COPD: Effectiveness of Therapies (2007-2008)
- Stable COPD patients with a BMI < 22, fat-free mass index < 16, and/or a recent involuntary weight loss (>5% during last month, or >10% during the last 3 months)
- Fulfilled criteria for COPD according to ATS guidelines
- Signs of an airway infection
- Concomitant confounding diseases such as malignant disorders, recent surgery, GI, cardiovascular, neurological or endocrine disease
- Treated with oral steroids, immunosuppressors or oxygen therapy at home
- Receiving nutritional supplements
Recruitment
Consecutive depleted patients with stable COPD.
Design
Randomized Controlled Trial.
Blinding used (if applicable)
Not used.
Intervention (if applicable)
- Patients were encouraged to ingest total daily defined energy intake, either 1.7 or 1.3 REE based on Harris-Benedict for 12 weeks
- Energy intake was achieved with regular food and if necessary, oral nutritional supplement rich in proteins (50% whey protein), with predominance of carbohydrates over fat, and enriched in antioxidants
Statistical Analysis
For categorical variables, absolute frequencies and percentages used. Significant differences evaluated using Student's t test in normal distribution and Wilcoxon's sum test or Mann-Whitney U test when not normally distributed.
Timing of Measurements
Variables assessed before the nutritional intervention and after 12 weeks.
Dependent Variables
- Quality of life measured by Spanish version of Chronic Respiratory Disease Questionnaire
- Body weight, height, triceps skinfold thickness, mid-arm muscle circumference
- Body composition measured using bioelectrical impedance
- Lung function: FEV1 calculated from flow-volume curve using spirometry
- Handgrip strength measured using Harpenden handgrip dynamometer
Independent Variables
- Total energy intake of 1.7 or 1.3 REE for 12 weeks based on Harris-Benedict
- Dietary intake assessed using 3 day food records
Control Variables
Initial N: 28 outpatients with COPD, 15 in Group A (1.7 REE), 13 in Group B (1.3 REE)
Attrition (final N): 24; 14 in Group A (1.7 REE), 10 in Group B (1.3 REE)
Age: Group A mean age: 60.8 +/- 15.2 years, Group B mean age: 58.8 +/- 19.5 years
Ethnicity: not mentioned
Other relevant demographics:
Anthropometrics: No significant differences between groups at baseline
Location: Spain
Group A -Baseline (n=14) |
Group A - 12 weeks | Group B -Baseline (n=10) | Group B - 12 weeks | |
Total dietary intake (kcal/d) |
1800 +/- 314 | 2609 +/- 244, P = 0.001 | 1749 +/- 265 | 2060 +/- 312, P = 0.02 |
Weight (kg) |
55.3 +/- 8.1 |
58.5 +/- 9.0, P = 0.001 |
55.2 +/- 8.6 |
56.6 +/- 9.6 |
TSF (mm) |
6.3 +/- 2.6 |
8.1 +/- 2.5, P = 0.009 |
7.7 +/- 2.5 |
8.0 +/- 2.1 |
Fat mass (kg) | 14.9 +/- 4.6 | 17.7 +/- 5.2, P = 0.02 | 15.3 +/- 5.0 | 15.6 +/- 5.1 |
FFMI (kg/m2) | 14.6 +/- 1.3 | 13.9 +/- 1.6, P = 0.02 | 15.0 +/- 1.8 | 15.6 +/- 2.3 |
FEV1 (% predicted) | 34.2 +/- 14.6 | 28.3 +/- 9.7 | 37.3 +/- 18.5 | 40.4 +/- 17.7 |
HS (kg) | 17.7 +/- 5.9 | 16.1 +/- 6.5 | 18.6 +/- 7.3 | 21.2 +/- 6.5 |
Other Findings
All patients needed oral nutritional supplements to achieve total daily defined energy intake.
After 12 weeks of follow-up, patients in both groups significantly increased energy intake.
Patients in Group A (1.7 REE) increased body weight (P = 0.001), triceps skinfold thickness (P = 0.009) and body fat mass (P = 0.02), and decreased body fat-free mass index (P = 0.02).
In this group, a marked increase in airflow limitation was observed.
A tendency to increase body weight and handgrip strength, and to decrease airflow limitation was observed in patients from group B (1.3 REE).
Furthermore, patients in the later group showed a significant improvement in the feeling of control over the disease (P = 0.007) and a tendency to better the other criteria in a quality of life scale.
University/Hospital: | Instituto de Salud Carlos |
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) | 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? | ??? | |
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) | No | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | Yes | |
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? | 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? | 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? | Yes | |
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? | Yes | |
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? | 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? | ??? | |
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? | ??? | |
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? | No | |
6.6. | Were extra or unplanned treatments described? | ??? | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | Yes | |
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? | 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? | 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)? | 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? | 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 | |