The Effects of High Intensity Functional Training on Cardiometabolic Risk Factors and Exercise Enjoyment in Men and Women With Metabolic Syndrome: a Randomized, 12-week, Dose-response Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Mean change from baseline and comparison between groups in apolipoprotein B (ApoB) count after 12 weeks of training.
研究概览
简要总结
This study aims to explore the dose effects of three weekly volumes of high-intensity functional training (HIFT) on apolipoprotein B (ApoB), triglyceride (TG) and cholesterol (CHOL) content of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), and high-density lipoproteins (HDL) particles, fasting insulin and glucose, glycosylated hemoglobin (HbA1c), and endothelial function after a 12-week training program. Secondarily, this study aims to also explore the subjective dose-responses of "exercise enjoyment" and "intention to continue" after this 12-week training program.
详细描述
Background: Individuals with metabolic syndrome (MetS) are at a greater risk for developing atherosclerotic cardiovascular disease (ASCVD) than those without MetS, due to underlying endothelial dysfunction, dyslipidemia, and insulin resistance. Exercise is an effective primary and secondary prevention strategy for MetS, however less than 25% of adults meet the minimum stated public recommendations. Barriers often identified are lack of enjoyment and lack of time. High intensity functional training (HIFT), a time efficient modality of exercise, has shown some potential to elicit positive affectivity, and elicit increased fitness and improved glucose metabolism. However, the effects of HIFT on dyslipidemia and endothelial dysfunction have not been explored, nor have the effects been explored in a population with MetS. Additionally, no studies have investigated the minimal dose of HIFT per week to see clinically meaningful changes in cardiometabolic health. The purpose of this study is to: 1) determine the dose-response effect of HIFT on blood lipids, insulin resistance, and endothelial function, and 2) determine the dose-response effect of HIFT on body composition, fitness, and perceived enjoyment and intention to continue the exercise.
Methods/design: In this randomized, dose-response trial, participants will undergo a 12-week HIFT intervention of either 1 day/week, 2 days/week, or 3 days/week of supervised, progressive exercise. Outcomes assessed at baseline and post-intervention will be multiple cardiometabolic markers, and fitness. Additionally, the participant's affective response will be measured after the intervention.
Discussion: The findings of this research will provide evidence on the minimal dose of HIFT per week to see clinically meaningful improvements in the risk factors of MetS, as well as whether this modality is likely to mitigate the barriers to exercise. If an effective dose of HIFT per week is determined and if this modality is perceived positively, it may provide exercise specialists and health care providers a tool to prevent and treat MetS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Primary investigator will be blinded from each participant's dose allocation.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physically Inactive (< 30 min/day, 3 days/wk, for 3 months of moderate intensity exercise)
- •Possess at least 3 of the following 5 risk factors defining metabolic syndrome (MetS): waist circumference ≥ 102cm (men) or ≥ 88cm (women), resting blood pressure ≥ 130/85, HDL-C ≤ 40mg/dl (men) or ≤ 50mg/dl (women), fasting triglycerides ≥ 150mg/dl, and fasting blood glucose ≥ 100mg/dl.
排除标准
- •Diagnosed heart, lung, kidney, liver, pancreatic or neurological disease
- •Pregnant or plan to become pregnant
- •Medical or orthopedic conditions preventing participation in exercise
结局指标
主要结局
Mean change from baseline and comparison between groups in apolipoprotein B (ApoB) count after 12 weeks of training.
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of apolipoprotein B will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the triglyceride content of LDL (LDL-T).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of LDL-T will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the cholesterol content of low-density lipoproteins (LDL-C).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of LDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the cholesterol content of very low-density lipoproteins (VLDL-C).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of VLDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the cholesterol content of high-density lipoproteins (HDL-C).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of HDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the total cholesterol (TC) content of all lipoproteins.
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of TC will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the triglyceride content of VLDL (VLDL-T).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of VLDL-T will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the total triglyceride content of all lipoprotein classes (TG).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of TG will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in blood glucose (BG).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of BG will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in blood insulin (INS).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of INS will be measured via venipuncture of the anti-cubital vein and reported in units of mcIU/mL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in the Homeostatic Assessment of Insulin Resistance (HOMA-IR).
时间窗: Baseline and 48hrs post 12-week training completion
The baseline and post-training blood analysis of BG and INS will be used to calculate insulin resistance (IR) using the validated homeostatic model assessment (HOMA) \[Sarafidis et al., 2007; Matthews et al., 1985\]. HOMA-IR will be reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups in glycosylated hemoglobin (HbA1c) after 12 weeks of training.
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training blood analysis of HbA1c will be measured via venipuncture of the anti-cubital vein and reported in units of percent (%). Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.
Mean change from baseline and comparison between groups of endothelial-dependent peak blood flow (PBF).
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training endothelial-dependent PBF of the non-dominant forearm will be measured using venous occlusion strain-gauge plethysmography and reported in units of percent (%). Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) for each variable will be compared between dose groups and male and female subgroups.
Mean change from baseline and comparison between groups of endothelial-dependent area under the curve (AUC) of hyperemia blood flow.
时间窗: Baseline and 48hrs post 12-week training completion
Baseline and post-training endothelial-dependent hyperemia AUC of the non-dominant forearm will be measured using venous occlusion strain-gauge plethysmography. Hyperemia blood flow will be measured for 5 min after a 5 min occlusion period. 30 sec AUC blood flow will be quantified reported in units of percent (%) x time. Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) for each variable will be compared between dose groups and male and female subgroups.
次要结局
- Mean change from baseline and comparison between groups of body lean mass percentage (LM%).(Baseline and 48hrs post 12-week training completion)
- Mean change from baseline and comparison between groups in maximal oxygen consumption (VO2max).(Baseline and 48hrs post 12-week training completion)
- Mean change from baseline and comparison between groups of body fat mass percentage (FM%).(Baseline and 48hrs post 12-week training completion)
- Mean change from baseline and comparison between groups of self-perceived fitness after 12 weeks of training.(Baseline and 48hrs post 12-week training completion)
研究者
Gary Van Guilder
Sponsor Investigator
Western Colorado University