EAL

SCI: Lipid Abnormalities (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To highlight the effects of a constant level of long-term strenuous exercise on lipid markers in a 41-year-old male with paraplegia and to demonstrate the feasibility, practicality, and quantitative value of incorporating long-term strenuous exercise into a paraplegic individual's lifestyle.

Inclusion Criteria:

Not noted by author

Exclusion Criteria:

Not noted by author

Description of Study Protocol:

Recruitment

Not described

Design

The subject engaged in a swimming exercise regimen that increased from one hour per week (840 kcal) to 3.5 hours per week (2940 Kcal). Weight, Heart rate, and lipid profile was measured at baseline, 3, 6, 9, 12, 24, 36, 48, 60 and 72 months.

Blinding used (if applicable)

N/A

Intervention (if applicable)

The subject engaged in a swimming exercise regimen that increased from one hour per week (840 kcal) to 3.5 hours per week (2940 Kcal).

Statistical Analysis

Not described

Data Collection Summary:

Timing of Measurements

Heart rate was monitored throughout the swimming sessions.

Lipid profiles and weight were assessed at baseline and every three months for one year then yearly for a total of 72 months.

Dependent Variables

Heart rate (beats/minute)
Total cholesterol (TC) mg/dL
HDL- cholesterol (HDL-c) mg/dL
Triglycerides (TG) mg/dL
LDL-cholesterol (LDL-c) mg/dL
Weight (kg)
Dietary intake analyzed using the CBord system.

Independent Variables

Paraplegia
Exercise program (at 1 hour/week - 840 kcal to 3.5 hours/week-2940 kcal).

Control Variables

None noted by author

Description of Actual Data Sample:

Initial N: One

Attrition (final N): One

Age: 41 years old

Ethnicity: Caucasian

Other relevant demographics: Paraplegic; with control of both quadriceps and adductor muscle groups in the upper legs.

Anthropometrics N/A

Location: Not decribed

Summary of Results:

Lipids and weight measurements over the 72 onths of the study

Variables	0	3	6	12	24	36	48	60	72
TC (mg/dL)	174	165	165	151	173	185	192	182	196
LDL-c (mg/dL)	131	116	116	95	114	129	130	124	130
HDL-c (mg/dL)	25	30	33	31	43	44	43	48	46
TG (mg/dL)	92	93	78	126	79	62	90	70	101
Weight (kg)	75	72	68	67	67	67	68	69	70

Other Findings

The 1 kg weight gain noted in the last 3 years reflects a mild caloric increase in the diet. During the first 12 months of the study, a conscious attempt was made to reduce saturated fats.

Author Conclusion:

Long-term strenuous exercise in a paraplegic is an important independent variable that can significantly elevate the abnormally low HDL-c level found in individuals with paraplegia. There was a slow, continuous increase in HDL-c with time. The energy cost (equivalent) for each additional 1 mg/dL HDL-c has been calculated at 100 kcal/week.

Funding Source:

Reviewer Comments:

The exercise level was well controlled and constant throughout the months of study.
This case study may help to document the effect of long-term exercise in elevating HDL-c.
It was not obvious who measured the subject's heart rate and weight throughout the 72 months.
May be difficult to repeat this study with larger numbers of subjects due to the inherent difficulties in a very long-term, multi-individual exercise study.

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?	???
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?	N/A
	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?	Yes
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")?	Yes
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?		???
	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.)	???
	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?	Yes
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?	???
	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?	Yes
	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?	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?	???
	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?		???
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	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?	No
	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?	No
	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