation in addition to the NMES training (treatment group), whereas the other group will only perform the NMES training (control group). The investigators hypothesise that NMES in combination with protein results in larger improvements in the aforementioned outcomes compared with NMES alone.
Read the detailed description
A spinal cord injury (SCI) is a debilitating condition, with paralysis below the lesion level as one of the main hallmarks. As a result of paralysis, together with decreased levels of physical activity and impairment-specific co-morbidities such as autonomic dysfunction, persons with SCI have a markedly reduced muscle mass. Being the major site for glucose disposal, skeletal muscle is key for the maintenance of metabolic health, while it also helps with weight management by contributing to energy expenditure at rest. As such, effective strategies to restore muscle mass in persons with SCI are warranted and can have a significant impact on metabolic health and chronic disease risk in this population.
While resistance training is widely recognised as an effective intervention to increase muscle mass in able-bodied individuals, paralysis in the lower limbs of persons with SCI precludes the use of traditional resistance training in this population. NMES has been developed to overcome this barrier and allows persons with SCI to engage in resistance exercise. Notwithstanding the evidence supporting the use of NMES on its own, combined interventions may further enhance its potential to improve health and physical function. Indeed, in the more widely studied population of older adults, that is also at risk for sarcopenia (loss of skeletal muscle mass and strength), increasing daily protein intake enhances the efficacy of resistance training to increase muscle mass.
The primary objective of this study is to determine the impact of a 12-week intervention of NMES in combination with protein supplementation when compared with NMES alone on fat free mass in the legs. Secondary objectives are to investigate the impact of the intervention on 1) markers of cardiometabolic health, namely glucose tolerance and fasting plasma lipid concentrations, 2) resting metabolic rate, and 3) skin blood flow at the level of the sacrum in response to experimental pressure. Outcomes related to tertiary objectives include perceived quality of life, neuropathic pain, body image, sleep quality and spasms; as well as free-living energy balance, physical activity and feasibility outcomes related to recruitment, adherence and participant' experiences with the intervention. It is hypothesised that NMES in combination with protein results in larger improvements in the aforementioned outcomes compared with NMES alone.
- Conditions
- Spinal Cord Injuries
- Being tested
- NMES, Protein
- Keywords
- Protein, NMES
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.
ProteinDietary supplement
Participants will consume a daily protein supplement
| Study group | Role | What they receive |
|---|---|---|
| NMES plus protein supplementation | Experimental | Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps in addition to a daily protein supplement. Receives: Device: NMES; Dietary Supplement: Protein |
| NMES | Active comparator | Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps. Receives: Device: NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density
Dual x-ray absorptiometry
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in lean soft tissue mass
Dual x-ray absorptiometry
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in fat mass
Dual x-ray absorptiometry
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary outcomes (6)
Change in glucose tolerance
Oral glucose tolerance test
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in insulin resistance
Oral glucose tolerance test
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in fasting plasma lipid concentrations
Resting blood sample
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in fasting circulating C-reactive protein
Resting blood sample
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in sacral skin blood flow
Doppler flowmetry
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in resting metabolic rate
Expired air analysis
Measured: Pre-intervention (baseline) and at 1 week post-12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start5 Apr 2022
- Primary completion20 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study. This will be either (a) NMES plus protein supplementation, or (b) NMES only.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Danone Nutricia
- Responsible party
- Principal investigator, Professor Victoria Tolfrey, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249985
- Sponsor's protocol ID
- 3176
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protein Supplementation and Neuromuscular Electrical Stimulation on Fat-free Mass in Persons With Motor Complete Spinal Cord Injury: a Pilot Study
- ClinicalTrials.gov ID
- NCT05249985
- Acronym / sponsor ID
- 3176
- Conditions
- Spinal Cord Injuries
- Keywords
- Protein, NMES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- McMaster University, Danone Nutricia
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 22 Feb 2022 (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.
The aim of this pilot study is to explore how body composition, circulating markers of metabolic health and skin integrity in persons with a spinal cord injury (SCI) are affected by 12 weeks of quadriceps neuromuscular electrical stimulation (NMES) resistance training. The novel element of this study is that one group will be given additional daily protein supplementation in addition to the NMES training (treatment group), whereas the other group will only perform the NMES training (control group). The investigators hypothesise that NMES in combination with protein results in larger improvements in the aforementioned outcomes compared with NMES alone.
Detailed description
A spinal cord injury (SCI) is a debilitating condition, with paralysis below the lesion level as one of the main hallmarks. As a result of paralysis, together with decreased levels of physical activity and impairment-specific co-morbidities such as autonomic dysfunction, persons with SCI have a markedly reduced muscle mass. Being the major site for glucose disposal, skeletal muscle is key for the maintenance of metabolic health, while it also helps with weight management by contributing to energy expenditure at rest. As such, effective strategies to restore muscle mass in persons with SCI are warranted and can have a significant impact on metabolic health and chronic disease risk in this population.
While resistance training is widely recognised as an effective intervention to increase muscle mass in able-bodied individuals, paralysis in the lower limbs of persons with SCI precludes the use of traditional resistance training in this population. NMES has been developed to overcome this barrier and allows persons with SCI to engage in resistance exercise. Notwithstanding the evidence supporting the use of NMES on its own, combined interventions may further enhance its potential to improve health and physical function. Indeed, in the more widely studied population of older adults, that is also at risk for sarcopenia (loss of skeletal muscle mass and strength), increasing daily protein intake enhances the efficacy of resistance training to increase muscle mass.
The primary objective of this study is to determine the impact of a 12-week intervention of NMES in combination with protein supplementation when compared with NMES alone on fat free mass in the legs. Secondary objectives are to investigate the impact of the intervention on 1) markers of cardiometabolic health, namely glucose tolerance and fasting plasma lipid concentrations, 2) resting metabolic rate, and 3) skin blood flow at the level of the sacrum in response to experimental pressure. Outcomes related to tertiary objectives include perceived quality of life, neuropathic pain, body image, sleep quality and spasms; as well as free-living energy balance, physical activity and feasibility outcomes related to recruitment, adherence and participant' experiences with the intervention. It is hypothesised that NMES in combination with protein results in larger improvements in the aforementioned outcomes compared with NMES alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study. This will be either (a) NMES plus protein supplementation, or (b) NMES only.
| Arm | Type | Receives |
|---|---|---|
| NMES plus protein supplementation | Experimental | Device: NMES, Dietary Supplement: ProteinParticipants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps in addition to a daily protein supplement. |
| NMES | Active comparator | Device: NMESParticipants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Motor complete spinal cord injury
- Time since injury injury >1 year
Key exclusion criteria (6 listed)
- Spinal cord injury below T10 vertebrae
- Habitual protein intake exceeding 2g / kg body mass / day
- Having used NMES resistance training once or more per week in the last six months
- Lactose intolerant
- Any disease or medication that means the participant should not exercise
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 |
|---|---|---|
| NMESParticipants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps. | Device | NMES, NMES plus protein supplementation |
| ProteinParticipants will consume a daily protein supplement | Dietary supplement | NMES plus protein supplementation |
Primary outcome
Change in bone mineral density
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Dual x-ray absorptiometry
Change in lean soft tissue mass
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Dual x-ray absorptiometry
Change in fat mass
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Dual x-ray absorptiometry
6 secondary outcomes
Change in glucose tolerance
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in insulin resistance
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in fasting plasma lipid concentrations
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in fasting circulating C-reactive protein
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in sacral skin blood flow
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in resting metabolic rate
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES and Protein in people with Spinal Cord Injuries, run by Loughborough University at 1 site in United Kingdom.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density (time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2024.