Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: NMES; Dietary supplement: Protein

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom, LE113TU
      • Loughborough University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Automatic blood pressure cuff	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in daily energy intake	3 day food diary	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in physical activity	Wrist-worn accelerometer	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in physical activity	Leisure time physical activity questionnaire	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in sleep efficiency and duration	Wrist-worn accelerometer	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)	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in muscle spasticity	The Spinal Cord Injury Spasticity Evaluation Tool	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in mental health	5-item Mental Health Inventory	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in neuropathic pain	Neuropathic Pain Questionnaire	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in body image	Body Image Satisfaction Questionnaire	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in skinfold thickness	Measured in millimetre	Pre-intervention (baseline) and at 1 week post-12 week intervention
Height	Measured in meters	Pre-intervention only
Change in waist and hip circumference	Measured in centimeters to provide a waist-to-hip ratio	Pre-intervention (baseline) and at 1 week post-12 week intervention
Change in body weight	Measured in kilograms	Pre-intervention (baseline) and at 1 week post-12 week intervention

Collaborators and Investigators

• Sponsor: Loughborough University
• Collaborators: McMaster University; Danone Nutricia

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Protein; NMES
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 3176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No