SCI: Caloric and Protein Needs in Acute and Rehabilitation Phases (2007)
Recruitment
Flyers and pamphlets sent to several organizations (Toronto Rehabilitation Institute, Ontario Wheelchair Sports Association, Canadian Paraplegic Association, Spina Bifida and Hydrocephalus Association of Toronto)
Design
Cross-sectional study. Comparison, by lesion (complete or incomplete) and by sex, of body composition, energy expenditure and energy intake of free living individuals with paraplegia at one point in time.
Blinding used (if applicable)
Not applicable.
Intervention (if applicable)
None.
Statistical Analysis
- paired Student's t test (FLEX and 3-MET)
- Bland and Altman analysis (FLEX and 3-MET)
- x2 (differences in obesity; sex distribution between the two groups)
- Pearson's partial correlation squared (association between years since onset of injury and % FM, TDEE, PAL)
- Mann-Whitney two-tailed U test (differences between dicotomous variables)
- Mann-Whitney one-tailed U test (comparison of subjects with complete vs incomplete lesions)
- ANCOVA (differences in TDEE between groups)
Timing of Measurements:
One time only. Studies carried out during a half-day visit.
Dependent Variables
- Resting metabolic rate (RMR) (open circuit indirect calorimetry, 2900 Energy Expenditure Unit, Sensormedic)
- Total daily energy expenditure (TDEE) (heart rate monitoring for 3 nonconsecutive days with a Polar HRM; FLEX method, in which heart rate rest is distinguished from heart rate exercise)
- PAL (calculated: TDEE/RMR)
- Total body water (deuterium dilution)
- Fat-free mass (calculated: FFM = total body water/0.732)
- Fat mass (calculated: FM = weight minus FFM)
Independent Variables
- Paraplegic lesion (complete/incomplete)
Control Variables
- Obesity (defined based on FM, age and sex).
- structured physical activity (unstructured activity records while wearing heart rate monitor)
- Energy intake (3-day food records, Fuel Nutrition Software v 2.1a.1, Logiform, Quebec, CA)
Initial N: 30 subjects recruited.
Attrition (final N): 27 (17 men, 10 women), 17 with complete lesions and 10 with incomplete lesions. 3 were dropped - 1 became acutely ill, 1 refused to wear the heart rate monitor and the heart rate monitor malfunctioned in the third subject.
Age: Men, 38 years (range 22-57); Women, 32 years (range 24-41)
Ethnicity: not reported
Other relevant demographics: years since onset of paraplegia: Men, 10.4 (range 1.5=29); Women, 16.1 (range 2.8-39)
Anthropometrics
- Height (cm±sd): Men, 173± 7.1; Women, 154±10.6 (p<0.001)
- Weight (kg±sd): Men, 71.2±14.6; Women, 57.5±14.2 (p= 0.0175)
Location: The Hospital for Sick Children, Toronto, Canada
Table 1: Energy expenditure in men and women with paraplegia
Variables |
Men (n=17) (mean±sd) |
Women (n = 10) (mean±sd) |
p value |
RMR (kcal/d) |
1555±165 | 1245±176 | p=0.0011 |
TDEE (kcal/d) |
2490±637 |
1870±607 |
p=0.0203 |
PAL |
1.60±0.33 |
1.49±0.36 |
NS |
Energy intake (kcal/d by 3 day food record) | 2112±572 | 1596±418 | p=0.0227 |
*PAL as defined by WHO (2000): 1.4 = sedentary; 1.55-1.6 = limited; > or equal to 1.75 is physically active.
Table 2: Body composition and energy expenditure based on lesion (complete = absence of sensory and/or motor function below level of lesion; incomplete = partial sensory and/or motor function below level of lesion and sensory/motor function in the S4 to S5 sacral segments)
Variables
|
Complete lesion (n = 17) (mean±sd) |
Incomplete lesion (n = 10) (mean±sd) |
p value (significance <0.05) |
Height (cm) | 164±13.4 | 170±9.9 | NS |
Weight (kg) | 65.5±15.2 | 67.3±17.3 | NS |
FFM (% body weight) | 65.0±9.0 | 72.2±9.1 | NS |
FM (% body weight) | 35.0±9.0 | 27.8±9.1 | NS |
RMR (kcal/d) | 1417±214 | 1480±249 | NS |
TDEE (kcal/d) | 2072±505 | 2582±852 | p=0.0372 |
PAL | 1.46±0.25 | 1.72±0.41 | NS |
Other Findings
19 subjects (13 men, 6 women) were classified as obese using the following definitions: men 18-40 yrs >22% FM and 41-60 yrs >25% FM; women 18-40 yrs > 35% FM and 41-60 yrs > 38% FM.
15 subjects engaged in structured activity during the observation period (at least 2 days), with a mean of 49.4±31 min/session.
Energy intakes (by 3-day food records) were underreported by a mean of 340±781 kcal/day (underreporting defined as EI/TDEE<0.79)
There was no significant difference between TDEE determined by FLEX vs 3-MET methods (2261± 686 vs 2165±565 kcal/d)
PALs in this sample of free-living men and women with chronic paraplegia are lower than those recommended by the WHO, which may explain the high incidence of obesity.
Persons with paraplegia need to engage in increased frequency, duration, and/or intensity of physical activity to achieve a PAL greater than or equal to 1.75.
TDEE is significantly lower in persons with complete vs incomplete lesions.
Strengths of this study include the detailed description of methodology, assessment of free-living subjects, and the inclusion of women.
Since WHO rather than IOM PALs were used, some calculation may be needed before comparison with American data.
Quality Criteria Checklist: Primary Research
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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) | ??? | |
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? | ??? | |
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.) | No | |
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? | Yes | |
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? | No | |
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.) | N/A | |
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? | Yes | |
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? | Yes | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | Yes | |
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? | N/A | |
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? | 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? | 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 | |