-
1.
Effects of combined training on metabolic profile, lung function, stress and quality of life in sedentary adults: A study protocol for a randomized controlled trial.
Ferreira, JP, Duarte-Mendes, P, Teixeira, AM, Silva, FM
PloS one. 2022;(2):e0263455
Abstract
BACKGROUND Both physical inactivity and sedentary behavior are considered modifiable risk factors for chronic diseases and all-cause mortality. Adult office-workers spend most of their working day in sedentary behaviors, so they are particularly at high risk of developed chronic diseases (e.g., cardiovascular diseases, metabolic disorders like diabetes mellitus, …). It seems important to promote behavioral changes that could prevent or delay metabolic disease development. Evidence supports the use of exercise programs, however, to date there are several knowledge gaps and inconsistencies in the literature regarding the effects of Combined Training (i.e., aerobic plus resistance training) in sedentary healthy adults. This paper outlines an RCT designed to evaluate the effects of a 16-week combined training program on biochemical and immune markers of metabolic disease, lung function, salivary stress hormones and subjective quality of life (primary outcomes), as well as on body composition and physical fitness (secondary outcomes) in sedentary middle-aged office-workers. Furthermore, we aimed to assess the associations between the changes promoted by the exercise program and the different variables studied. METHODS AND DESIGN This is a single-blinded two-arm RCT with parallel groups. A minimum of healthy 40 office-workers aged 40-64 years will be recruited to engage in a 16-week intervention study. After baseline assessments, participants will be randomized to one of the two groups: (1) combined training group or (2) control group. Baseline assessments will be repeated after 8 weeks of intervention (mid-testing) and upon completion of the intervention (post-testing). DISCUSSION This RCT involves a multi-disciplinary approach and seems to be a relevant contribution to understanding the potential role of combined training in improving the metabolic profile, lung function, stress, and quality of life in adults. The results can provide important insights for clinical recommendations and for the optimization of strategies to prevent metabolic disorders in adults with sedentary jobs. TRIAL REGISTRATION This trial is registered with ClinicalTrials.gov (registration number: NCT04868240; date of registration April 30, 2021).
-
2.
Effectiveness of a Motivational Nutritional Intervention through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care.
Salamanca-González, P, Valls-Zamora, RM, Pedret-Figuerola, A, Sorlí-Aguilar, M, Santigosa-Ayala, A, Catalin, RE, Pallejà-Millán, M, Solà-Alberich, R, Martin-Lujan, F, The Cenit Research Group Investigators,
Nutrients. 2021;(10)
Abstract
BACKGROUND Diet can help preserve lung function in smokers, as well as aid individuals who avoid smoking. This study aimed to evaluate the effectiveness of a nutritional intervention, using the Social Networks 2.0 tool, to increase adherence to the Mediterranean diet (MD) and improve lung function in smokers without prior respiratory disease. METHODS A randomized controlled parallel design was used. The participants were assigned to either the intervention or control group. Data from representative smokers without respiratory disease (n = 77) aged 18-70 years were analyzed. The participants completed a validated semi-quantitative food-frequency questionnaire, and their adherence to the diet was evaluated by using the questionnaire called the Mediterranean Diet Adherence Score (MEDAS, with 14 items), which considers ≥9 points to indicate high adherence. The lung function was assessed by spirometry. Associations among variables were determined by logistic regression. RESULTS A comparison of the variables at the end of the study between the control and intervention groups showed that the intervention significantly increased adherence to the MD based on the MEDAS questionnaire (0.69 (2.1) vs. 2.05 (2.03); p = 0.009). Specifically, the consumption of fruits was increased after two years in both groups; however, a more significant increase was detected in the intervention group (121 (178) vs. 12.7 (167) in the control group; p-value = 0.008). In the unadjusted analysis, the intervention only showed a statistical significant increase in the score of adherence to the MD (β: 1.36; 95% CI 0.35; 2.3; p = 0.009), and this increase was maintained after adjusting for age and sex (β: 1.15; 95% CI 0.05; 2.2; p = 0.040) and after adjusting for various sociodemographic, lifestyle and anthropometric variables (β: 1.17; 95% CI 0.02; 2.31; p = 0.046). The pulmonary function parameters improved more in the intervention group; however, no significant differences were observed between the two groups. CONCLUSIONS A nutritional intervention based on a dietetic-nutritional education program resulted in a significant increase in adherence to the MD. However, some evidence suggests that an MD dietary intervention can improve lung function, but in our study, we were not able to demonstrate this. Further research is needed to obtain more robust data and confirm a possible benefit of the program before it can be extended to general practice.
-
3.
Lung Ultrasound-Guided Dry Weight Assessment and Echocardiographic Measures in Hypertensive Hemodialysis Patients: A Randomized Controlled Study.
Loutradis, C, Papadopoulos, CE, Sachpekidis, V, Ekart, R, Krunic, B, Karpetas, A, Bikos, A, Tsouchnikas, I, Mitsopoulos, E, Papagianni, A, et al
American journal of kidney diseases : the official journal of the National Kidney Foundation. 2020;(1):11-20
Abstract
RATIONALE & OBJECTIVE Left ventricular (LV) hypertrophy and dysfunction are associated with adverse outcomes in hemodialysis patients. Hypertension and hypervolemia play important roles in these cardiac abnormalities. We report on the prespecified secondary outcome, echocardiographic indexes of LV function, from a previously reported study of the effect of lung ultrasound (US)-guided dry weight reduction on systolic blood pressure. STUDY DESIGN Single-blind randomized trial. SETTINGS & PARTICIPANTS 71 clinically euvolemic hypertensive hemodialysis patients in Greece and Slovenia. INTERVENTION The active intervention group's (n=35) volume removal was guided by the total number of lung US B-lines observed every week before a midweek dialysis session. The usual-care group (n=36) was treated using standard-of-care processes that did not include acquisition of US data. OUTCOMES 2-dimensional and tissue Doppler echocardiographic indexes at baseline and study end (8 weeks) that evaluated left and right heart chamber sizes, as well as systolic and diastolic function. RESULTS Overall, 19 (54%) patients in the active intervention and 5 (14%) in the usual-care group had ultrafiltration intensification (P<0.001) during follow-up; changes in US B-lines (-5.3±12.5 vs+2.2±7.6; P<0.001) and dry weight (-0.71±1.39 vs+0.51±0.98kg; P<0.001) significantly differed between the active and usual-care groups. Inferior vena cava diameter decreased in the active compared with the usual-care group (-0.43±4.00 vs 0.71±4.82cm; P=0.03) at study end. Left (LA) and right (RA) atrial dimensions decreased more in the active group (LA surface, -1.09±4.61 vs 0.93±3.06cm2; P=0.03; RA surface -1.56±6.17 vs 0.47±2.31; P=0.02). LA volume index nominally decreased more in the active group (-2.43±13.14 vs 2.95±9.42mL/m2), though this was of borderline statistical significance (P=0.05). Reductions in LV end-diastolic diameter and volume were marginally greater in the active group. The change in LV filling pressures was significantly different in the active compared with the usual-care group (early transmitral diastolic velocities ratio [E/e'], -0.38±3.14 vs 1.36±3.54; P=0.03; E wave deceleration time, 35.43±85.25 vs-18.44±50.69; P=0.002]. Systolic function indexes were unchanged in both groups. In multivariable analysis, US B-line reduction was associated with a reduction in the E/e' LV ratio (OR, 4.542; 95% CI, 1.266-16.292; P=0.02). LIMITATIONS Exploratory study; small sample size. CONCLUSIONS A US-guided strategy for dry weight reduction is associated with decreased cardiac chamber dimensions and LV filling pressure, but no difference in systolic performance compared with usual care in hypertensive hemodialysis patients. FUNDING European Renal Association-European Dialysis and Transplant Association. TRIAL REGISTRATION Registered at ClinicalTrials.gov with study number NCT03058874.
-
4.
Oral cysteamine as an adjunct treatment in cystic fibrosis pulmonary exacerbations: An exploratory randomized clinical trial.
Devereux, G, Wrolstad, D, Bourke, SJ, Daines, CL, Doe, S, Dougherty, R, Franco, R, Innes, A, Kopp, BT, Lascano, J, et al
PloS one. 2020;(12):e0242945
Abstract
BACKGROUND Emerging data suggests a possible role for cysteamine as an adjunct treatment for pulmonary exacerbations of cystic fibrosis (CF) that continue to be a major clinical challenge. There are no studies investigating the use of cysteamine in pulmonary exacerbations of CF. This exploratory randomized clinical trial was conducted to answer the question: In future pivotal trials of cysteamine as an adjunct treatment in pulmonary exacerbations of CF, which candidate cysteamine dosing regimens should be tested and which are the most appropriate, clinically meaningful outcome measures to employ as endpoints? METHODS AND FINDINGS Multicentre double-blind randomized clinical trial. Adults experiencing a pulmonary exacerbation of CF being treated with standard care that included aminoglycoside therapy were randomized equally to a concomitant 14-day course of placebo, or one of 5 dosing regimens of cysteamine. Outcomes were recorded on days 0, 7, 14 and 21 and included sputum bacterial load and the patient reported outcome measures (PROMs): Chronic Respiratory Infection Symptom Score (CRISS), the Cystic Fibrosis Questionnaire-Revised (CFQ-R); FEV1, blood leukocyte count, and inflammatory markers. Eighty nine participants in fifteen US and EU centres were randomized, 78 completed the 14-day treatment period. Cysteamine had no significant effect on sputum bacterial load, however technical difficulties limited interpretation. The most consistent findings were for cysteamine 450mg twice daily that had effects additional to that observed with placebo, with improved symptoms, CRISS additional 9.85 points (95% CI 0.02, 19.7) p = 0.05, reduced blood leukocyte count by 2.46x109 /l (95% CI 0.11, 4.80), p = 0.041 and reduced CRP by geometric mean 2.57 nmol/l (95% CI 0.15, 0.99), p = 0.049. CONCLUSION In this exploratory study cysteamine appeared to be safe and well-tolerated. Future pivotal trials investigating the utility of cysteamine in pulmonary exacerbations of CF need to include the cysteamine 450mg doses and CRISS and blood leukocyte count as outcome measures. CLINICAL TRIAL REGISTRATION NCT03000348; www.clinicaltrials.gov.
-
5.
Improved lung function at age 6 in children born very preterm and fed extra protein post-discharge.
Toftlund, LH, Agertoft, L, Halken, S, Zachariassen, G
Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology. 2019;(1):47-54
Abstract
BACKGROUND In very preterm-born children, alveolar maturation is challenged and lung function is often compromised during childhood. So far, very few studies have focused on type of early nutrition and lung function in children born preterm. METHODS This study is a 6 years follow-up of 281 very preterm-born infants (VPI) with a gestational age (GA) <32 + 0 weeks. Infants breastfed at discharge from hospital were randomized to unfortified (UHM) or fortified (FHM) mother's (human) milk, whereas those not breastfed received a preterm formula (PF). The intervention lasted until 4 months corrected age. At 6 years of age fractional exhaled nitric oxide (FeNO), airway resistance and occlusion measurements with reversibility were performed. Data on predisposition to asthma and allergy as well as possible allergic symptoms of the child were obtained with questionnaires. RESULTS Outcome data was fully or partially available on 160 (66.9%) of 239 children. This included 49 (30.6%) children fed UHM, 58 (36.3%) fed FHM and 53 (33.1%) fed PF. Successful FeNO measurements were obtained in 119 (74.4%) children and airway resistance measurements in 160. FeNO results were not significantly different between feeding groups. Children fed a protein-enriched diet (FMH/PF) had the lowest, for example, best, airway resistance; FHM-fed had lower values than UHM-fed (P = 0.042) before, and PF-fed had significantly lower values than UHM-fed after beta-2-agonist inhalation (P = 0.050). The tendency of lower airway resistance when protein enriched were the same in gender-specific analyses. In SGA children, the same tendency was found between PF- and UHM-fed (P = 0.007 before and P = 0.046 after beta-2-agonist inhalation). All values were within reference limits. CONCLUSIONS Lung function in very preterm-born children may improve when fed a protein-enriched nutrition post-discharge.
-
6.
Vitamin D inhibits pro-inflammatory cytokines in the airways of cystic fibrosis patients infected by Pseudomonas aeruginosa- pilot study.
Olszowiec-Chlebna, M, Koniarek-Maniecka, A, Brzozowska, A, Błauż, A, Rychlik, B, Stelmach, I
Italian journal of pediatrics. 2019;(1):41
Abstract
BACKGROUND Vitamin D plays an important role in inflammatory responses after antigen exposure. Interleukin-23 (Il-23) promotes Il-17-dependent inflammation during Pseudomonas aeruginosa (P. aeruginosa) pulmonary infection. We aimed to compare the ability of calcitriol and cholecalciferol to modulate the inflammatory response of the CF airways infected with P. aeruginosa. METHODS This was a randomized, placebo-controlled, double-blind, cross-over trial. Twenty-three patients with CF (aged 6-19), chronically infected by P. aeruginosa were randomly assigned to: calcitriol group receiving 1,25(OH)2D 0,5 mcg daily or cholecalciferol group receiving cholecalciferol 1000 IU daily for three months. The levels of Il-23 and Il-17A in the exhaled breath concentrate (EBC) were measured. Calcium-phosphorus balance was also evaluated (serum concentration of calcium, phosphorus, 25OHD, parathormone (PTH) and calcium/creatinine ratio in urine). Data were analyzed using means of Stata/Special Edition, release 14.2. A level of P < 0.05 was considered statistically significant. RESULTS The level of Il-17A in EBC significantly decreased in calcitriol group from 0,475 pg/mL (± SD 0,515 pg/mL) to 0,384 pg/mL (± SD 0,429 pg/mL) (p = 0,008); there was no change in cholecalciferol group (p = 0,074). The level of Il-23 in EBC did not significantly change in calcitriol group (p = 0,086); there was significant decrease in cholecalciferol group from 8,90 pg/mL (± SD 4,07 pg/mL) to 7,33 pg/mL (± SD 3,88 pg/mL) (p = 0,001). In calcitriol group serum phosphorus and PTH significantly decreased (p = 0,021 and p = 0,019 respectively), the concentration of calcium significantly increased (p = 0,001); there were no changes in cholecalciferol group. CONCLUSIONS Both analogs of vitamin D revealed their anti-inflammatory effect and reduced the level of Il-17A and Il-23 in the airway of CF patients with chronic P. aeruginosa infection. We observed improvement in calcium-phosphorus metabolism after supplementation with calcitriol, without adverse effects. It is recommended to use vitamin D in CF patients.
-
7.
Effect of Creatine Supplementation on the Airways of Youth Elite Soccer Players.
Simpson, AJ, Horne, S, Sharp, P, Sharps, R, Kippelen, P
Medicine and science in sports and exercise. 2019;(8):1582-1590
-
-
Free full text
-
Abstract
INTRODUCTION Owing to its well-established ergogenic potential, creatine is a highly popular food supplement in sports. As an oral supplement, creatine is considered safe and ethical. However, no data exist on the safety of creatine on lung function in athletes. The aim of this project was to evaluate the effects of a standard course of creatine on the airways of youth elite athletes. METHODS Nineteen elite soccer players, 16-21 yr old, completed a stratified, randomized, double-blind, placebo-controlled, parallel-group trial. The creatine group (n = 9) ingested 0.3 g·kg⋅d of creatine monohydrate (CM) for 1 wk (loading phase) and 5 g·d for 7 wk (maintenance phase), and the placebo group (n = 10) received the same dosages of maltodextrin. Airway inflammation (assessed by exhaled nitric oxide, FENO) and airway responsiveness (to dry air hyperpnoea) were measured pre- and postsupplementation. RESULTS Mild, unfavorable changes in FENO were noticed by trend over the supplementation period in the CM group only (P = 0.056 for interaction, η = 0.199), with a mean group change of 9 ± 13 ppb in the CM group versus -5 ± 16 ppb in the placebo group (P = 0.056, d = 0.695). Further, the maximum fall in forced expiratory volume in 1 s after dry air hyperpnoea was larger by trend postsupplementation in the CM group compared with the placebo group: 9.7% ± 7.5% vs 4.4% ± 1.4%, respectively (P = 0.070, d = 0.975). These adverse effects were more pronounced when atopic players only (n = 15) were considered. CONCLUSION On the basis of the observed trends and medium to large effect sizes, we cannot exclude that creatine supplementation has an adverse effect on the airways of elite athletes, particularly in those with allergic sensitization. Further safety profiling of the ergogenic food supplement is warranted.
-
8.
Subcutaneous advanced glycation end-products and lung function according to glucose abnormalities: The ILERVAS Project.
Sánchez, E, Lecube, A, Betriu, À, Hernández, C, López-Cano, C, Gutiérrez-Carrasquilla, L, Kerkeni, M, Yeramian, A, Purroy, F, Pamplona, R, et al
Diabetes & metabolism. 2019;(6):595-598
-
9.
A clinical trial to evaluate the effect of the Mediterranean diet on smokers lung function.
Martín-Luján, F, Catalin, RE, Salamanca-González, P, Sorlí-Aguilar, M, Santigosa-Ayala, A, Valls-Zamora, RM, Martín-Vergara, N, Canela-Armengol, T, Arija-Val, V, Solà-Alberich, R
NPJ primary care respiratory medicine. 2019;(1):40
Abstract
Data on the association between lung function and some dietary patterns have been published. However, it is not yet well known if whether the Mediterranean Diet (MD) pattern can preserve or improve lung function. Our purpose is to evaluate the effect of increased MD adherence on lung function in smokers. A multicenter, parallel, cluster-randomized, controlled clinical trial is proposed. A total of 566 active smokers (>10 packs-year), aged 25-75 years will be included, without previous respiratory disease and who sign an informed consent to participate. Twenty Primary Care Centres in Tarragona (Spain) will be randomly assigned to a control or an intervention group (1:1). All participants will receive advice to quit smoking, and the intervention group, a nutritional intervention (2 years) designed to increase MD adherence by: (1) annual visit to deliver personalized nutritional education, (2) annual telephone contact to reinforce the intervention, and (3) access to an online dietary blog. We will evaluate (annually for 2 years): pulmonary function by forced spirometry and MD adherence by a 14-item questionnaire and medical tests (oxidation, inflammation and consumption biomarkers). In a statistical analysis by intention-to-treat basis, with the individual smoker as unit of analysis, pulmonary function and MD adherence in both groups will be compared; logistic regression models will be applied to analyze their associations. We hope to observe an increased MD adherence that may prevent the deterioration of lung function in smokers without previous respiratory disease. This population may benefit from a dietary intervention, together with the recommendation of smoking cessation.
-
10.
Impact of vitamin D on spirometry findings and quality of life in patients with chronic obstructive pulmonary disease: a randomized, double-blinded, placebo-controlled clinical trial.
Alavi Foumani, A, Mehrdad, M, Jafarinezhad, A, Nokani, K, Jafari, A
International journal of chronic obstructive pulmonary disease. 2019;:1495-1501
Abstract
COPD is an irreversible chronic illness with airflow limitation. The aim of the current study was to assess the role of vitamin D3 on quality of life and pulmonary function in patients with COPD. A randomized, double-blinded clinical trial was conducted in 63 patients with COPD. Patients were placed into intervention and placebo groups. Each individual in the intervention group took 50,000 IU vitamin D3once a week for 8 weeks and then once a month for 4 months. There was no significant difference among FEV1, FEV1/FVC, and number of exacerbations in patients with COPD (P>0.05). In the intervention group, a significant difference was observed in quality of life at 2 months (P<0.001) and 6 months (P<0.001). In addition, qualitative analysis showed that the status of exacerbation had not got worse six months after initiation in the intervention group. The current study shows that consumption of 50,000 IU vitamin D3, as a convenient supplementation in a daily diet, is able to increase quality of life in patients with COPD.