High-intensity exercise to promote accelerated improvements in cardiorespiratory fitness (HI-PACE): study protocol for a randomized controlled trial

Joshua E McGee, Savanna G Barefoot, Nicole R Gniewek, Patricia M Brophy, Angela Clark, Gabriel S Dubis, Terence E Ryan, Joseph A Houmard, Paul Vos, Thomas D Raedeke, Damon L Swift, Joshua E McGee, Savanna G Barefoot, Nicole R Gniewek, Patricia M Brophy, Angela Clark, Gabriel S Dubis, Terence E Ryan, Joseph A Houmard, Paul Vos, Thomas D Raedeke, Damon L Swift

Abstract

Background: African Americans have a disproportionate prevalence and incidence of type 2 diabetes compared with Caucasians. Recent evidence indicates that low cardiorespiratory fitness (CRF) level, an independent risk factor for type 2 diabetes, is also more prevalent in African Americans than Caucasians. Numerous studies in Caucasian populations suggest that vigorous exercise intensity may promote greater improvements in CRF and other type 2 diabetes risk factors (e.g., reduction of glucose/insulin levels, pulse wave velocity, and body fat) than moderate intensity. However, current evidence comparing health benefits of different aerobic exercise intensities on type 2 diabetes risk factors in African Americans is negligible. This is clinically important as African Americans have a greater risk for type 2 diabetes and are less likely to meet public health recommendations for physical activity than Caucasians. The purpose of the HI-PACE (High-Intensity exercise to Promote Accelerated improvements in CardiorEspiratory fitness) study is to evaluate whether high-intensity aerobic exercise elicits greater improvements in CRF, insulin action, and arterial stiffness than moderate-intensity exercise in African Americans.

Methods/design: A randomized controlled trial will be performed on overweight and obese (body mass index of 25-45 kg/m2) African Americans (35-65 years) (n = 60). Participants will be randomly assigned to moderate-intensity (MOD-INT) or high-intensity (HIGH-INT) aerobic exercise training or a non-exercise control group (CON) for 24 weeks. Supervised exercise will be performed at a heart rate associated with 45-55% and 70-80% of VO2 max in the MOD-INT and HIGH-INT groups, respectively, for an exercise dose of 600 metabolic equivalents of task (MET)-minutes per week (consistent with public health recommendations). The primary outcome is change in CRF. Secondary outcomes include change in insulin sensitivity (measured via an intravenous glucose tolerance test), skeletal muscle mitochondrial oxidative capacity (via near-infrared spectroscopy), skeletal muscle measurements (i.e., citrate synthase, COX IV, GLUT-4, CPT-1, and PGC1-α), arterial stiffness (via carotid-femoral pulse wave velocity), body fat, C-reactive protein, and psychological outcomes (quality of life/exercise enjoyment).

Discussion: The anticipated results of the HI-PACE study will provide vital information on the health effects of high-intensity exercise in African Americans. This study will advance health disparity research and has the potential to influence future public health guidelines for physical activity.

Trial registration: ClinicalTrials.gov identifier: NCT02892331 . Registered on September 8, 2016.

Keywords: African American; Arterial stiffness; Cardiorespiratory fitness; Exercise intensity; Insulin sensitivity; Methodology.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of study visits in the HI-PACE (High-Intensity exercise to Promote Accelerated improvements in CardiorEspiratory fitness) study
Fig. 2
Fig. 2
Study schedule of enrollment, intervention, and assessments. Abbreviations: AIx augmentation index, CON non-exercise control group, DEXA dual-energy x-ray absorptiometry, FFQ food frequency questionnaire, HIGH-INT high-intensity exercise group, IVGTT intravenous glucose tolerance test, MOD-INT moderate-intensity exercise group, NIRS near-infrared spectroscopy, PA physical activity, PWV pulse wave velocity, SF-36 short-form health survey, t1 baseline, t2 mid-intervention (week 12), t3 follow-up (week 24)
Fig. 3
Fig. 3
Ramping protocol of required MET-minutes in both the MOD-INT and HIGH-INT groups in the HI-PACE study. Abbreviations: HIGH-INT high-intensity exercise group, HI-PACE High-Intensity exercise to Promote Accelerated improvements in CardiorEspiratory fitness, MET Metabolic equivalents of task, MOD-INT moderate-intensity exercise group

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