Enhancing of Women Functional Status with Metabolic Syndrome by Cardioprotective and Anti-Inflammatory Effects of Combined Aerobic and Resistance Training

These data describe the effects of combined aerobic plus resistance training (CT) with regards to risk factors of metabolic syndrome (MetS), quality of life, functional capacity, and pro- and anti-inflammatory cytokines in women with MetS. In this context, thirteen women (35.4±6.2 yr) completed 10 weeks of CT consisting of three weekly sessions of ∼60 min aerobic training (treadmill at 65–70% of reserve heart rate, 30 min) and resistance training (3 sets of 8–12 repetitions maximum for main muscle groups). Dependent variables were maximum chest press strength; isometric hand-grip strength; 30 s chair stand test; six minute walk test; body mass; body mass index; body adiposity index; waist circumference; systolic (SBP), diastolic and mean blood pressure (MBP); blood glucose; HDL-C; triglycerides; interleukins (IL) 6, 10 and 12, osteoprotegerin (OPG) and serum nitric oxide metabolite (NOx); quality of life (SF-36) and Z-Score of MetS. There was an improvement in muscle strength on chest press (p = 0.009), isometric hand-grip strength (p = 0.03) and 30 s chair stand (p = 0.007). There was a decrease in SBP (p = 0.049), MBP (p = 0.041), Z-Score of MetS (p = 0.046), OPG (0.42±0.26 to 0.38±0.19 ng/mL, p<0.05) and NOx (13.3±2.3 µmol/L to 9.1±2.3 µmol/L; p<0.0005). IL-10 displayed an increase (13.6±7.5 to 17.2±12.3 pg/mL, p<0.05) after 10 weeks of training. Combined training also increased the perception of physical capacity (p = 0.011). This study endorses CT as an efficient tool to improve blood pressure, functional capacity, quality of life and reduce blood markers of inflammation, which has a clinical relevance in the prevention and treatment of MetS. Trial Registration Brazilian Clinical Trials Registry (ReBec) - RBR-6gdyvz - http://www.ensaiosclinicos.gov.br/rg/?q=RBR-6gdyvz

Deliverer: who delivered the invertion? Exposure quantity and duration: how many session or epidoses or event were intended to be delivered? How long were they intended to last?
Time span: how long was it intended to take to deliver the intervention to each unit? * Details of the interventions intended for each study condition and how and when they were actually administered, specifically including

Methods
Eligibility criteria for participants, including criteria at different levels in recruitment/sampling plan (e.g., cities, clinics, subjects) Method of recruitment (e.g., referral, self-selection), including the sampling method if a systematic sampling plan was implemented

Title and Abstract
Information on how Unit were allocated to intervention Structured abstract recommended Information on target population or study sample Introduction Background 2 Scientific background and explanation of rationale Theories used in designing behavioral intervention

Reported Paper Section/ Topic Item Number
Title and Abstract 1

Descriptor
How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules' Unit of assignment (the unit being assigned to study condition, e.g., individual, group, community) Method used to assign units to study conditions, including details of any restriction (e.g., blocking, stratification, minimization) Inclusion of aspects employed to help minimize potential bias induced due to non-randomization (e.g., matching)

Specific objectives and hypotheses
Outcomes 6 Clearly defined primary and secondary outcome measures Methods used to collect data and any methods used to enhance the quality of measurements Information on validated instruments such as psychometric and biometric properties Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to study condition assignment; if so, statement regarding how the blinding was accomplished and how it was assessed. Description of the smallest unit that is being analyzed to assess intervention effects (e.g., individual, group, or community) If the unit of analysis differs from the unit of assignment, the analytical method used to account for this (e.g., adjusting the standard error estimates by the design effect or using multilevel analysis) Statistical methods used to compare study groups for primary methods outcome(s), including complex methods of correlated data Follow-up: the number of participants who completed the follow-up or did not complete the follow-up (i.e., lost to follow-up), by study condition Analysis: the number of participants included in or excluded from the main analysis, by study condition Description of protocol deviations from study as planned, along with reasons 12 Participant flow

Results
*Flow of participants through each stage of the study: enrollment, assignment, allocation, and intervention exposure, follow-up, analysis (a diagram is strongly recommended) Enrollment: the numbers of participants screened for eligibility, found to be eligible or not eligible, declined to be enrolled, and enrolled in the study Assignment: the numbers of participants assigned to a study condition Allocation and intervention exposure: the number of participants assigned to each study condition and the number of participants who received each intervention Comparison between study population at baseline and target population of interest 14 Baseline data Data on study group equivalence at baseline and statistical methods used to control for baseline differences Number of participants (denominator) included in each analysis for each study condition, particularly when the denominators change for different outcomes; statement of the results in absolute numbers when feasible 13

Recruitment
Baseline demographic and clinical characteristics of participants in each study condition Baseline characteristics for each study condition relevant to specific disease prevention research Baseline comparisons of those lost to follow-up and those retained, overall and by study condition Dates defining the periods of recruitment and follow-up Baseline demographic and clinical characteristics of participants in each study condition Baseline characteristics for each study condition relevant to specific disease prevention research Baseline comparisons of those lost to follow-up and those retained, overall and by study condition Comparison between study population at baseline and target population of interest Summary of other analyses performed, including subgroup or restricted analyses, indicating which are pre-specified or exploratory Summary of all important adverse events or unintended effects in each study condition (including summary measures, effect size estimates, and confidence intervals)

Discussion
Indication of whether the analysis strategy was "intention to treat" or, if not, description of how non-compliers were treated in the analyses For each primary and secondary outcome, a summary of results for each estimation study condition, and the estimated effect size and a confidence interval to indicate the precision Inclusion of null and negative findings Inclusion of results from testing pre-specified causal pathways through which the intervention was intended to operate, if any Outcomes and estimation 17 Interpretation Generalizability (external validity) of the trial findings, taking into account the study population, the characteristics of the intervention, length of follow-up, incentives, compliance rates, specific sites/settings involved in the study, and other contextual issues General interpretation of the results in the context of current evidence and current theory Interpretation of the results, taking into account study hypotheses, sources of potential bias, imprecision of measures, multiplicative analyses, and other limitations or weaknesses of the study Discussion of results taking into account the mechanism by which the intervention was intended to work (causal pathways) or alternative mechanisms or explanations Discussion of the success of and barriers to implementing the intervention, fidelity of implementation Discussion of research, programmatic, or policy implications