- The main objective of this study is to develop a predictive model that can estimate the rest energy expenditure in indviduals with SCI or LLA.- To develop a model based on raw accelerometry data that can estimate the energy expenditure during ADL…
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
traumatische en niet traumatische onderste extremiteit amputaties
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Rest energy expenditure in kcal/day
- activity energy expenditure during ADL activities and strength activities
- Accelerometry data. All raw accelerometry measured during ADL activities and
strength activities
Secondary outcome
personal information: gender, age, lesion/amputation characteristics, time
since injury, type and amount of sport/week, educational level, comorbidities,
alcohol consumption, smoke behaviour, ethnicity.
Anthropometrics: Weight (kg), Height (m), BMI, waist circumference (cm), Fat
free mass (kg and %), fat mass (kg and %)
Activity level: PASIPD questionnaire score
Perceived exertion during strength exercise block: RPE score
Heartrate during rest and activity: Hartbeats / min.
Training impulse score (TRIMP)
If the measurement takes place in Amsterdam the participants with SCI will also
be asked to participate in study 1806. If the participant agree on this,
additional measurements will be done with the DXA scan, BodPod and InBody S10
BIA device to measure fat mass and fat free mass in kilo's and %. The InBody
S10 will also give results on reactance and resistance.
Background summary
Obesity and inactivity is a common problem in current society. Especially in
individuals with a spinal cord injury or lower limb amputation. The activity
levels of these specific populations is sometimes as little as 40% compared to
able bodied individuals. Because of physiological changes due to a spinal cord
injury the rest energy expenditure can drastically decline. Resting energy
expenditure is responsible for the largest part of the total daily energy
expenditure. In some cases the resting energy expenditure is as little as 50%
compared to able bodied individuals. In individuals with lower limb amputation
very little is known about the effect of amputation on their resting energy
expenditure.
The reduction in resting energy expenditure and the inactivity makes obesity a
big problem in these populations. In order to tacle obesity, a balance between
energy intake and energy expenditure is needed. However, it is very difficult
to determine rest energy expenditure and activity energy expenditure in these
individuals because of the physiological changes. To measure (rest) energy
expenditure expensive devices are needed and therefore not accessible for large
groups. A solution for this problem would be a predictive model that takes
personal and lesion characteristics into accoount to estimate (rest) energy
expenditure. Therefore new predictive models should be developed to accurately
estimate resting energy expenditure en activity related energy expenditure in
these populations.
Study objective
- The main objective of this study is to develop a predictive model that can
estimate the rest energy expenditure in indviduals with SCI or LLA.
- To develop a model based on raw accelerometry data that can estimate the
energy expenditure during ADL activities and during strength exercise.
Study design
Cross-sectional observational study to develope predictive models on rest
energy expenditure and activity energy expenditure.
In total of 40 individuals with SCI will be measured and 40 individuals with
LLA will be measured divided over two locations.
Participants are invited for one visit for measurements where personal and
lesion characteristics are gathered together with energy expenditure by
indirect calormetry during rest, ADL activities and strength activities.
Accelerometry data is also gathered during measurement.
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 of approximately 2,5 hours where personal and
lesion characteristics are collected.
When someone with a SCI participates at the location in Amsterdam, the
individual will be asked to participate with an additional study P1806. If the
individual agrees, an additional 30 minutes will most likely added on the total
time of 2,5 hours, which results in a total time of around 3 hours.
The anthropometric measurements are low in burden, since all measurements are
collected passively in either upright sitting position or supine position.
Most ADL activities are most likely feasible for the participants. When an
activity is physically not possible, this activity will be skipped.
The strength activities are adjusted on the physical capabilities of the
participant, and does not include high intensity maximal exercise.
All participant will receive a personal report afterwards with outcomes of the
findings in energy expenditure. This can be considered as valuable information,
especially for these populations.
Overtoom 283
Amsterdam 1054 HW
NL
Overtoom 283
Amsterdam 1054 HW
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 75 years
- Dependent on a manual wheelchair (daily use of the wheelchair, wheelchair dependent at distances of 500m+)
- In case of a SCI, lesion at or below C5 (not on a ventilator)
- Chronic (>1 year) SCI or LLA
Exclusion criteria
- Severe co-morbidities (Diabetes type II individuals can only be included when sugar levels are in control, between 4.4 and 7.2 mmol/L or below 10.0 mmol/L 2 hours after meal)
- Presence of metabolic syndrome
- Pregnant
- 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 menstruation on the day of measurement
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 | NL64291.048.17 |