Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI

NCT05249985 | Completed

• 1 other identifier: 3176
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Protein; NMES

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in glucose tolerance

  Pre-intervention (baseline) and at 1 week post-12 week intervention

• Change in insulin resistance

  Pre-intervention (baseline) and at 1 week post-12 week intervention

• Change in fasting plasma lipid concentrations

  Pre-intervention (baseline) and at 1 week post-12 week intervention

• Change in fasting circulating C-reactive protein

  Pre-intervention (baseline) and at 1 week post-12 week intervention

• Change in sacral skin blood flow

  Pre-intervention (baseline) and at 1 week post-12 week intervention

Other Outcomes (14)

• Change in blood pressure

  Pre-intervention (baseline) and at 1 week post-12 week intervention

• Change in daily energy intake

  Pre-intervention (baseline) and at 1 week post-12 week intervention

• Change in physical activity

  Pre-intervention (baseline) and at 1 week post-12 week intervention

Study Arms (2)

NMES plus protein supplementation

EXPERIMENTAL

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; Dietary Supplement: Protein

NMES

ACTIVE COMPARATOR

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

Device: NMES

Interventions

NMES DEVICE

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

NMES; NMES plus protein supplementation

Protein DIETARY_SUPPLEMENT

Participants will consume a daily protein supplement

NMES plus protein supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Motor complete spinal cord injury
• Time since injury injury \>1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• Loughborough University: lead
• McMaster University: collaborator
• Danone Nutricia: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE113TU, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Proteins

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As no placebo supplement is being used in this intervention, it is not possible to do any form of masking.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Applied Disability Sport Director of the Peter Harrison Centre for Disability Sport

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 22, 2022
• Study Start: April 5, 2022
• Primary Completion: January 20, 2024
• Study Completion: February 15, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

GB (1)