CompletedNot Applicable

Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI

United Kingdom30 participantsStarted 2022-04-05

Plain-language 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. 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Motor complete spinal cord injury * Time since injury injury \>1 year Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in bone mineral density

Timeframe: Pre-intervention (baseline) and at 1 week post-12 week intervention

Change in lean soft tissue mass

Timeframe: Pre-intervention (baseline) and at 1 week post-12 week intervention

Change in fat mass

Timeframe: Pre-intervention (baseline) and at 1 week post-12 week intervention

Trial details

NCT IDNCT05249985

SponsorLoughborough University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-20

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in bone mineral density

Timeframe: Pre-intervention (baseline) and at 1 week post-12 week intervention

Change in lean soft tissue mass

Timeframe: Pre-intervention (baseline) and at 1 week post-12 week intervention

Change in fat mass

Timeframe: Pre-intervention (baseline) and at 1 week post-12 week intervention