Clinical trial NCT05249985: Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Protein
NMES
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Danone Nutricia
First posted: 2022-02-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in bone mineral density
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in lean soft tissue mass
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in fat mass
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary outcomes:
measure: Change in glucose tolerance
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in insulin resistance
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in fasting plasma lipid concentrations
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in fasting circulating C-reactive protein
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in sacral skin blood flow
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in resting metabolic rate
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Other outcomes:
measure: Change in blood pressure
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in daily energy intake
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in physical activity
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in physical activity
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in sleep efficiency and duration
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in sleep quality
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in muscle spasticity
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in mental health
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in neuropathic pain
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in body image
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in skinfold thickness
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Height
timeFrame: Pre-intervention only
measure: Change in waist and hip circumference
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
measure: Change in body weight
timeFrame: Pre-intervention (baseline) and at 1 week post-12 week intervention
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References: