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

NCT05001126 | Completed

• 1 other identifier: WCU_HIFT_MetS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Atherogenic Dyslipidemia; Insulin Resistance; Endothelial Dysfunction

Keywords

Exercise

Outcome Measures

Primary Outcomes (14)

• Mean change from baseline and comparison between groups in apolipoprotein B (ApoB) count after 12 weeks of training.

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in the cholesterol content of low-density lipoproteins (LDL-C).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in the cholesterol content of very low-density lipoproteins (VLDL-C).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in the cholesterol content of high-density lipoproteins (HDL-C).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in the total cholesterol (TC) content of all lipoproteins.

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in the triglyceride content of LDL (LDL-T).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in the triglyceride content of VLDL (VLDL-T).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in the total triglyceride content of all lipoprotein classes (TG).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in blood glucose (BG).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in blood insulin (INS).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in the Homeostatic Assessment of Insulin Resistance (HOMA-IR).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups in glycosylated hemoglobin (HbA1c) after 12 weeks of training.

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups of endothelial-dependent peak blood flow (PBF).

  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.

  Baseline and 48hrs post 12-week training completion

• Mean change from baseline and comparison between groups of endothelial-dependent area under the curve (AUC) of hyperemia blood flow.

  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.

  Baseline and 48hrs post 12-week training completion

Secondary Outcomes (4)

• 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 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 self-perceived fitness after 12 weeks of training.

  Baseline and 48hrs post 12-week training completion

Other Outcomes (2)

• Comparison between groups of exercise enjoyment perception after 12 weeks of training.

  24hrs post 12-week training completion

• Comparison between groups of the intention to continue their allocated intervention after 12 weeks of training.

  24hrs post 12-week training completion

Study Arms (3)

HIFT 1x/week

EXPERIMENTAL

HIFT exercise performed one time per week.

Behavioral: HIFT 1x/week

HIFT 2x/week

EXPERIMENTAL

HIFT exercise performed two times per week.

Behavioral: HIFT 2x/week

HIFT 3x/week

EXPERIMENTAL

HIFT exercise performed three times per week.

Behavioral: HIFT 3x/week

Interventions

HIFT 1x/week 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 1x/week

HIFT 2x/week 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 2x/week

HIFT 3x/week 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.

HIFT 3x/week

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gary Van Guilder: lead
• Western Colorado University: collaborator
• Auckland University of Technology: collaborator

Study Sites (1)

Western Colorado University

Gunnison, Colorado, 81230, United States

Location

Related Publications (12)

• Sarafidis PA, Lasaridis AN, Nilsson PM, Pikilidou MI, Stafilas PC, Kanaki A, Kazakos K, Yovos J, Bakris GL. Validity and reproducibility of HOMA-IR, 1/HOMA-IR, QUICKI and McAuley's indices in patients with hypertension and type II diabetes. J Hum Hypertens. 2007 Sep;21(9):709-16. doi: 10.1038/sj.jhh.1002201. Epub 2007 Apr 19.

  PMID: 17443211 BACKGROUND

• Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.

  PMID: 3899825 BACKGROUND

• Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.

  PMID: 21441238 BACKGROUND

• Merellano-Navarro E, Collado-Mateo D, Garcia-Rubio J, Gusi N, Olivares PR. Validity of the International Fitness Scale "IFIS" in older adults. Exp Gerontol. 2017 Sep;95:77-81. doi: 10.1016/j.exger.2017.05.001. Epub 2017 May 2.

  PMID: 28476584 BACKGROUND

• BALKE B, WARE RW. The present status of physical fitness in the Air Force. Proj Rep USAF Sch Aviat Med. 1959 May;59(67):1-9. No abstract available.

  PMID: 24546008 BACKGROUND

• Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6.

  PMID: 19199208 BACKGROUND

• Nolan PB, Beaven ML, Dalleck L. Comparison of intensities and rest periods for VO2max verification testing procedures. Int J Sports Med. 2014 Nov;35(12):1024-9. doi: 10.1055/s-0034-1367065. Epub 2014 Jun 2.

  PMID: 24886925 BACKGROUND

• Weatherwax RM, Richardson TB, Beltz NM, Nolan PB, Dalleck L. Verification Testing to Confirm VO2max in Altitude-Residing, Endurance-Trained Runners. Int J Sports Med. 2016 Jun;37(7):525-30. doi: 10.1055/s-0035-1569346. Epub 2016 Apr 29.

  PMID: 27128112 BACKGROUND

• Kendzierski D and DeCarlo KJ. Physical activity enjoyment scale: Two validation studies. Journal of Sport and Exercise Psychology. 1991; 13:50-64.

  BACKGROUND

• Kwan BM, Bryan A. In-task and post-task affective response to exercise: translating exercise intentions into behaviour. Br J Health Psychol. 2010 Feb;15(Pt 1):115-31. doi: 10.1348/135910709X433267. Epub 2009 Apr 25.

  PMID: 19397847 BACKGROUND

• Heinrich KM, Crawford DA, Johns BR, Frye J, and Gilmore KEO. Affective responses during high-intensity functional training compared to high-intensity interval training and moderate continuous training. Sport, Exercise, and Performance Psychology. 2019;9(1):115-127.

  BACKGROUND

• Smith LE, Van Guilder GP, Dalleck LC, Harris NK. The effects of high-intensity functional training on cardiometabolic risk factors and exercise enjoyment in men and women with metabolic syndrome: study protocol for a randomized, 12-week, dose-response trial. Trials. 2022 Mar 1;23(1):182. doi: 10.1186/s13063-022-06100-7.

  PMID: 35232475 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Motor Activity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Lance C Dalleck, PhD

  Western Colorado University

  PRINCIPAL INVESTIGATOR

• Nigel Harris, PhD

  Auckland University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Primary investigator will be blinded from each participant's dose allocation.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Model Details: Three dose groups

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 11, 2021
• Study Start: September 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available indefinitely upon completion of trail and statistical analysis.
• Access Criteria: Data will be available upon request via email to principle investigator.

Locations

US (1)