Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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.
    

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.
    

Intervention name(s): NMES; Protein
Intervention type(s): Device; Dietary Supplement
Intervention description(s): Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.; Participants will consume a daily protein supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Basic Science
Keywords: Protein; NMES