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| Name | Class |
|---|---|
| PAL Technologies Ltd. | OTHER |
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Exercise-based cardiac rehabilitation (CR) has been shown to consistently reduce the rates of total and cardiovascular-related mortality and morbidity. Sedentary behaviours have been shown to be high in patients with cardiovascular disease, but it is not yet known if current CR programming results in significant reductions in these behaviours, or whether a targeted component is warranted. It is also unclear if self-reported sedentary time measures can provide valid and reliable information for monitoring these behaviours in a CR setting, or whether more objective measures are needed. The purpose of this study is to assess the feasibility and usability of the activPAL3 devices for measuring sedentary time in a CR setting, describe changes in sedentary time that occur with standard CR and assess whether the addition of prompting cues from a device can result in further declines in sedentary behaviour and improvements in clinical outcomes, health related quality of life, symptoms of anxiety and depression, aortic stiffness, and aerobic capacity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedentary prompts (VTAP) | Experimental | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes. |
|
| Usual care | No Intervention | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedentary prompts from a VTAP device | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Usability of activPAL3 and VTAP Devices | Primary objective is to assess the feasibility and usability of the activPAL3 and VTAP devices in a CR setting. Assessed by examining acceptability of intervention using evaluation surveys (scores). Reporting on number who reported willingness to wear the monitor again (3+). The scale is a 5-point Likert scale that asks "On a scale from 1 to 5, would you be willing to wear the monitor again?". Response options include: 1(never), 2, 3 (maybe), 4, and 5 (yes, please). | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Sedentary Time | Changes in sedentary time measured by the activPAL3 over 8-week intervention period. Reported as proportion of day spent sedentary. | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Moderate-to-vigorous Intensity Physical Activity | Changes in moderate-to-vigorous intensity physical activity (measured by activPAL3) | baseline and 8 weeks |
| Changes in Body Weight | Changes in body weight (kg) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Reid, PhD, MBA | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedentary Prompts (VTAP) | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes. Sedentary prompts from a VTAP device |
| FG001 | Usual Care | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedentary Prompts (VTAP) | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes. Sedentary prompts from a VTAP device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility and Usability of activPAL3 and VTAP Devices | Primary objective is to assess the feasibility and usability of the activPAL3 and VTAP devices in a CR setting. Assessed by examining acceptability of intervention using evaluation surveys (scores). Reporting on number who reported willingness to wear the monitor again (3+). The scale is a 5-point Likert scale that asks "On a scale from 1 to 5, would you be willing to wear the monitor again?". Response options include: 1(never), 2, 3 (maybe), 4, and 5 (yes, please). | Those who completed and returned the satisfaction surveys. | Posted | Count of Participants | Participants | 9 weeks |
|
9 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedentary Prompts (VTAP) | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes. Sedentary prompts from a VTAP device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Reid | University of Ottawa Heart Institute | 613-696-7393 | breid@ottawaheart.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2016 | Oct 3, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| baseline and 8 weeks |
| Changes in Clinical Body Mass Index | Changes in body mass index (kg/m^2) | baseline and 8 weeks |
| Changes in Waist Circumference | Changes in waist circumference (cm) | baseline and 8 weeks |
| Changes in Systolic Blood Pressure | Changes in systolic blood pressure (mmHg) | baseline and 8 weeks |
| Changes in Resting Heart Rate | Changes in resting heart rate (bpm) | baseline and 8 weeks |
| Changes in Total Cholesterol | Changes in total cholesterol (mmol/L) | baseline and 8 weeks |
| Changes in HbA1c Percentage | Changes in HbA1c percentage | baseline and 8 weeks |
| Changes in Anxiety | Changes in measures of anxiety as assessed using the Hospital Anxiety and Depression Scale. Lower scores mean a better outcome. Score ranges from 0 to 21. | baseline and 8 weeks |
| Changes in Health-related Quality of Life (Physical Component Scale) | Changes in health-related quality of life (Physical Component Scale) as measured by the Short Form-36. Higher scores represent better physical health. Range 0 -100 | baseline and 8 weeks |
| Changes in Pulse Wave Velocity | Changes in pulse wave velocity | baseline and 8 weeks |
| Changes in Maximal Aerobic Power (VO2peak) | Changes in maximal aerobic power as assessed using a Modified Bruce Ramp Treadmill Test | baseline and 8 weeks |
| Change in Health-related Quality of Life (Mental Component Scale) | Change in health-related quality of life (Mental Component Scale) from the SF-36. Higher scores represent better mental health. Range 0 to 100. | baseline and 8 weeks |
| Changes in HDL | Changes in HDL | baseline and 8 weeks |
| Changes in Depression Symptoms as Measured by the Hospital Anxiety and Depression Scale. | Changes in depression symptom score. Lower scores mean a better outcome. Score ranges from 0 to 21. | baseline and 8 weeks |
| BG001 | Usual Care | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Number of cardiac rehabilitation classes attended | Median | Inter-Quartile Range | classes |
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| OG001 | Usual Care | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. |
|
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| Secondary | Changes in Sedentary Time | Changes in sedentary time measured by the activPAL3 over 8-week intervention period. Reported as proportion of day spent sedentary. | Those with complete baseline and post-intervention sedentary time (sitting + lying) measured via activPAL3 | Posted | Mean | Standard Deviation | Percentage of day | baseline and 8 weeks |
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| Other Pre-specified | Changes in Moderate-to-vigorous Intensity Physical Activity | Changes in moderate-to-vigorous intensity physical activity (measured by activPAL3) | Includes participants with complete data on moderate-to-vigorous intensity physical activity from baseline and 8 weeks. | Posted | Mean | Standard Deviation | minutes/day | baseline and 8 weeks |
|
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| Other Pre-specified | Changes in Body Weight | Changes in body weight (kg) | Includes participants with complete data on body weight from baseline and 8 weeks. | Posted | Mean | Standard Deviation | kilograms | baseline and 8 weeks |
|
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| Other Pre-specified | Changes in Clinical Body Mass Index | Changes in body mass index (kg/m^2) | Includes participants with complete data on body mass index from baseline and 8 weeks. | Posted | Mean | Standard Deviation | kilograms per meter squared | baseline and 8 weeks |
|
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| Other Pre-specified | Changes in Waist Circumference | Changes in waist circumference (cm) | Includes participants with complete data on waist circumference from baseline and 8 weeks. | Posted | Mean | Standard Deviation | centimeters | baseline and 8 weeks |
|
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| Other Pre-specified | Changes in Systolic Blood Pressure | Changes in systolic blood pressure (mmHg) | Includes participants with complete data on systolic blood pressure from baseline and 8 weeks. | Posted | Mean | Standard Deviation | mmHg | baseline and 8 weeks |
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| Other Pre-specified | Changes in Resting Heart Rate | Changes in resting heart rate (bpm) | Includes those with complete data on resting heart rate at baseline and 8 weeks | Posted | Mean | Standard Deviation | beats per minute | baseline and 8 weeks |
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| Other Pre-specified | Changes in Total Cholesterol | Changes in total cholesterol (mmol/L) | Includes those with complete data on total cholesterol at baseline and 8 weeks | Posted | Mean | Standard Deviation | mmol/L | baseline and 8 weeks |
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| Other Pre-specified | Changes in HbA1c Percentage | Changes in HbA1c percentage | Includes participants with complete data on HbA1c % from baseline and 8 weeks. | Posted | Mean | Standard Deviation | percentage | baseline and 8 weeks |
|
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| Other Pre-specified | Changes in Anxiety | Changes in measures of anxiety as assessed using the Hospital Anxiety and Depression Scale. Lower scores mean a better outcome. Score ranges from 0 to 21. | Includes participants with complete data on anxiety from the HADS from baseline and 8 weeks. | Posted | Mean | Standard Deviation | score on a scale | baseline and 8 weeks |
|
|
|
| Other Pre-specified | Changes in Health-related Quality of Life (Physical Component Scale) | Changes in health-related quality of life (Physical Component Scale) as measured by the Short Form-36. Higher scores represent better physical health. Range 0 -100 | Includes participants with complete data on quality of life from baseline and 8 weeks. | Posted | Mean | Standard Deviation | score on a scale | baseline and 8 weeks |
|
|
|
| Other Pre-specified | Changes in Pulse Wave Velocity | Changes in pulse wave velocity | Includes participants with complete data on pulse wave velocity from baseline and 8 weeks. | Posted | Mean | Standard Deviation | m/s | baseline and 8 weeks |
|
|
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| Other Pre-specified | Changes in Maximal Aerobic Power (VO2peak) | Changes in maximal aerobic power as assessed using a Modified Bruce Ramp Treadmill Test | Includes participants with complete data on VO2 peak from baseline and 8 weeks. | Posted | Mean | Standard Deviation | mL/kg/min | baseline and 8 weeks |
|
|
|
| Other Pre-specified | Change in Health-related Quality of Life (Mental Component Scale) | Change in health-related quality of life (Mental Component Scale) from the SF-36. Higher scores represent better mental health. Range 0 to 100. | Includes participants with complete data on health-related quality of life from baseline and 8 weeks. | Posted | Mean | Standard Deviation | score on a scale | baseline and 8 weeks |
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| Other Pre-specified | Changes in HDL | Changes in HDL | Includes participants with complete data on HDL from baseline and 8 weeks. | Posted | Mean | Standard Deviation | mmol/L | baseline and 8 weeks |
|
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| Other Pre-specified | Changes in Depression Symptoms as Measured by the Hospital Anxiety and Depression Scale. | Changes in depression symptom score. Lower scores mean a better outcome. Score ranges from 0 to 21. | Includes participants with complete data on depression scores from baseline and 8 weeks. | Posted | Mean | Standard Deviation | score on a scale | baseline and 8 weeks |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Usual Care | Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |