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| Name | Class |
|---|---|
| McMaster University | OTHER |
| Danone Nutricia | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| NMES | Active Comparator | Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMES | Device | Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loughborough University | Loughborough | Leicestershire | LE113TU | United Kingdom |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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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.
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As no placebo supplement is being used in this intervention, it is not possible to do any form of masking.
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| Protein | Dietary Supplement | Participants will consume a daily protein supplement |
|
| 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 |
| 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 |
| D014947 | Wounds and Injuries |