EAL

SCI: Lipid Abnormalities (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To investigate a group of spinal cord injured (SCI) premenopausal women with different injury levels (tetraplegics and paraplegics) in comparison with nondisabled controls regarding the lipoprotein profile.

Inclusion Criteria:

Not described

Exclusion Criteria:

Not described

Description of Study Protocol:

Recruitment

Not described by the author.

Design

Controls and participants were measured for weight and height. Blood was drawn to assess lipid profile. The SCI participants underwent a graded exercise test to the point of subjective physical exhaustion. The controls used a bicycle ergometer.

Blinding used (if applicable)

N/A

Intervention (if applicable)

Spinal cord injured subjects underwent a graded exercise test to the point of subjective exhaustion on a wheelchair ergometer (WCE), the control subjects on a bicycle ergometer (BC). Oxygen uptake (VO₂) was continuously measured with an open-circuit spirometry.

Statistical Analysis

Average values and standard deviations (SD) were calculated. The groups were compared by means of the nonparametric Mann-Whitney U test corrected for multiple tesing. P values < 0.05 were considered statistically significant.

Data Collection Summary:

Timing of Measurements

Weight, height and blood was measured at baseline. VO_2max was assessed via exercise testing at baseline.

Dependent Variables

Weight
Height
VO_2max
Serum cholesterol (TC) mg/dL
Triglycerides (TG) mg/dL
LDL-cholesterol (LDL-c) mg/dL
HDL-cholesterol (HDL-c) mg/dL
VLDL-cholesterol (VLDL-c) mg/dL
Liprotein(a) [Lp(a)] mg/dL

Independent Variables

Tetraplegia(TP)
Paraplegia (PP)

Control Variables

None noted by author

Description of Actual Data Sample:

Initial N:

32 Caucasian women, (8 tetraplegics [(TP), 24 paraplegics (PP)].
36 aged-matched, nondisabled Caucasian female controls.

Attrition (final N):

Same as initial

Age:

Tetraplegics (TP) 32.7±7.3 years

Paraplegics (PP) 29.0±5.9 years

Controls (CP)

Ethnicity: Caucasian

Other relevant demographics:

Weight (kg):

TP: 55.0±7.8
PP: 57.3±9.7
CP: 60.0±6.7

Height (cm):

TP: 172.0±5.7
PP: 165.5±10.8
CP: 168.6±6.3

Duration of injury (years):

TP: 11.4±6.9
PP: 10.3±7.1

VO2max:

TP: 19.8±9.2^a,b
PP: 27.0±10.6^b,c
CP: 49.2±7.8^a,c

^aSignificantly different from PP

^bSignificantly different from CP

^cSignificantly differnet from TP

Anthropometrics

TP showed a significanlty lower VO_2max than paraplegics. CP reached a higher VO_2max than PP.

Location: Not described

Summary of Results:

Variables	TP mean±SD	PP mean±SD	CP mean±SD
VO_2max	19.8±9.2^a,b	27.0±10.6^b,c	49.2±7.8^a,c
TG	131.5±69.5^a,b	95.5±37.9^c	74.3±30.1^c
TC	180.7±24.3	207.6±51.4	202.6±30.0
HDL-c	58.7±12.1	59.9±12.3	66.1±14.8
LDL-c	101.2±13.6^a	133.1±43.5^a,c	98.9±20.2^b
VLDL-c	19.8±13.6	16.1±6.6	15.9±4.7
TC/HDL-c	3.1±0.5	3.5±1.0	3.1±1.1
Lp(a)	3.1±3.3	5.8±9.1	6.2±7.3

^a Significantly different from PP

^b Significantly different from CP

^c Significantly different from TP

Other Findings

Author Conclusion:

With the exception of higher TG concentrations in tetraplegics and higher LDL-c levels in paraplegics, lipoprotein levels in female subjects with SCI were comparable with nondisabled controls in spite of the reduced physical performance capacity and sympathetic impairment. No significant differences of Lp(a) were found between female SCI subjects with different injury levels and controls. It can be speculated that premenopausal female spinal cord-injured persons are partly protected from an adverse lipoprotein profile by their hormonal profile.The higher TG levels seen in tetraplegics and the higher LDL cholesterol levels in paraplegics should be considered in the cardiovacular follow-up of female patients with spinal cord injury.

Funding Source:

Government:

Federal Institute of Sports Science, Cologne (Germany)

Not-for-profit

Foundation associated with industry:

Reviewer Comments:

Dietary intake was not described.
Medications were not described.
Inclusion/exclusion criteria were not defined, other health problems if present were not addressed.
Can not apply this study across ethnicities

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		???
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	No
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	???
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		???
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	???
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	???
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	Yes
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	Yes
5.	Was blinding used to prevent introduction of bias?		???
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	???
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	???
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	Yes
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		???
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	???
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	N/A
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	Yes
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	???
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		???
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	???
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes