Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249985
• Other study ID #: 3176
• Status: Completed
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 15, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (3)

Lead Sponsor	Collaborator
Loughborough University	Danone Nutricia, McMaster University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood pressure	Automatic blood pressure cuff	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Change in daily energy intake	3 day food diary	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Change in physical activity	Wrist-worn accelerometer	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Change in physical activity	Leisure time physical activity questionnaire	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Change in sleep efficiency and duration	Wrist-worn accelerometer	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	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
Other	Change in muscle spasticity	The Spinal Cord Injury Spasticity Evaluation Tool	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Change in mental health	5-item Mental Health Inventory	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Change in neuropathic pain	Neuropathic Pain Questionnaire	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Change in body image	Body Image Satisfaction Questionnaire	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Change in skinfold thickness	Measured in millimetre	Pre-intervention (baseline) and at 1 week post-12 week intervention
Other	Height	Measured in meters	Pre-intervention only
Other	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
Other	Change in body weight	Measured in kilograms	Pre-intervention (baseline) and at 1 week post-12 week intervention
Primary	Change in bone mineral density	Dual x-ray absorptiometry	Pre-intervention (baseline) and at 1 week post-12 week intervention
Primary	Change in lean soft tissue mass	Dual x-ray absorptiometry	Pre-intervention (baseline) and at 1 week post-12 week intervention
Primary	Change in fat mass	Dual x-ray absorptiometry	Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary	Change in glucose tolerance	Oral glucose tolerance test	Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary	Change in insulin resistance	Oral glucose tolerance test	Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary	Change in fasting plasma lipid concentrations	Resting blood sample	Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary	Change in fasting circulating C-reactive protein	Resting blood sample	Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary	Change in sacral skin blood flow	Doppler flowmetry	Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary	Change in resting metabolic rate	Expired air analysis	Pre-intervention (baseline) and at 1 week post-12 week intervention