Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI

NCT ID: NCT05249985

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2024-02-15

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NMES

Intervention Type: DEVICE

Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.

Protein

Intervention Type: DIETARY_SUPPLEMENT

Participants will consume a daily protein supplement

NMES

Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.

Group Type: ACTIVE_COMPARATOR

NMES

Intervention Type: DEVICE

Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.

Interventions

NMES

Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.

Intervention Type: DEVICE

Protein

Participants will consume a daily protein supplement

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

Danone Nutricia

INDUSTRY

Sponsor Role: collaborator

Loughborough University

OTHER

Sponsor Role: lead

Responsible Party

Professor Victoria Tolfrey

Professor of Applied Disability Sport Director of the Peter Harrison Centre for Disability Sport

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Loughborough University

Loughborough, Leicestershire, United Kingdom

Countries

United Kingdom

Other Identifiers

3176

Identifier Type: -

Identifier Source: org_study_id