Small Steps for Big Changes

NCT02164474 | Completed

• 1 other identifier: H12-02268
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise is a proven strategy for preventing type 2 diabetes. Traditionally individuals have been prescribed moderate-intensity continuous aerobic exercise but adherence to this standard exercise program is dismal. High-intensity interval training (HIIT) is a novel form of exercise that involves brief, repeated bursts of vigorous exercise separated by periods of recovery. HIIT elicits many favourable cardiometabolic adaptations that are similar to traditional exercise but does so with a lower amount of exercise and in substantially less time than moderate-intensity continuous exercise. Therefore, HIIT has been touted as a "time-efficient" exercise strategy for improving health. Whether overweight individuals at risk for pre diabetes will show greater adherence to HIIT than moderate-intensity continuous exercise over the long-term (12-months) has not been tested. Because exercise adherence requires complex self-regulation, interventions designed to improve adherence should include a behavioural component. The investigators will assess adherence to HIIT and moderate-intensity continuous exercise over 12 months following a short-term (2 week) intervention of either HIIT or moderate-intensity continuous exercise. Both conditions will include a self-regulatory component targeted to increase participants' confidence to engage in regular, independent exercise. The results will help determine whether HIIT is a more feasible option for promoting exercise adherence for pre diabetes prevention than the traditional moderate-intensity continuous exercise. The investigators hypothesize that a) over the 12 months follow-up subjects randomized to the HIIT will be more likely to adhere when compared to moderate-intensity continuous exercise, b) over the 12 months follow-up subjects randomized to HIIT will have higher rates of adherence and levels of total physical activity, c) greater increases in self-regulation (including goal setting, self-monitoring, and self-regulatory efficacy) following HIIT will mediate higher rates of adherence, d) 10-days of HIIT and moderate-intensity continuous exercise will improve cardiorespiratory fitness, increase insulin sensitivity, reduce circulating inflammatory markers, and improve glucose control and e) Improvements in cardiometabolic health factors will be greater following HIIT compared to moderate-intensity continuous exercise.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change from baseline in cardiorespiratory fitness (VO2peak) at 6 and 12-month follow-up

  Changes in cardiorespiratory fitness (VO2peak), an objective measure of fitness and habitual activity, will be used as an integrative measure of exercise adherence (and overall health) at 6-month and 12-month follow-up. Specifically, peak oxygen uptake (VO2peak) will be assessed by a maximal cycling exercise test. Power output will begin at 30 W and increase by 15 W/min until volitional exhaustion. Expired gas samples will be collected continuously and VO2 measured by a metabolic cart (Parvomedics TrueOne 2400). The mean of the two highest 30 s average values will define VO2peak. VO2peak will be confirmed using standard criteria110. A Polar chest strap, which is integrated to the metabolic cart and cycle ergometer (Lode Excalibur), will capture Heart Rate. Peak power output will be recorded as the highest value attained.

  Baseline, 6-month follow-up and 12-month follow-up

Secondary Outcomes (4)

• Self reported adherence to exercise prescription

  Exercise log book filled in for a 12-month duration

• Changes from baseline in objectively measured moderate-to-vigorous physical activity in bouts ≥10 minutes (MVPA10+) at 3-, 6-, 9-, and 12-months follow-up

  Baseline, 3-, 6-, 9-, 12-month follow-up

• Changes in efficacy beliefs

  Baseline, Post-Intervention, 6-, 12-month follow-up

• Changes in body composition

  Baseline, post Intervention, 12-month follow-up

Other Outcomes (5)

• Changes in insulin sensitivity and inflammation

  Baseline, post-intervention, 12-month follow-up

• Changes in acute affect during exercise sessions

  Repeated measurements on Day 1, Day 6 and Day 9 of the intervention

• Changes in exercise enjoyment

  Baseline, post intervention, 6- and 12-month follow-up

Study Arms (2)

High-Intensity Interval Training (HIIT)

EXPERIMENTAL

Participants will perform a series of high-intensity intervals with an interval length of 60-seconds at 90% of peak aerobic capacity workload, and a rest length of 60-seconds.

Behavioral: High-Intensity Interval Training

Moderate-Intensity Continuous Exercise

ACTIVE COMPARATOR

Participants will engage in exercise at 45% of peak aerobic capacity workload.

Behavioral: High-Intensity Interval Training

Interventions

High-Intensity Interval Training BEHAVIORAL

Specifically, individuals randomized to HIIT will begin the intervention with four intervals lasting 1-minute each at \~85-90% peak oxygen uptake \[VO2peak\] and increasing to 10 X 1-min intervals by day 10 of the intervention. Individuals randomized to moderate-intensity exercise condition will begin the intervention with 20 minutes of continuous activity at \~55-60% V02peak and gradually increase the duration to 50 minutes by day 10 of the intervention.

High-Intensity Interval Training (HIIT); Moderate-Intensity Continuous Exercise

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30-65
• Physically inactive (engaging in 2 or less aerobic exercise bouts per week in the last 6 months)
• BMI between 24-40 kg/m2
• Cleared to engage in vigorous exercise (via PARQ+ and, if advised by this validated tool further clearance by their family physician)

You may not qualify if:

• Any contraindications to exercise (e.g., musculoskeletal injury)
• Failure to obtain medical clearance to engage in vigorous intensity exercise following a positive PARQ+ screening
• Prior history of cardio- or cerebrovascular disease or myocardial infarction
• Diagnosed with type 2 diabetes
• Currently taking glucose-lowering medications (e.g., metformin), Hypertension that is not controlled by medication (systolic blood pressure (BP) \>160 mmHg and/or diastolic BP \>99 mmHg)
• Change in cardiovascular medications (e.g., statins) in the previous 6 months Class III obesity (BMI \>40 kg/m2).

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Health and Exercise Psychology Laboratory

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (8)

• Little JP, Safdar A, Wilkin GP, Tarnopolsky MA, Gibala MJ. A practical model of low-volume high-intensity interval training induces mitochondrial biogenesis in human skeletal muscle: potential mechanisms. J Physiol. 2010 Mar 15;588(Pt 6):1011-22. doi: 10.1113/jphysiol.2009.181743. Epub 2010 Jan 25.

  PMID: 20100740 BACKGROUND

• Little JP, Gillen JB, Percival ME, Safdar A, Tarnopolsky MA, Punthakee Z, Jung ME, Gibala MJ. Low-volume high-intensity interval training reduces hyperglycemia and increases muscle mitochondrial capacity in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Dec;111(6):1554-60. doi: 10.1152/japplphysiol.00921.2011. Epub 2011 Aug 25.

  PMID: 21868679 BACKGROUND

• Hood MS, Little JP, Tarnopolsky MA, Myslik F, Gibala MJ. Low-volume interval training improves muscle oxidative capacity in sedentary adults. Med Sci Sports Exerc. 2011 Oct;43(10):1849-56. doi: 10.1249/MSS.0b013e3182199834.

  PMID: 21448086 BACKGROUND

• Trost SG, Owen N, Bauman AE, Sallis JF, Brown W. Correlates of adults' participation in physical activity: review and update. Med Sci Sports Exerc. 2002 Dec;34(12):1996-2001. doi: 10.1097/00005768-200212000-00020.

  PMID: 12471307 BACKGROUND

• Jung ME, Wright WL, Wright AE, Ainslie PN, Little JP. Does the Relationship Between Affect and Exercise Intensity Apply to High-Intensity Interval Exercise? Medicine & Science in Sports & Exercise. 2012;44(5S):85.

  BACKGROUND

• Bourne JE, Little JP, Beauchamp MR, Barry J, Singer J, Jung ME. Brief Exercise Counseling and High-Intensity Interval Training on Physical Activity Adherence and Cardiometabolic Health in Individuals at Risk of Type 2 Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Mar 26;8(3):e11226. doi: 10.2196/11226.

  PMID: 30912761 DERIVED

• Bourne JE, Ivanova E, Gainforth HL, Jung ME. Mapping behavior change techniques to characterize a social cognitive theory informed physical activity intervention for adults at risk of type 2 diabetes mellitus. Transl Behav Med. 2020 Aug 7;10(3):705-715. doi: 10.1093/tbm/ibz008.

  PMID: 30715534 DERIVED

• Barry JC, Simtchouk S, Durrer C, Jung ME, Mui AL, Little JP. Short-term exercise training reduces anti-inflammatory action of interleukin-10 in adults with obesity. Cytokine. 2018 Nov;111:460-469. doi: 10.1016/j.cyto.2018.05.035. Epub 2018 Jun 6.

  PMID: 29885989 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mary E Jung, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

CA (1)