Clinical trial NCT05001126: The Dose-response Effects of High Intensity Functional Training on Metabolic Syndrome Risk Factors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Atherogenic Dyslipidemia
Insulin Resistance
Endothelial Dysfunction
Keywords: Exercise
Lead sponsor: Western Colorado University
Sponsor class: OTHER
Collaborators: name: Western Colorado University
name: Auckland University of Technology
First posted: 2021-08-11
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Three dose groups
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Diagnosed heart, lung, kidney, liver, pancreatic or neurological disease
* Pregnant or plan to become pregnant
* Medical or orthopedic conditions preventing participation in exercise

Primary outcomes:
measure: Mean change from baseline and comparison between groups in apolipoprotein B (ApoB) count after 12 weeks of training.
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in the cholesterol content of low-density lipoproteins (LDL-C).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in the cholesterol content of very low-density lipoproteins (VLDL-C).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in the cholesterol content of high-density lipoproteins (HDL-C).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in the total cholesterol (TC) content of all lipoproteins.
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in the triglyceride content of LDL (LDL-T).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in the triglyceride content of VLDL (VLDL-T).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in the total triglyceride content of all lipoprotein classes (TG).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in blood glucose (BG).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in blood insulin (INS).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in the Homeostatic Assessment of Insulin Resistance (HOMA-IR).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in glycosylated hemoglobin (HbA1c) after 12 weeks of training.
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups of endothelial-dependent peak blood flow (PBF).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups of endothelial-dependent area under the curve (AUC) of hyperemia blood flow.
timeFrame: Baseline and 48hrs post 12-week training completion
Secondary outcomes:
measure: Mean change from baseline and comparison between groups of body fat mass percentage (FM%).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups of body lean mass percentage (LM%).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups in maximal oxygen consumption (VO2max).
timeFrame: Baseline and 48hrs post 12-week training completion
measure: Mean change from baseline and comparison between groups of self-perceived fitness after 12 weeks of training.
timeFrame: Baseline and 48hrs post 12-week training completion
Other outcomes:
measure: Comparison between groups of exercise enjoyment perception after 12 weeks of training.
timeFrame: 24hrs post 12-week training completion
measure: Comparison between groups of the intention to continue their allocated intervention after 12 weeks of training.
timeFrame: 24hrs post 12-week training completion
Locations:
city: Gunnison
country: United States
facility: Western Colorado University
state: Colorado
Study officials:
affiliation: Western Colorado University
name: Lance C Dalleck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Auckland University of Technology
name: Nigel Harris, PhD
role: PRINCIPAL_INVESTIGATOR
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