Small Steps for Big Changes

NCT ID: NCT02164474

Last Updated: 2017-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Eligible participants will be randomized to the HIIT or moderate-intensity continuous exercise conditions. Each condition will involve a two-week supervised exercise period consisting of ten sessions. Exercise prescriptions for each condition will be progressive in nature over the two week supervised period and will be matched for external work. Specifically, individuals randomized to HIIT will begin with four intervals lasting 1-minute each at \~85-90% peak oxygen uptake \[VO2peak\] and increased to 10 X 1-min intervals by day 10. Individuals randomized to moderate-intensity exercise condition will begin with 20 minutes of continuous activity at \~55-60% V02peak and gradually increase the duration to 50 minutes by day 10. Participants will self-select exercise modality (walking outdoors, elliptical machine, treadmill walking, or stationary cycling). One trainer will supervise participants during the 2-week training program. Participants will complete 3 of the 10 training days (day 4, 7 and 9) at home unsupervised. Participants will wear a heart rate monitor during each exercise session (supervised and unsupervised) to monitor exercise intensity and ensure compliance. In addition, participants will record their exercise bouts in a logbook on both lab and home training days.

Participants in both conditions received 10 minutes of behavioural counseling each day they trained in the lab (for a total of 70 minutes). Following the supervised training, participants will be instructed to maintain HIIT or moderate-intensity continuous exercise three days per week independently. Specifically, individuals randomized to HIIT will be prescribed three exercise sessions per week involving 10 X 1-minute intervals at \~85-90% VO2peak, while participants randomized to moderate-intensity continuous exercise will be prescribed three session per week of 50-minute continuous exercise at \~55-60% VO2peak. Training logs will be provided and participants will be instructed to estimate exercise intensity based on physiological cues taught during supervised training days.

Conditions

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Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High-Intensity Interval Training (HIIT)

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.

Group Type EXPERIMENTAL

High-Intensity Interval Training

Intervention Type 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.

Moderate-Intensity Continuous Exercise

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

Group Type ACTIVE_COMPARATOR

High-Intensity Interval Training

Intervention Type 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.

Interventions

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High-Intensity Interval Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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).
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary E Jung, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Health and Exercise Psychology Laboratory

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 20100740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21868679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21448086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12471307 (View on PubMed)

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.

Reference Type 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.

Reference Type DERIVED
PMID: 30912761 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30715534 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29885989 (View on PubMed)

Other Identifiers

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H12-02268

Identifier Type: -

Identifier Source: org_study_id

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