SCI: Preventing Overweight (2007)

Study Design:
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Quality Rating:
Research Purpose:

To determine the lipid profiles and the glucose tolerance among rehabilitated paraplegic and tetraplegic persons.

Inclusion Criteria:
  • Adults with paraplegia or tetraplegia.
  • Those with lesions > 1 yr
Exclusion Criteria:

Complications, such as symptomatic urinary tract infection, renal failure and pressure ulcer.

Description of Study Protocol:


138 patients who had been rehabilitated in the facility were invited to return for an annual medical check


Clinical evaluation and biochemical measurements at one point in time

Blinding used (if applicable)




Statistical Analysis

None; however, mean and standard deviations calculated


Data Collection Summary:

Timing of Measurements:


Dependent Variables

  • walking status (walkers were those using orthoses and crutches; non-walkers were those dependent on wheelchairs or tricycles
  • blood pressure
  • Fasting lipid profile (total cholesterol, LDL, HDL, triglycerides) using cholesterol oxidase paraminophenazone techniques
  • Fasting plasma glucose (glucose oxidase peroxidase technique)
  • 2-hr postprandial plasma glucose (after 75 g oral glucose) using the glucose oxidase peroxidase technique
  • serum creatinine, packed cell volume, serum albumin

Independent Variables

  • SCI

Control Variables 

none reported



Description of Actual Data Sample:

Initial N: 48 SCI pts: 43 males and 5 females.

Attrition (final N): not applicable

Age: 16-52 years

Ethnicity: Not mentioned

Other relevant demographics: none

Anthropometrics: none

Location: Christian Medical College Hospital, Vellore, India

Summary of Results:
  • Hypertension was observed in only 6% of the subjects.
  • Fasting hyperglycemia was observed in 19% and glucose intolerance in 23% of the subjects.
  • Total cholesterol was abnormal in 2%, but 58% had low levels of high density lipoprotein (HDL). 10% of the subjects had raised low density lipoprotein (LDL) levels.

Other Findings

  • cervical cord lesions (3); thoracic lesions (28); lumbar cord lesions (17)
  • 27 walkers and 21 non-walkers
  • injury<5 yrs (25); injury 5-10 yrs (14); injury >10 yrs(9)
  • all subjects had normal packed cell volumes, serum albumin, and serum creatinine values
Author Conclusion:

The cardioprotective HDL fraction may remain very low even while the total cholesterol level is within normal limits, and unless lipid profile estimation is done, this group of individuals who are at cardiovascular risk may remain undetected.

Glucose intolerance and dyslipidemias are common among paraplegic and tetraplegics individuals, and these metabolic derangements may contribute to increased cardiovascular morbidity.

Funding Source:
University/Hospital: Christian Medical College Hospital (India)
Reviewer Comments:
  • Small number of subjects.

  • No control group. Comparing the lipid profile and glucose level with persons having similar characteristics (age, activity levels and others), but no SCI, can give us a more convincing conclusions.
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) N/A
  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) N/A
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? No
  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? Yes
  2.2. Were criteria applied equally to all study groups? N/A
  2.3. Were health, demographics, and other characteristics of subjects described? ???
  2.4. Were the subjects/patients a representative sample of the relevant population? No
3. Were study groups comparable? N/A
  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? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  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? N/A
  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.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? N/A
  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? N/A
5. Was blinding used to prevent introduction of bias? N/A
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  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.) N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  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? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? N/A
  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? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? N/A
  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? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
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? ???
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? N/A
  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? ???
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? N/A
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? ???
  8.2. Were correct statistical tests used and assumptions of test not violated? ???
  8.3. Were statistics reported with levels of significance and/or confidence intervals? N/A
  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)? N/A
  8.6. Was clinical significance as well as statistical significance reported? N/A
  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? ???
  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? No
  10.2. Was the study free from apparent conflict of interest? Yes