Clinical trial NCT03661294: Investigating the Energy Expenditure of Acute Spinal Cord Injured Patients
Official title: Feasibility Study to Investigate the Energy Expenditure of Acute Spinal Cord Injured Patients at Different Stages of Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury, Acute
Keywords: Energy, spinal cord injury
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Nutricia UK Ltd
name: University of Sheffield
First posted: 2018-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: It is recognised that weight gain is a common problem in patients with a spinal cord injury and can lead to an increased incidence of metabolic syndrome. Weight gain is thought to be attributed to excess calorie intake, reduction in energy requirements and / or a reduction in exercise. However, further understanding of this energy imbalance needs to be addressed.

This feasibility study will initially determine if it is feasible to measure the 'actual' energy requirements of 15 paraplegic and 15 tetraplegic (ventilated and non-ventilated) in-patients during bed rest and rehabilitation following acute SCI. This preliminary data will be compared to 'predicted' energy expenditure levels. The calorie intake and body composition for each patient will be measured as well as factors indicative of metabolic syndrome. The study will initially provide statistical information in order to estimate the sample size required for a future definitive study.

Detailed description: Introduction:

There are an estimated 40,000 people living with a Spinal Cord Injury (SCI) in the UK alone (http://www.apparelyzed.com/statistics.html). Although there have been improvements in medical care, mortality rates are still elevated compared to the able-bodied population. The most common underlying and contributing causes of death in SCI patients are diseases of the circulatory and respiratory system.

It is recognised that weight gain is a common problem in patients with a SCI, typically occurring within the first year of rehabilitation and continuing life long. SCI patients have been shown to have an increased fat mass, waist circumference and altered lipid profile. Obesity in SCI patients can lead to an increased incidence of metabolic syndrome.

Patient weight gain is thought to be attributed to the reduction in energy expenditure compared to pre-injury levels, the loss of voluntary muscle use below the spinal cord lesion and reduction in lean tissue mass. It has been shown that the basal metabolic rate (BMR) of SCI patients is lower than predicted, with the greatest difference being for high tetraplegics. Findings suggest there is an overestimation of energy requirements in a small population of medically stable SCI patients. In addition, SCI calorie and protein intake is high in this patient population, suggesting that patients are also exceeding their nutritional recommendations. Excess calorie intake, reduction in energy requirement and / or a reduction in exercise will predispose the SCI patient to weight gain and obesity. Further understanding of this energy imbalance needs to be addressed.

This single centre feasibility study will initially determine if it is feasible to measure the 'actual' energy requirements of paraplegic and tetraplegic (ventilated and non-ventilated) in-patients during bed rest and rehabilitation following acute SCI. This preliminary data will be compared to 'predicted' energy expenditure levels. The calorie intake and body composition for each patient will be measured as well as factors indicative of metabolic syndrome. The study will initially provide statistical information in order to estimate the sample size required for a future definitive study on energy expenditure and development of metabolic syndrome in SCI patients. In addition, the feasibility study will address patient recruitment rates and reasons for withdrawal from the study and highlight any practicality issues with study conduct.

Recruitment:

15 acute paraplegic and 15 acute tetraplegic (ventilated and non-ventilated) inpatients will recruited.

Methodology:

The following procedures will be performed at bed rest, early mobilisation and hospital discharge:

Measurement of Actual Energy Expenditure Actual resting energy expenditure (REE) is determined by measuring the oxygen consumption and carbon dioxide production of a patient at rest using the GE Healthcare metabolic oxygenator. During the test, the individual is interfaced with a metabolic measurement system by means of a facemask. For ventilated patients, the monitor will be used with a cuffed tracheostomy tube.

Software will be used to calculate the respiratory quotient (RQ).

Calculating Predicted Energy Requirements Henry equations are used to predict the basal metabolic rate. Adjustments are made based on metabolic stress associated with illness and for obese individuals.

Determining Dietary Intake The patient's dietary intake will be reported using the standard hospital food charts. These will be completed for all food and fluids taken providing an indication of portion sizes. The charts will be kept for 3 consecutive days at each time point and is based on a pragmatic approach to improve accuracy of completion over a short period of time whilst still providing daily variations in intake. Data will be collected so that it covers at least one day of a weekend.

Anthropometric Measurements

Anthropometric measurements will be taken to determine patient body fat and muscle. The following parameters will be measured:

1. Mid Upper Arm Circumference (MUAC)
2. Tricep Skinfold Thickness (TSF)

Mid Arm Muscle Circumference (MAMC) will be calculated using the equation:

MAMC = MUAC - 3.14 x TSF

Metabolic Syndrome Measurements

The following will be measured:

1. Weight
2. Height
3. BMI Calculation
4. Blood Pressure
5. Waist Circumference
6. Fasting glucose, HDL, triglycerides

Eligibility criteria: Inclusion Criteria:

* Aged 18+ years old inclusive
* Traumatic and non-traumatic tetraplegic or paraplegic patient following acute SCI injury
* First referral to the Sheffield Spinal Injuries Centre
* Pressure ulcer(s) category 1 and/or 2 or normal skin
* Be able to provide written informed consent or verbal consent in the presence of an independent witness
* Ventilated patients without sedation
* Enterally fed patients

Exclusion Criteria:

* Aged less than 18 years old
* Lack the mental capacity to consent
* Pressure ulcer(s) category 3 and/or 4
* Previously had or currently have metabolic syndrome
* Previously had or currently have diabetes
* Current medication includes either a stimulant(s) and/or depressant(s) e.g. steroids, anti-depressants
* MRSA bacterium positive
* Previously had or currently has an eating disorder
* Ventilated patients with sedation
* Currently participating in another research study which may have an impact on the study or patient safety and well-being.

Primary outcomes:
measure: Sample size for definitive study
timeFrame: 1 year
Secondary outcomes:
measure: Recruitment Period for Definitive Study
timeFrame: 1 year
measure: Predicted Energy Requirements
timeFrame: 1 year
measure: Dietary Intake
timeFrame: 1 year
measure: Muscle Measurements
timeFrame: 1 year
measure: Adipose Tissue Measurements
timeFrame: 1 year
measure: Lipid Measurements
timeFrame: 1 year
measure: BMI Measurements
timeFrame: 1 year
measure: Blood Pressure Measurements
timeFrame: 1 year
measure: Glucose Measurements
timeFrame: 1 year
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
References: