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Small Steps for Big Changes

15 marzo 2017 aggiornato da: University of British Columbia

Time-efficient High-intensity Interval Training Versus Moderate-intensity Continuous Aerobic Training for Promoting Exercise Adherence: A Randomized-controlled Trial

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1V7
        • Health and Exercise Psychology Laboratory

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 30 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: Moderate-Intensity Continuous Exercise
Participants will engage in exercise at 45% of peak aerobic capacity workload.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in cardiorespiratory fitness (VO2peak) at 6 and 12-month follow-up
Lasso di tempo: Baseline, 6-month follow-up 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self reported adherence to exercise prescription
Lasso di tempo: Exercise log book filled in for a 12-month duration
Self-reported adherence will be measuring using an online exercise log book, which participants will be asked to fill in following each exercise session. Adherence will be measured using raw exercise prescription bouts completed. Proportion achieved based on the amount prescription will also be calculated.
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
Lasso di tempo: Baseline, 3-, 6-, 9-, 12-month follow-up
Changes in total time spent in moderate-to-vigorous physical activity in bouts ≥10 minutes (MVPA10+) will be assessed over 7 days using tri-axial accelerometers at baseline and 3, 6-, 9- and 12-month follow-up.
Baseline, 3-, 6-, 9-, 12-month follow-up
Changes in efficacy beliefs
Lasso di tempo: Baseline, Post-Intervention, 6-, 12-month follow-up
Changes in participants exercise efficacy beliefs, self-regulatory efficacy beliefs, concurrent self-regulatory efficacy beliefs, and self-monitoring efficacy beliefs will be measured at baseline, post-intervention, 6-month follow-up and 12-month follow-up. Efficacy measures will be context specific and will utilize a confidence scale ranging from 0%-100%.
Baseline, Post-Intervention, 6-, 12-month follow-up
Changes in body composition
Lasso di tempo: Baseline, post Intervention, 12-month follow-up
Body composition will be assessed using the Hologic Discovery A device. DXA is a standard tool in the measurement of body composition and bone density in adults and children throughout multiple institutions.
Baseline, post Intervention, 12-month follow-up

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in insulin sensitivity and inflammation
Lasso di tempo: Baseline, post-intervention, 12-month follow-up
Changes in insulin sensitivity and inflammation will be examined. Specifically fasting blooding samples will be taken to assess markers of insulin sensitivity (glucose, insulin, HOMA-IR) and inflammation (C-reactive protein [CRP], interleukin [IL]-6, tumor necrosis factor [TNF]-alpha).
Baseline, post-intervention, 12-month follow-up
Changes in acute affect during exercise sessions
Lasso di tempo: Repeated measurements on Day 1, Day 6 and Day 9 of the intervention
The acute affective response to exercise will be assessed using the 1-item Feeling Scale (FS). The FS is the most frequently used measure of in-task exercise feelings of pleasure/displeasure. Consistent with our established laboratory protocol for assessing and comparing affect in intermittent and continuous exercise bouts, feeling scale will be assessed immediately pre- and post-exercise, and at the beginning (2.5%), middle (42.5%), and end (92.5%) of workout completion. These time points correspond to the midpoint of the first, fifth, and tenth interval within the HIIT protocol. Measurements of affect will be taken in Day 1, Day 6 and Day 9 of the 10-day intervention.
Repeated measurements on Day 1, Day 6 and Day 9 of the intervention
Changes in exercise enjoyment
Lasso di tempo: Baseline, post intervention, 6- and 12-month follow-up
The Physical Activity Enjoyment Scale (PACES) will be used to assess perceived enjoyment at baseline and post intervention. This 18-item measure is scored on a 7-point bipolar scale based on the instruction; "Please rate how you feel at the moment about the physical activity you have been doing:". Example items are "it's not very refreshing/It's very refreshing" and "I would rather be doing something else/there is nothing else I would rather be doing". Items are summed to produce an overall enjoyment score out of 126.
Baseline, post intervention, 6- and 12-month follow-up
Changes from baseline in average blood glucose at day 9 of the intervention
Lasso di tempo: Baseline, Intervention day 9
Changes in average blood glucose from baseline to day 9 of the intervention will be measured using the CGMS iPro2 (Medtronic, Northridge, CA). The CGM records glucose values in a blinded fashion using a small microneedle inserted into the subcutaneous abdominal adipose tissue that is connected to a recorder that quantifies interstitial glucose values every 5 minutes for up to three days. Finger stick blood glucose samples, taken four times per day, are used as calibrators to create a 24-hr blood glucose curve, which are downloaded upon device removal and analyzed for: i) average blood glucose, ii) 2 hr postprandial area under the glucose curve, iii) post-meal spikes, and iv) overall glycemic stability. Participants wearing the CGM will be provided a standardized diet (~24 kcal/kg, 60% carbohydrates, 27% fat, 13% protein) to consume during each 24 hr monitoring period. CGM data will be collected at baseline and day 9 of training.
Baseline, Intervention day 9
Change in Affective and Instrumental Attitudes
Lasso di tempo: Baseline, intervention day 6, post-intervention, 12-month follow-up
Affective attitudes towards physical activity will be assessed using the procedures outlined by Ajzen (2002). Specifically, a 7-point semantic differential scale will be used, with anchors including "Enjoyable-Unenjoyable", "Pleasant-Unpleasant", "Interesting-Boring". Previous research has found support for both the internal consistency and predictive utility of scores derived from this instrument.
Baseline, intervention day 6, post-intervention, 12-month follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of British Columbia

Collaboratori

Canadian Institutes of Health Research (CIHR)

Investigatori

  • Investigatore principale: Mary E Jung, PhD, University of British Columbia

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2014

Completamento primario (Effettivo)

1 febbraio 2017

Completamento dello studio (Effettivo)

1 febbraio 2017

Date di iscrizione allo studio

Primo inviato

12 giugno 2014

Primo inviato che soddisfa i criteri di controllo qualità

13 giugno 2014

Primo Inserito (Stima)

16 giugno 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • H12-02268

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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