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SCI: Caloric and Protein Needs in Acute and Rehabilitation Phases (2007)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
To investigate factors that influence resting metabolic rate (RMR) and thermic effect of feeding (TEF) in a group of healthy adult men and women with paraplegia, compared to healthy controls.
Inclusion Criteria:
Healthy men and women with paraplegia; healthy control subjects
Exclusion Criteria:
No history of diabetes, Crohn's disease, renal disease, heart disease, hypothyroidism, hyperthyroidism.
Description of Study Protocol:

Recruitment

  • Paraplegic subjects: Toronto Rehabilitation Institute, Ontario Wheelchair Sports Association, Ontario March of Dimes, Canadian Paraplegic Association, Spina Bifida and Hydrocephalus Association of Toronto
  • Controls: University of Toronto, Ryerson University, staff of The Hospital for Sick Children in Toronto

Design : Comparison of body composition and energy metabolism measures in healthy paraplegic individuals vs able-healthy controls at one point in time. Subjects were group matched on the basis of body mass index.

Blinding used (if applicable)

Not applicable

Intervention (if applicable)

None

Statistical Analysis

  • Power calculation
  • Chi-square analysis (differences in sex distribution between groups)
  • t-test (differences between subgroups - e.g.: male vs male; trauma vs nontrauma)
  • ANOVA with Tukey post hoc test (differences between controls, paras with complete lesions and paras with incomplete lesions)
  • Pearson's product-moment correlation coefficients (quantification of univariate associations between fat free mass (FFM) and selected variables and RMR and selected variables
  • Analysis of covariance (adjustment of indexes of energy metabolism for selected predictor variables)
Data Collection Summary:

Timing of Measurements

 One time only

Dependent Variables

  • RMR: continuous open-circuit indirect calorimetry (2900 Energy Expenditure Unit)
  • TEF: indirect calorimetry (as above; for 120 min after consumption of a mixed liquid meal)
  • Total body water (TBW): deuterium dilution
  • Extracellular water: corrected bromide space
  • FFM: calculated by TBW/0.732
  • BCM: calculated [(TBW-extracellular water)/0.732] 

Independent Variables

  • paraplegia

Control Variables

  • Thermogenic hormones:TSH (sandwich magnetic separation immunoassay); T3 and free T4 (competitive magnetic separation immunoassay); metanephrine (LC-4C BAS Amperometric detector, Bioanalytical Systems Inc).
Description of Actual Data Sample:

Initial N: 34 control men and women; 32 paraplegic men and women

Attrition (final N): 34 controls (23 men, 10 women); 28 paraplegic subjects (17 men, 11 women) 

Age: control mean age:29.1±7.6 y; paraplegic mean age:33.9±9.2 y (p=0.0229)

Ethnicity: not reported

Other relevant demographics: none mentioned

Anthropometrics: (see results table)

Location: The Hospital for Sick Children, Toronto, Canada

 

Summary of Results:

 

Variables

Paraplegia group (n= 28) mean±SD                

 

Control group (n= 34) mean±SD

 

P value, difference between groups

Weight (kg)

 65.6±16.3 (range 42.9-100)

70.7±10.6 (range 50.2-98.0) 

NS
Height (cm)

 164.5±13.0 (range 138-183)

 173.±10.2 (range 151-202)

 p=0.0052
FFM (% body wt) 69.2±8.7 77.2±7.2 p=0.0002
Body cell mass (% body wt) 35.9±8.1 47.4±6.7 p<0.0001

Measured RMR (kj/d) (kcal/d)

 

6159±954 (1471±228)

 

 

 7016±935 (1676±223) p=0.0007
RMR adjusted for FFM (kj/d)(kcal/d 6588±501 (1574±120) 6670±504 (1593±120) NS
TEF (% test energy intake) 5.53±1.8 6.25±2.2 NS

Other Findings

1. There were no significant differences between the control and paraplegic groups in any of the thermogenic hormones measured

2.  There were no significant differences in any of the parameters between subjects whose paraplegia was caused by trauma (n=16) and those whose paraplegia was not (n= 12)

Author Conclusion:

1. FFM, BCM, and RMR, but not obligatory TEF, are lower in paraplegic than in control subjects

2. RMR does not differ between control and paraplegic subjects after adjustment for FFM, indicating similar metabolic activity in the fat-free compartment of the body

Funding Source:
Not-for-profit
0
Foundation associated with industry:
Reviewer Comments:

1. Because of limitation in measurement time, TEF was only measured for 2 hrs, which captured the obligatory but not the facultative phase of TEF.

2.  Prediction equations may be of limited generalizability, and results do not apply to quadraplegics.

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) ???
  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) ???
 
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? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? Yes
  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.) 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? Yes
  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.) Yes
  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? 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%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  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? No
  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.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? No
  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? ???
  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? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? ???
  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? Yes
  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? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  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? Yes
  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)? Yes
  8.6. Was clinical significance as well as statistical significance reported? ???
  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? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
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