EAL

CKD: Physical Activity (2008)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of this study was to assess the effects of early rehabilitation of the locomotor system in real allograft recipients, using monitoring of blood concentrations of selected atherosclerosis markers.

Inclusion Criteria:

Adult patients (both men and women) were recruited within two to three days after renal transplant for this study
All patients gave written informed consent.

Exclusion Criteria:

Patients were excluded if they had:

Medical complications that prevented regular participation
Acute rejection of the renal transplant
A previous history of coronary artery disease
Diabetes
Abnormal liver function tests
Active infection
Active cancer
Unwillingness to participate in program.

Description of Study Protocol:

Recruitment: Recruited by study staff within two or three days after renal transplant.
Design: After a baseline assessment, patients were randomly assigned to two groups: The physical exercise intervention group (PT) and the standard care controls (CT)
Intervention: The PT group trained every other day for 30 minutes per session, assisted by a a physiotherapist. On alternate days, they repeated the exercise program on their own (during hospital stay, after transplant).

Statistical Analysis

Paired and unpaired Student's T-tests were used
Pearson or Spearman correlations were used to determine associations between variables of interest and the tested parameters
Statistical significance was set at P<0.05.

Data Collection Summary:

Timing of Measurements

At the beginning of the study and four to five weeks post-transplantation, laboratory day was measured
The PT group had additional testing that evaluated respiratory and circulatory systems (BP, EKG, PEF measurements)
Participants were also followed at six months and 12 months, yet it states that "data was not included."

Dependent Variables

Serum concentrations of selected atherosclerosis markers:

Total-homocysteine (t-Hcy) and interleukin-18 (IL-18)
Total cholesterol (Ch-t), triglycerides, low-density lipoprotein cholesterol (LDL) and high-density lipoprotein cholesterol (HDL)
Creatinine, glucose, electrolytes, calcium, phosphorus, ALT, aspartate aminotransferase, B₁₂, folate, albumin, hemoglobin, fibrinogen.

Independent Variables

Exercise training led by physiotherapist every other hospital day.

Description of Actual Data Sample:

Initial N

69 patients

42 males and 27 females, as stated in Table One and the first paragraph of Results
37 males and 32 females, as stated in the first paragraph of Patients and Methods.

Attrition (Final N)

Attrition is not addressed, but it is implied that there was no attrition.

Age

Mean age: 45.5±9 years
PT group: 43.75±12.2 years
Control group: 46.11±12.3 years.

Ethnicity

Not discussed, yet study took place in Warsaw, Poland, so we assume that they were mostly Polish.

Other Relevant Demographics

60% of PT group were smokers, while 38% of the control group were smokers.

Anthropometrics

The control group had a significantly higher BMI than this PT group

Control: 28.78±5.5kg per m²
PT group: 23.87±2.6kg per m²
P<0.01.

Location

Transplantation Institute, Warsaw Medical University, Warsaw, Poland.

Summary of Results:

Test	PT Group Start (N=32)	PT Group End	Significance	CT Group Start (N=37)	CT Group End	Significance
Creatinine (mg/dL)	5.89±2.001	1.48±0.9	P<0.001	7.14±2.5	1.91±0.58	P<0.001
Glucose (md/dL)	102.14±20.6	82.7±13.5	P<0.001	108.18±37.05	83±20	P<0.001
t-Hcy (umol/L)	26.35±7.7	22.5±5.2	P<0.001	29.84±11.5	23.06±7.2	P<0.001
IL-18 (pg/mL)	424.68±226	458.98	NS	383±224	335±240	NS
T-Chol (mmol/L)	5.55±1.38	6.92±1.6	P<0.001	5.4±1.42	6.85±2.16	P<0.001
LDL (mmol/L)	3.22±0.94	4.04±1.51	P<0.001	3.19±0.87	4.35 ±1.84	P<0.01
HDL (mmol/L)	1.29±0.42	1.67±0.53	P<0.01	1.42±0.51	1.51±0.5	P<0.05
T-Chol:HDL Ratio	4.3	4.14	NS	3.8	4.8	P<0.01

It appears that the "start" implies immediately after transplant and "end" may imply at the end of the hospital stay.

Author Conclusion:

The author did note that hypercholeserolemia, hypertriglyceridemia, hyperhomocyseinemia and elevated IL-18 were present in renal transplant recipients who either did or did not receive early physical therapy.

Funding Source:

Government:

State Committee For Research

Reviewer Comments:

This was a poorly-conducted study and it was difficult to interpret.

The treatment group and the control group were not comparible (especially when looking at BMI and smokers, which are atherosclerotic risk factors)
The actual treatment time for the exercise group was very short and not clearly specified (it appears to be three to four weeks; during hospital stay)
The treatment group had additional tests conducted on them to evaluate their respiratory and circulatory systems that the control group did not have, therefore there was no comparison
In the methods section, it reports that the patients were followed subsequently for a period of six months or one year (data not included). The exclusion of this data is suspect. This data would have been more meaningful as we would expect to see potential changes in cholesterol after a longer period of time exercising.
There was an error in reporting the number of males and females, as there was a discrepancy between the Patients and Methods section and the Results section
Attrition was not discussed. It was likely quite high in the six months' and 12 months' follow-up, yet that was not reported
The correlations performed do not seem to support the research question.

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?		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?	No
	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?		No
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	No
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	No
	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?	No
	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?		No
	4.1.	Were follow-up methods described and the same for all groups?	No
	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%.)	No
	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?	No
	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?	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?		No
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	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?	No
	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?	No
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	No
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?	No
	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?	No
	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)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	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?	No
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?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes