Power of Choice on Exercise Adherence and Cardiovascular Health
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| ClinicalTrials.gov Identifier: NCT03576924 |
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Recruitment Status :
Recruiting
First Posted : July 5, 2018
Last Update Posted : October 28, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiorespiratory Fitness | Behavioral: Imposed-MICT Behavioral: Imposed-HIIT Behavioral: CHOICE | Not Applicable |
This trial has been informed by self-determination theory. The theory states that individuals who choose their own activities report increased internal reasons/motivations, as opposed to external reasons (to satisfy another person's suggestions) for the behavior. Internal motivation for performing a behavior are linked with increased pleasure with the behavior and improved adherence.
The primary outcome is improvement in CRF from baseline to 12-months post-intervention. The secondary outcomes are changes in exercise adherence from baseline to 6- and 12-month post-intervention. Tertiary outcomes include self-reported changes in in-task affective responses during the exercise intervention, as well as baseline to 6- and 12-month post-intervention changes in exercise-related motivation and enjoyment in free-living, unsupervised exercise. A total of 201 low active adults (18 to 70 years) with prediabetes will be randomized to a 3-week supervised intervention involving behavioral counseling and one of three exercise conditions, either: 1) imposed high-intensity interval training (Imposed-HIIT; n=67/group); 2) imposed moderate-intensity continuous training (Imposed-MICT), or 3) choice between MICT or HIIT (CHOICE). It is hypothesized that the CHOICE condition will have higher improvements in CRF (primary outcome) from baseline to 12-month post-intervention, and exercise adherence (secondary outcome) from baseline to 6- and 12-months post-intervention, compared to individuals in the IM-MICT or IM-HIIT. For the tertiary outcomes, the CHOICE condition will show greater in-task affective responses during the exercise intervention. We further except greater changes in exercise-related motivation and enjoyment for the CHOICE condition from baseline to 6- and 12-months post-intervention compared to IM-HIIT and IM-MICT conditions. This proposed trial would provide theory- and evidence-based information whether providing choice for engaging in HIIT or MICT is associated with improvements in CRF, exercise adherence, and exercise enjoyment.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 201 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a single-centre, parallel-group randomized controlled trial. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Power of Choice on Exercise Adherence and Cardiovascular Health in Prediabetes |
| Actual Study Start Date : | February 1, 2019 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Imposed-MICT
Continuous exercise for 30 minutes per session at 60-65% of heart rate max for five times per week, consistent with physical activity guidelines that advocate 150 minutes per week of moderate activity.
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Behavioral: Imposed-MICT
Moderate-Intensity Continuous Training (MICT) is continuous exercise for 30 min/session at 60-65% of heart rate max for 5 times/week, consistent with the physical activity guidelines of 150 min/week of moderate activity. Individuals are asked to engage in MICT exercise only (IM-MICT) during the supervised and unsupervised exercise sessions. During the supervised exercise the intensity will be based on the HR monitors, and affective and psychophysiological responses of perceived exertion. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions. |
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Active Comparator: Imposed-HIIT
Five repeated vigorous intervals of 1-min duration at 85-90% of heart rate max with 1-min recovery periods, with 3-min warm-up and 2-min cool-down, making the total session duration 15 min for five times/week, equated to match the guidelines of 75 min of vigorous exercise per week.
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Behavioral: Imposed-HIIT
Individuals randomized to IM-HIIT will be asked to engage in High-Intensity Interval Training (HIIT) exercise only, which is 5 repeated vigorous intervals of 1-min duration at 85-90% of heart rate max with 1-min recovery periods, with 3-min warm-up and 2-min cool-down. Total session duration is 15 min for 5/week and it matches the guidelines of 75 min of vigorous exercise per week. During the supervised and unsupervised exercise sessions participants will perform a 15 min bout of HIIT. During the supervised exercise the intensity will be based on the HR monitors, and affective and psychophysiological responses of perceived exertion. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions. |
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Experimental: CHOICE
Participants will always self-select the exercise type that they will do, either the IM-HIIT or the IM-MICT protocols, which will be matched to the parallel imposed conditions.
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Behavioral: CHOICE
Participants will first be familiarized with HIIT and MICT in randomized, counter-balanced order and subsequently they will always self-select the exercise type for the supervised and unsupervised exercise sessions. The IM-HIIT and IM-MICT protocols will match to the parallel imposed conditions. During the supervised exercise the intensity will also be based on affective and psychophysiological responses of perceived exertion. Throughout the 3-week intervention as well as during the 12-month follow-up, participants in the CHOICE condition will be told to choose either HIIT or MICT each time they exercise. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions. |
- Cardiorespiratory fitness (VO2peak) [ Time Frame: Approximately 12 months: Changes from baseline to 12-month post-intervention ]Cardiorespiratory fitness (VO2peak) will be assessed by a maximal treadmill exercise test using a modified Bruce protocol.
- Exercise adherence [ Time Frame: Approximately 6 and 12 months: Changes from baseline to 6- and 12-month post-intervention. ]Exercise adherence will be objectively measured for 7 consecutive days at baseline, 6-months, and 12-months post-intervention using a tri-axial accelerometer (ActiGraphTM wGT3X-BT, LCC, Fort Walton Beach FL, USA).
- Exercise motivation [ Time Frame: Approximately 6 and 12 months: Changes from baseline to 6- and 12-month post-intervention. ]The Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) will be used to measure exercise-related motivation. The measure assesses amotivation, external, introjected, identified and intrinsic motivation based on the theoretical framework of self-determination theory.
- Exercise enjoyment [ Time Frame: Approximately 6 and 12 months: Changes from baseline to 6- and 12-month post-intervention. ]The Physical Activity Enjoyment Scale (PACES) will be used to assess perceived enjoyment of exercise.
- In-task affective responses [ Time Frame: Changes during the 3-week supervised exercise intervention ]The Feeling Scale (FS) is a single item measure that will be used to assess displeasure-pleasure during supervised exercise training sessions.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI 22-45 kg/m2;
- HbA1c score indicative of prediabetes (5.7-6.4%);
- blood pressure of <160/99 mm Hg assessed according to Canadian Hypertension Education Program guidelines;
- without diagnosed diabetes;
- no prior history of cardiovascular disease;
- not on hormone replacement therapy;
- Cardiovascular medications (e.g., statins) will be allowed if patients are on stable therapy (6 months on same dose)
Exclusion Criteria:
- taking glucose-lowering medications;
- fasting triglycerides ≥5.5 mmol/l;
- any explicit contraindications to exercise (e.g., musculoskeletal injury)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576924
| Contact: Mary E. Jung, PhD | (250) 807-9670 | mary.jung@ubc.ca | |
| Contact: Elena Ivanova, PhD | (514) 553-8216 | elena.ivanova@ubc.ca |
| Canada, British Columbia | |
| University of British Columbia | Recruiting |
| Kelowna, British Columbia, Canada, V1V 1V7 | |
| Contact: Mary E Jung, PhD 2508786891 mary.jung@ubc.ca | |
| Principal Investigator: | Mary E. Jung, PhD | University of British Columbia |
| Responsible Party: | Mary Jung, Associate Professor, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT03576924 |
| Other Study ID Numbers: |
G-18-0022225 |
| First Posted: | July 5, 2018 Key Record Dates |
| Last Update Posted: | October 28, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Physical activity adherence Exercise motivation Exercise enjoyment Prediabetes |