Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NMES
Protein
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Cord Injuries focused on measuring Protein, NMES
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
Sites / Locations
- Loughborough UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NMES plus protein supplementation
NMES
Arm Description
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps in addition to a daily protein supplement.
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.
Outcomes
Primary Outcome Measures
Change in bone mineral density
Dual x-ray absorptiometry
Change in lean soft tissue mass
Dual x-ray absorptiometry
Change in fat mass
Dual x-ray absorptiometry
Secondary Outcome Measures
Change in glucose tolerance
Oral glucose tolerance test
Change in insulin resistance
Oral glucose tolerance test
Change in fasting plasma lipid concentrations
Resting blood sample
Change in fasting circulating C-reactive protein
Resting blood sample
Change in sacral skin blood flow
Doppler flowmetry
Change in resting metabolic rate
Expired air analysis
Full Information
NCT ID
NCT05249985
First Posted
January 27, 2022
Last Updated
April 6, 2022
Sponsor
Loughborough University
Collaborators
McMaster University, Danone Nutricia
1. Study Identification
Unique Protocol Identification Number
NCT05249985
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
McMaster University, Danone Nutricia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Protein, NMES
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
As no placebo supplement is being used in this intervention, it is not possible to do any form of masking.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NMES plus protein supplementation
Arm Type
Experimental
Arm Description
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps in addition to a daily protein supplement.
Arm Title
NMES
Arm Type
Active Comparator
Arm Description
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.
Intervention Type
Device
Intervention Name(s)
NMES
Intervention Description
Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Intervention Description
Participants will consume a daily protein supplement
Primary Outcome Measure Information:
Title
Change in bone mineral density
Description
Dual x-ray absorptiometry
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in lean soft tissue mass
Description
Dual x-ray absorptiometry
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in fat mass
Description
Dual x-ray absorptiometry
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Secondary Outcome Measure Information:
Title
Change in glucose tolerance
Description
Oral glucose tolerance test
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in insulin resistance
Description
Oral glucose tolerance test
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in fasting plasma lipid concentrations
Description
Resting blood sample
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in fasting circulating C-reactive protein
Description
Resting blood sample
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in sacral skin blood flow
Description
Doppler flowmetry
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in resting metabolic rate
Description
Expired air analysis
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Other Pre-specified Outcome Measures:
Title
Change in blood pressure
Description
Automatic blood pressure cuff
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in daily energy intake
Description
3 day food diary
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in physical activity
Description
Wrist-worn accelerometer
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in physical activity
Description
Leisure time physical activity questionnaire
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in sleep efficiency and duration
Description
Wrist-worn accelerometer
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in sleep quality
Description
Sleep Quality Scale (available answers include: rarely, sometimes, often, almost always)
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in muscle spasticity
Description
The Spinal Cord Injury Spasticity Evaluation Tool
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in mental health
Description
5-item Mental Health Inventory
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in neuropathic pain
Description
Neuropathic Pain Questionnaire
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in body image
Description
Body Image Satisfaction Questionnaire
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in skinfold thickness
Description
Measured in millimetre
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Height
Description
Measured in meters
Time Frame
Pre-intervention only
Title
Change in waist and hip circumference
Description
Measured in centimeters to provide a waist-to-hip ratio
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
Title
Change in body weight
Description
Measured in kilograms
Time Frame
Pre-intervention (baseline) and at 1 week post-12 week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan M Fenton, PhD
Phone
+44(0)7903033288
Email
J.Fenton@lboro.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Vicky Tolfrey, Prof
Phone
+44(0)1509226386
Email
v.l.tolfrey@lboro.ac.uk
Facility Information:
Facility Name
Loughborough University
City
Loughborough
State/Province
Leicestershire
ZIP/Postal Code
LE113TU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan M Fenton
Phone
+447903033288
Email
J.Fenton@lboro.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI
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