Multidisciplinary Prehabilitation and Postoperative Rehabilitation for Avoiding Complications in Patients Undergoing Resection of Colon Cancer: Rationale, Design, and Methodology of the ONCOFIT Study.

ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary Prehabilitation and Postoperative Program (PPP) on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care. Primary and secondary endpoints will be assessed at baseline, at preoperative conditions, at the end of the PPP intervention (after 12 weeks) and 1-year post-surgery, and will include: post-surgery complications (primary endpoint); prolonged hospital length of stay; readmissions and emergency department call within 1-year after surgery; functional capacity; patient reported outcome measures targeted; anthropometry and body composition; clinical/tumor parameters; physical activity levels and sedentariness; dietary habits; other unhealthy habits; sleep quality; and fecal microbiota diversity and composition. Considering the feasibility of the present intervention in a real-life scenario, ONCOFIT will contribute to the standardization of a cost-effective strategy for preventing and improving health-related consequences in patients undergoing resection of colon cancer with an important clinical and economic impact, not only in the scientific community, but also in clinical practice.

Clinical, physical, physiological, and cardiovascular risk patterns of adults with schizophrenia: CORTEX-SP study: Characterization of adults with schizophrenia.

Schizophrenia (SP) is a severe mental illness with high rates of premature morbidity and mortality, associated with an unhealthy lifestyle and the side effects of drug treatment. The aims of the study were: 1) to determine some key physical, physiological and biochemical markers of health status, including sleep quality, in adults (42±10 yr) with SP (n=126), 2) to estimate cardiovascular risk (CVR), and 3) to compare all studied variables with a healthy control (HC) population (n=30). Assessment was based on body composition, blood pressure, cardiorespiratory condition, sleep quality with triaxial accelerometry for eight days and biochemical analysis. Participants with SP showed a cardiovascular risk profile including "overweight metabolically abnormal", low cardiorespiratory fitness, and impairment of ventilatory efficiency. Although individuals with SP slept more compared to HC, similar sleep efficiency was shown by both groups, but with significantly higher levels of wake after sleep onset by SP. The assessment of CVR revealed significantly higher values in SP (moderate risk) compared to HC (low risk) regardless of the estimation system. The identification of specific clinical, physical, and physiological CVR profiles in SP illness compared to healthy people strongly suggests targeting a comprehensive approach including non-pharmacological interventions. Clinical Trials.gov identifier, NCT03509597. Date of registration: April 26th, 2018.

Impact on Health-Related Quality of Life after Different Aerobic Exercise Programs in Physically Inactive Adults with Overweight/Obesity and Primary Hypertension: Data from the EXERDIET-HTA Study.

Primary hypertension (HTN) and obesity are associated with a worse health-related quality of life (QoL). This research was carried out to analyze the health-related QoL measurements in a physically inactive and obese population with HTN (n = 253) in comparison to a HEALTHY sample (n = 30), to determine the HTN sample changes in QoL following different (high-volume moderate-intensity continuous training, high-volume high-intensity interval training (HIIT), low-volume HIIT) 16-week supervised aerobic exercise training (ExT) programs compared to attention control, and to assess the differences in QoL variables between the different ExT programs. The SF-36 questionnaire was used to assess health-related QoL. At baseline, HTN showed lower scores (p < 0.05) in physical function (88.6 vs. 99.2), general health (63.3 vs. 82.4), vitality (58.2 vs. 68.7), social functioning (88.5 vs. 95.2), and mental health (76.1 vs. 81.8) compared to HEALTHY. Following intervention, all HTN subgroups showed higher (p < 0.05) vitality, but physical functioning and general health significantly improved only in the ExT groups, with even better values in general health for both HIIT subgroups. Only the low-volume HIIT showed positive changes (p < 0.05) in social functioning (∆ = 6.9%) and mental health (∆ = 6.4%) domains after the intervention. These results highlight the important role of supervised exercise in improving physical and psychological health.

Physical Activity, Sedentary Behavior, and Sleep Quality in Adults with Primary Hypertension and Obesity before and after an Aerobic Exercise Program: EXERDIET-HTA Study.

BACKGROUND: The purposes of the study were to: analyze, by objective (accelerometry) and subjective (International Physical Activity Questionnaire, IPAQ) methodologies, the physical activity (PA) and sedentary behavior (SB) in healthy adults (HEALTHY, n = 30) and individuals with primary hypertension (HTN) and overweight/obesity (n = 218); assess the effects of an aerobic exercise intervention on physical activity (PA), sedentary behavior (SB), and sleep quality in the HTN group; and evaluate the relationship between objectively measured and subjectively reported PA and SB. METHODS: The measurements were performed before a 16-week exercise intervention period in both HEALTHY and HTN groups and after the intervention period only in the HTN group, randomized to attention control or exercise training (ExT) subgroups. RESULTS: The HEALTHY group showed more moderate-to-vigorous PA (p < 0.05) and better sleep quality (p < 0.05) than the HTN group, but no difference in SB. After the intervention, HTN participants' PA and SB, objectively measured by accelerometry, were unchanged, but increased PA and decreased SB (p < 0.05) were observed through IPAQ in ExT. The intervention was effective in improving sleep quality in HTN participants. CONCLUSIONS: The differences in moderate-to-vigorous PA and SB may be useful in defining the health profile of a population. The supervised aerobic exercise program was effective in increasing PA, reducing SB, and improving sleep quality in overweight/obese adults with HTN. Accelerometer-measured and self-reported data were not comparable, but complementary.

A Metabolically Healthy Profile Is a Transient Stage When Exercise and Diet Are Not Supervised: Long-Term Effects in the EXERDIET-HTA Study.

Metabolically unhealthy obesity (MUO) is a regular state in people with primary hypertension (HTN), obesity, and who are physically inactive. To achieve and maintain a metabolically healthy overweight/obese (MHO) state should be a main treatment goal. The aims of the study were (1) to determine differences in metabolic profiles of overweight/obese, physically inactive individuals with HTN following a 16-week (POST) supervised aerobic exercise training (SupExT) intervention with an attentional control (AC) group, and (2) to determine whether the changes observed were maintained following six months (6 M) of unsupervised time. Participants (n = 219) were randomly assigned into AC or SupExT groups. All participants underwent a hypocaloric diet. At POST, all participants received diet and physical activity advice for the following 6 M, with no supervision. All measurements were assessed pre-intervention (PRE), POST, and after 6 M. From PRE to POST, MUO participants became MHO with improved (p < 0.05) total cholesterol (TC, ∆ = -12.1 mg/dL), alanine aminotransferase (∆ = -8.3 U/L), glucose (∆ = -5.5 mg/dL), C-reactive protein (∆ = -1.4 mg/dL), systolic blood pressure (SBP), and cardiorespiratory fitness (CRF) compared to unhealthy optimal cut-off values. However, after 6 M, TC, glucose, and SBP returned to unhealthy values (p < 0.05). In a non-physically active population with obesity and HTN, a 16-week SupExT and diet intervention significantly improves cardiometabolic profile from MUO to MHO. However, after 6 M of no supervision, participants returned to MUO. The findings of this study highlight the need for regular, systematic, and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.

Effects of different aerobic exercise programs on cardiac autonomic modulation and hemodynamics in hypertension: data from EXERDIET-HTA randomized trial.

The aims of the present study were to analyze the effects of 16 weeks of different aerobic exercise training (ExT) programs with diet on cardiac autonomic modulation and hemodynamics in nonphysically active and overweight/obese adults (n = 249, 53.7 ± 8.0 years) with primary hypertension, and the possible differences among ExT programs and their effects on heart rate (HR), blood pressure (BP), and long-term BP variability (BPV). Participants were randomly assigned into an attention control (AC) group (physical activity recommendations) or one of three supervised ExT groups: high volume of moderate-intensity continuous training, high-volume and high-intensity interval training (HIIT), and low-volume-HIIT. Twenty-four hours of ambulatory BP monitoring was used to analyze systolic (SBP) and diastolic (DBP) BP, HR, and BPV. A cardiopulmonary exercise test was performed to determine peak oxygen uptake (VO2peak). Following intervention, resting and submaximal exercise (HR, SBP, and DBP), along with diurnal and nocturnal SBP and DBP values decreased (P < 0.05) in all groups with no differences between groups. When the ExT groups were combined, submaximal SBP (P = 0.048) and DBP (P = 0.004), VO2peak (P = 0.014) and HR reserve (P = 0.030) were significantly improved compared with AC. Intervention did not have significant effects on BPV. In the present study better improvements in the autonomic nervous system were seen when the aerobic ExT was individually designed and supervised with pari passu effects irrespective of exercise intensity and volume. Low-volume-HIIT ExT combined with a healthy diet should be considered as a time efficient and safe mechanism for reducing the cardiovascular risk in hypertensive individuals.

Long-Term Effects in the EXERDIET-HTA Study: Supervised Exercise Training vs. Physical Activity Advice.

Purpose: To determine whether improvements in cardiorespiratory fitness (CRF), blood pressure (BP) and body composition previously seen after a 16-week exercise intervention (POST) with hypocaloric diet are maintained following six months (6M) of unsupervised exercise time. Methods: Overweight/obese, physically inactive participants with primary hypertension (HTN) (n = 190) were randomly assigned into an attention control group (physical activity recommendations) or one of three supervised exercise groups. After POST, all participants received diet and physical activity advice for the following 6M but no supervision. All anthropometric and physiological measurements were taken pre and post the 16-week supervised intervention period, as well as after 6M of no supervision. Results: After 6M: 1) body mass (BM) (Δ = 2.5%) and waist circumference (Δ = 1.8%) were higher (P < .005) than POST, but lower (P < .005) than pre-intervention (BM, Δ = -5.1%; waist circumference, Δ = -4.7%), with high-volume and high-intensity interval training group revealing a higher BM reduction (Δ = -6.4 kg) compared to control group (Δ = -3.5 kg); 2) BP variables were higher (P < .001) compared to POST with no change from pre-intervention; and 3) CRF was higher compared to pre-intervention (Δ = 17.1%, P < .001) but lower than POST (Δ = -5.7%, P < .001). Conclusions: When an overweight/obese population with HTN attains significant improvements in cardiometabolic health POST intervention with diet restriction, there is a significant reduction following 6M when exercise and diet supervision is removed, and only recommendations were applied. These results suggest the need for a regular, systematic and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.

Actigraphy-based sleep analysis in sedentary and overweight/obese adults with primary hypertension: data from the EXERDIET-HTA study.

PURPOSE: The aim of this study was to analyze actigraphy-based sleep quantity and quality in sedentary and overweight/obese adults with primary hypertension (HTN) divided by sex and cardiorespiratory fitness (CRF) and to assess the association of sleep parameters with body composition, blood pressure (BP), and CRF. METHODS: This is a cross-sectional design utilizing data from the EXERDIET-HTA study conducted in 154 non-physically, obese adults with HTN (53.3 ± 7.8 years). Sleep parameters (total bedtime; total sleep time, TST; and sleep efficiency = (TST/total bedtime) × 100)) were calculated from raw accelerometer data (ActiGraph GT3X+). Peak oxygen uptake (V̇O2peak) determined the CRF. Blood pressure was assessed with the 24-h ambulatory BP monitoring. The distributions of V̇O2peak were divided into tertiles (low, medium, and high CRF) in each sex. Series of linear regression analyses were conducted between sleep, fitness, and health-related variables. RESULTS: Short sleep duration (6.2 h) both on weekdays and weekends, poor sleep quality (< 85% of efficiency), and no significant differences in sleep variables between women and men, nor among CRF groups, were observed. The short sleeping pattern was negatively associated (P < 0.05) with mean and night systolic BP (mmHg, ß = - 0.2), and sleep efficiency with waist circumference (cm, ß = - 0.08, P = 0.05). CONCLUSIONS: Actigraphy-based sleep analysis reinforces that sleep disorders, such as short sleep duration and poor sleep quality, are associated with high BP and abdominal obesity in sedentary adults with overweight/obesity and HTN. Sleep pattern did not appear to be related with CRF level in this population.

Validity of the modified shuttle walk test to assess cardiorespiratory fitness after exercise intervention in overweight/obese adults with primary hypertension.

The study aimed to assess whether the Modified Shuttle Walk Test (MSWT) can detect changes in cardiorespiratory fitness (CRF) in overweight/obese people with hypertension (HTN) after an exercise intervention evaluating the equation presented in the previous research by Jurio-Iriarte et al. Participants (N= 248) performed a peak cardiorespiratory exercise test (CPET) and MSWT before and after 16-weeks of different types of aerobic exercise intervention. The formula of Jurio-Iriarte et al. was used to predict peak oxygen uptake (V̇O2peak). The correlation between measured and predicted V̇O2peak was strong (r= 0.76, P< 0.001) with a standard error of estimate (SEE) of 4.9 mL·kg-1·min-1; SEE%= 17%. The intraclass correlation coefficient indicates a moderate level of association and agreement (ICC= 0.69; 95% CI 0.34-0.82; P< 0.001) between the measured and predicted V̇O2peak. When analyzing obese participants alone (N= 128), MSWT equation was more accurate compared to the whole sample (ICC= 0.76; 95% CI 0.52-0.87). The relationship between the change of measured and predicted V̇O2peak at follow-up was weak (r= 0.42, P< 0.001) with a 31% SEE, and a low level of association and agreement (ICC= 0.31; 95% CI 0.06-0.49; P< 0.001). In conclusion, although MSWT does not accurately predict CRF in people with HTN after exercise intervention and questions its validity, the new equation may have practical application to estimate V̇O2peak for obese people with HTN when CPET is not available. Abbreviations: AC: Attention Control; BM: Body Mass; BP: Blood Pressure; CI: Confidence Interval; CRF: Cardiorespiratory Fitness; CPET: Cardiopulmonary Exercise Test; HTN: Primary Hypertension; HR: Heart Rate; HV-HIIT: High-Volume and High-Intensity Interval Training; ICC: Intraclass Correlation Coefficient; LV-HIIT: Low-Volume and High-Intensity Interval Training; MICT: Moderate-intensity continuous training; MSWT: Modified Shuttle Walk Test; SD: Standard Deviation; SEE: Standard Error of Estimate; V̇O2peak: Peak Oxygen Uptake.

Is cardiorespiratory fitness independently associated with the biochemical profile in overweight/obese adults with primary hypertension? The EXERDIET-HTA study.

Cardiorespiratory fitness (CRF) is positively associated with enhanced cardiovascular health. This cross-sectional study aimed to determine associations between CRF and the biochemical profile of overweight/obese adults diagnosed with primary hypertension (HTN). Does cardiorespiratory fitness (exposure) positively affect the biochemical profile (outcome) in overweight/obese individuals suffering from HTN? Assessment with anthropometric, ambulatory blood pressure monitoring (24 h), CRF (peak oxygen uptake, V̇O2peak) and biochemical analysis was performed on 214 participants (138 men, 76 women). A series of linear and logistic regression analyses were conducted. Participants were divided into CRF tertiles (classified as low, moderate and high CRF). The CRF was independently and inversely associated with aspartate aminotransferase (AST; ß = -0.328, p < .05) and alanine aminotransferase (ALT; ß = -0.376, p < .01) concentrations. C-reactive protein, AST/ALT ratio, gamma-glutamyl transpeptidase, total cholesterol/high-density lipoprotein cholesterol ratio, glucose, insulin and insulin resistance index (HOMA-IR), were all associated, but not independently, with CRF in linear and/or unadjusted logistic regression models. However, independently, logistic regression revealed that glucose was associated with the moderate CRF group. Findings suggest that a lower CRF is associated with an unhealthy biochemical profile in non-physically active and overweight/obese individuals with HTN. As such, this population should look to increase physical activity in order to improve their CRF and biochemical profile.

Effects on Cardiovascular Risk Scores and Vascular Age After Aerobic Exercise and Nutritional Intervention in Sedentary and Overweight/Obese Adults with Primary Hypertension: The EXERDIET-HTA Randomized Trial Study.

INTRODUCTION: The EXERDIET-HTA study was a multi-arm parallel, a randomized, single-blind controlled experimental trial comparing the effects of 16 weeks of different aerobic exercise programs two days per week, and dietary intervention in a hypertensive, overweight/obese and non-physically active population. AIM: To evaluate the influence of diet and aerobic exercise program intervention on cardiovascular risk (CVR) factors and predicted CVR and vascular age (VA) profiles in overweight/obese people with primary hypertension (HTN), and to analyze the potential sex differences in the ability to predict VA and CVR via different methods. METHODS: The CVR and VA determined (n = 167, 53.7 ± 7.8 years) using the Framingham Risk Score (FRS) and the new equation for the prediction of 10-year atherosclerotic cardiovascular disease (ASCVD) risk, before and after the 16-week intervention period (different aerobic exercise programs + hypocaloric diet). The sex-specific risk factors considered were age, high-density lipoprotein cholesterol (HDL-C), total cholesterol, systolic blood pressure (SBP), diabetes mellitus (DM) and smoking status. RESULTS: From baseline to follow-up, participants reduced (p ≤ 0.001) FRS-CVR score and VA, and SBP. Total cholesterol decreased significantly, but specifically in men (p ≤ 0.001), and antihypertensive medication (%) in women (p = 0.047). No significant differences over time were observed for HDL-C, smoking, DM overall for either sex. For ASCVD-CVR there was no overall change or for either sex. After the intervention, women had a lower CVR score than men (p ≤ 0.001), irrespective of the calculation method. CONCLUSIONS: The improvement in CVR factors after 16-week lifestyle changes reduced the risk of suffering a cardiovascular event in overweight/obese adults with HTN through the FRS estimation tool, but not with the ASCVD score. The risk score algorithms could underestimate CVR in women. In contrast, VA could be a useful and easier tool in the management of individuals with CVR factors.

Effects of different aerobic exercise programmes with nutritional intervention in sedentary adults with overweight/obesity and hypertension: EXERDIET-HTA study.

Background Both exercise training and diet are recommended to prevent and control hypertension and overweight/obesity. Purpose The purpose of this study was to determine the effectiveness of different 16-week aerobic exercise programmes with hypocaloric diet on blood pressure, body composition, cardiorespiratory fitness and pharmacological treatment. Methods Overweight/obese, sedentary participants ( n = 175, aged 54.0 ± 8.2 years) with hypertension were randomly assigned into an attention control group (physical activity recommendations) or one of three supervised exercise groups (2 days/week: high-volume with 45 minutes of moderate-intensity continuous training (MICT), high-volume and high-intensity interval training (HIIT), alternating high and moderate intensities, and low-volume HIIT (20 minutes)). All variables were assessed pre- and post-intervention. All participants received the same hypocaloric diet. Results Following the intervention, there was a significant reduction in blood pressure and body mass in all groups with no between-group differences for blood pressure. However, body mass was significantly less reduced in the attention control group compared with all exercise groups (attention control -6.6%, high-volume MICT -8.3%, high-volume HIIT -9.7%, low-volume HIIT -6.9%). HIIT groups had significantly higher cardiorespiratory fitness than high-volume MICT, but there were no significant between-HIIT differences (attention control 16.4%, high-volume MICT 23.6%, high-volume HIIT 36.7%, low-volume HIIT 30.5%). Medication was removed in 7.6% and reduced in 37.7% of the participants. Conclusions The combination of hypocaloric diet with supervised aerobic exercise 2 days/week offers an optimal non-pharmacological tool in the management of blood pressure, cardiorespiratory fitness and body composition in overweight/obese and sedentary individuals with hypertension. High-volume HIIT seems to be better for reducing body mass compared with low-volume HIIT. The exercise-induced improvement in cardiorespiratory fitness is intensity dependent with low-volume HIIT as a time-efficient method in this population. ClinicalTrials.gov Registration: NCT02283047.

Clinical, physical, physiological, and dietary patterns of obese and sedentary adults with primary hypertension characterized by sex and cardiorespiratory fitness: EXERDIET-HTA study.

The main purpose of this study was to determine some key physical, physiological, clinical, and nutritional markers of health status in obese and sedentary adults (54.0 ± 8.1 years, 141 men and 68 women) with primary hypertension (HTN) characterized by sex and cardiorespiratory fitness (CRF) level. The studied population showed a high cardiovascular risk (CVR) profile including metabolically abnormal obese, with poor CRF level (22.5 ± 5.6 mL·kg-1·min-1), exercise-induced HTN (Systolic Blood Pressure>210 mmHg in men and >190 mmHg in women at the end of the exercise test) and with non-healthy adherence to dietary pattern (Dietary Approaches to Stop Hypertension, 46.3%; Mediterranean Diet, 41.1%; and Healthy Diet Indicator, 37.1%). Women showed a better biochemical and dietary pattern profile than men (lower values, P < 0.05, in triglycerides, mean difference = 26.3; 95% CI = 0.9-51.7 mg/dL, aspartate transaminase, mean difference = 4.2; 95% CI = 0.3-8.0 U/L; alanine transaminase, mean difference = 8.2; 95% CI = 1.6-14.8 U/L; gamma-glutamyl transpeptidase, mean difference = 11.0; 95% CI = -1.1-23.2 U/L and higher values, P = 0.002, in high-density lipoprotein cholesterol, mean difference = 5.0, 95% CI = -13.3-3.3 mg/dL), but physical and peak exercise physiological characteristics were poorer. A higher CRF level might contribute to the attenuation of some CVR factors, such as high body mass index, non-dipping profile, and high hepatic fat. The results strongly suggest that targeting key behaviors such as improving nutritional quality and CRF via regular physical activity will contribute to improving the health with independent beneficial effects on CVR factors.

Reliability of oscillometric central blood pressure responses to lower limb resistance exercise.

BACKGROUND AND AIMS: Although it is well known that resistance training (RT) is beneficial for patients suffering from a variety of cardiovascular diseases, it remains underutilized as a rehabilitation tool as there is no reliable way to monitor the additional stress placed on the central organs. The current study aimed to determine between-day reliability of central haemodynamic indices using oscillometric pulse wave analysis (PWA) during progressive sub-maximal RT. METHODS: Nineteen healthy young males were tested on 3 different mornings in a fasted state. Central hemodynamic variables including augmentation index (AIx), AIx normalized to a heart rate of 75 beats per minute (AIx@75), central systolic blood pressure (cSBP), forwards (Pf) and backwards (Pb) wave reflection were determined at rest, as well as during leg extension RT at 10, 15 and 20% of maximal volitional contraction (MVC), and following 1 min and 5 min passive recovery. RESULTS: During RT at 10, 15 and 20% MVC, the intraclass correlation coefficient (ICC) values for AIx@75 (0.76-0.9), cSBP (0.74-0.78), Pf (0.75-0.82) and Pb (0.75-0.83) exceeded the criteria (0.75) for excellent reliability. During the 5 min recovery, the ICC values for AIx@75 (0.87-0.87), cSBP (0.69-0.7), Pf (0.63-0.67) and Pb (0.63-0.66) indicated good to excellent reliability. CONCLUSIONS: Clinically meaningful changes in central hemodynamic indices can be obtained during resistance training using oscillometric PWA devices. This technology holds potential for advancing resistance training prescription guidelines for patients with overt cardiovascular diseases.