To develop a prediction equation to validly estimate the body composition of people with a SCI using bioelectrical impedance analysis (BIA)To develop a prediction equation to validly estimate the resting energy expenditure of people with a SCI from…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body composition measured by DXA, Bod Pod, and BIA. DXA and Bod Pod will be
used as gold standard to determine fat mass, fat percentage and fat free mass,
while the outcomes of BIA will be used to compare with the standard and develop
a new formula to predict the fat free mass in people with SCI.
Resting energy expenditure in Kcal/day measured by indirect calorimetry. Fat
mass and fat free mass will be included in developing predictive REE formulas
for SCI populations.
Primary outcome measures:
- resting energy expenditure in Kcal/day
- Fat mass (kg)
- Fat free mass (kg)
Secondary outcome
Anthropometrics: body mass (kg), height (cm), Bodymass index (BMI), waist
circumference (cm), Fat free mass (kg and %), fat mass (kg and %).
Gender, age, lesion level and motor completeness, time since injury,
educational level, present co-morbidities, alcohol consumption, smoking habits
and ethnicity.
Background summary
A lower level of resting energy expenditure (REE) comparing with the
able-bodied people is a big challenge among spinal cord injury (SCI) patients.
With metabolic and physiologic changes combined with physical inactivity, SCI
population is more likely to experience positive energy balance during daily
life which will naturally increase the risk of obesity. Obesity is regarded as
the most common secondary complication, affects SCI patients* health and is
associated with many adverse metabolic. The clinical consequences along with
decreased physical activity as well as unbalance diets all contribute to the
negative changes of body composition and metabolic profiles in people with SCI.
Thus, to investigate the prediction equation of energy expenditure and body
composition in SCI individuals is clearly warranted.
During daily life, REE comprises the greatest proportion (~70%) of total daily
energy expenditure in healthy people and even up to 80% of those sedentary
populations. Considering the limited mobility and sedentary lifestyle, REE
should be paid much attention in people with SCI in order to control their
energy balance and help them to maintain health. In general, body weight and
height are often used for the prediction of REE in health people, but this
seems not a reliable way to estimate the situation in SCI patients. The reason
of this may explained by the changes in body composition and sympathetic
nervous system activity. Fat free mass (FFM) is regards as the most important
and valuable predictor of REE in both healthy and SCI population. This may due
to the numerous high-energy cost processes which occur in organs and muscles.
Good management of REE and obesity in people with SCI is really important for
their health and quality of life. However, to measure REE, expensive devices
are needed and therefore not accessible for large groups. According to the
strong correlation between FFM and REE in people with SCI, it seems feasible to
add FFM into the equation as well as personal and other characteristics for
predicting REE of SCI individuals. To accurately determine the body composition
of individuals with spinal cord injury, a new equation model specified on this
population should be developed. Bioelectrical impedance analysis (BIA) is an
alternative method of dual-energy X-ray absorptiometry (DEXA) scan in measuring
body composition which is more practical and convenient with relatively
reliable results. An equation model based on Bio-impedance analysis should be
developed.
Study objective
To develop a prediction equation to validly estimate the body composition of
people with a SCI using bioelectrical impedance analysis (BIA)
To develop a prediction equation to validly estimate the resting energy
expenditure of people with a SCI from personal and lesion characteristics and
body composition.
Study design
A cross-sectional study will be performed to determine body composition and
REE. During one-time visit for 100 individuals with SCI, DXA and Bod Pod will
be used as gold standard to determine the body composition. The reactance and
resistance outcomes from the BIA together with the personal and lesion
characteristics, will be used to develop a new formula to predict the fat free
mass in people with SCI. Anthropometrics will also take place.
REE will be determined by indirect calorimetry. A multiple linear regression
analysis will be performed to develop predictive REE formulas for SCI
populations. Age, gender, time since injury, level of injury (paraplegia or
tetraplegia), motor completeness, fat mass, fat free mass will be included as
possible predictors in the SCI population.
Study burden and risks
The total burden and risks in participating in this study are low. Although the
study population is more fragile, no real burdens are put in the participants.
The study consists of 1 visit if approximately 2 hours where personal and
lesion characteristics are collected.
The anthropometric measurements are low in burden, since all measurements are
collected passively in either upright sitting position or supine position.
The radiation during a DXA scan are negligible. The radiation of one full body
scan is less than half the amount of radiation exposed to surrounding
radiation.
All participants will receive a personal report afterwards with outcomes of the
body composition and energy expenditure. This can be considered as valuable
information, especially for these populations.
Van der Boechorststraat 7
Amsterdam 1081BT
NL
Van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 75 years
- Complete or incomplete SCI at or below C5 (i.e. not on a ventilator)
- Chronic (>1 year) SCI
Exclusion criteria
- Presence of metabolic syndrome
- Pregnant
- Presence of menstruation period at day of measurement
- Recent presence (<1 month) of any infection such as urinary or respiratory tract infections
- Presence of a pacemaker
- Presence of pressure ulcers
- insufficient knowledge of the Dutch language to understand the content of the study and questionnaires
- Presence of progressive illness
- Presence of psychiatric disorders
- Presence of edema
- Presence of fever (>39 degrees)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL64704.048.18 |