Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Protein Supplementation and Neuromuscular Electrical Stimulation on Fat-free Mass in Persons With Motor Complete Spinal Cord Injury: a Pilot Study

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: NMES
* Dietary Supplement: Protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMES plus protein supplementation<br>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<br>* Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.<br>Dietary Supplement: Protein<br>* Participants will consume a daily protein supplement<br>|
| Active Comparator: NMES<br>Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps. | Device: NMES<br>* Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density | Dual x-ray absorptiometry | Pre-intervention (baseline) and at 1 week post-12 week intervention | 
| Change in lean soft tissue mass | Dual x-ray absorptiometry | Pre-intervention (baseline) and at 1 week post-12 week intervention | 
| Change in fat mass | Dual x-ray absorptiometry | Pre-intervention (baseline) and at 1 week post-12 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose tolerance | Oral glucose tolerance test | Pre-intervention (baseline) and at 1 week post-12 week intervention | 
| Change in insulin resistance | Oral glucose tolerance test | Pre-intervention (baseline) and at 1 week post-12 week intervention | 
| Change in fasting plasma lipid concentrations | Resting blood sample | Pre-intervention (baseline) and at 1 week post-12 week intervention | 
| Change in fasting circulating C-reactive protein | Resting blood sample | Pre-intervention (baseline) and at 1 week post-12 week intervention | 
| Change in sacral skin blood flow | Doppler flowmetry | Pre-intervention (baseline) and at 1 week post-12 week intervention | 
| Change in resting metabolic rate | Expired air analysis | Pre-intervention (baseline) and at 1 week post-12 week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein, NMES