The Dose-response Effects of High Intensity Functional Training on Metabolic Syndrome Risk Factors

NCT ID: NCT05001126

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-05-31

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.

Conditions

Metabolic Syndrome; Atherogenic Dyslipidemia; Insulin Resistance; Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HIFT 1x/week

HIFT exercise performed one time per week.

Group Type: EXPERIMENTAL

HIFT 1x/week

Intervention Type: BEHAVIORAL

HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 1x/week represents a dose of one HIFT workout per week.

HIFT 2x/week

HIFT exercise performed two times per week.

Group Type: EXPERIMENTAL

HIFT 2x/week

Intervention Type: BEHAVIORAL

HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 2x/week represents a dose of two HIFT workouts per week.

HIFT 3x/week

HIFT exercise performed three times per week.

Group Type: EXPERIMENTAL

HIFT 3x/week

Intervention Type: BEHAVIORAL

HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 3x/week represents a dose of three HIFT workouts per week.

Interventions

HIFT 1x/week

HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 1x/week represents a dose of one HIFT workout per week.

Intervention Type: BEHAVIORAL

HIFT 2x/week

HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 2x/week represents a dose of two HIFT workouts per week.

Intervention Type: BEHAVIORAL

HIFT 3x/week

HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 3x/week represents a dose of three HIFT workouts per week.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Colorado University

OTHER

Sponsor Role: collaborator

Auckland University of Technology

OTHER

Sponsor Role: collaborator

Gary Van Guilder

OTHER

Sponsor Role: lead

Responsible Party

Gary Van Guilder

Sponsor Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lance C Dalleck, PhD

Role: PRINCIPAL_INVESTIGATOR

Western Colorado University

Nigel Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Auckland University of Technology

Locations

Western Colorado University

Gunnison, Colorado, United States

Countries

United States

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Other Identifiers

WCU_HIFT_MetS

Identifier Type: -

Identifier Source: org_study_id