An interventional study of NMES and Protein in Spinal Cord Injuries, sponsored by Loughborough University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by Loughborough University · Not applicable, Interventional, and Basic science
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 30 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Loughborough University is the lead sponsor of 71 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps in addition to a daily protein supplement.
Device: NMES · Dietary Supplement: Protein
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.
Device: NMES
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.
Participants will consume a daily protein supplement
Change in bone mineral density
Dual x-ray absorptiometry
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in lean soft tissue mass
Dual x-ray absorptiometry
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in fat mass
Dual x-ray absorptiometry
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in glucose tolerance
Oral glucose tolerance test
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in insulin resistance
Oral glucose tolerance test
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in fasting plasma lipid concentrations
Resting blood sample
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in fasting circulating C-reactive protein
Resting blood sample
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in sacral skin blood flow
Doppler flowmetry
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in resting metabolic rate
Expired air analysis
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in blood pressure
Automatic blood pressure cuff
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in daily energy intake
3 day food diary
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in physical activity
Wrist-worn accelerometer
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in physical activity
Leisure time physical activity questionnaire
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in sleep efficiency and duration
Wrist-worn accelerometer
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in sleep quality
Sleep Quality Scale (available answers include: rarely, sometimes, often, almost always)
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in muscle spasticity
The Spinal Cord Injury Spasticity Evaluation Tool
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in mental health
5-item Mental Health Inventory
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in neuropathic pain
Neuropathic Pain Questionnaire
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in body image
Body Image Satisfaction Questionnaire
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in skinfold thickness
Measured in millimetre
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Height
Measured in meters
Time frame: Pre-intervention only
Change in waist and hip circumference
Measured in centimeters to provide a waist-to-hip ratio
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in body weight
Measured in kilograms
Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Loughborough University