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Trial record 62 of 245 for:    "ottawa heart institute"

Sedentary Intervention Trial in Cardiac Rehabilitation (SIT-CR)

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ClinicalTrials.gov Identifier: NCT02821962
Recruitment Status : Completed
First Posted : July 4, 2016
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
PAL Technologies Ltd.
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: Sedentary prompts from a VTAP device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sedentary Intervention Trial in Cardiac Rehabilitation (SIT-CR): A Randomized Controlled Trial Using the activPAL3™ and activPAL3™ VT to Quantify Free-living Movement Patterns and Reducing Sedentary Time in Cardiac Rehabilitation Patients
Study Start Date : August 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Sedentary prompts from a VTAP device
No Intervention: Usual care
Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.



Primary Outcome Measures :
  1. Feasibility and usability of activPAL3 and VTAP devices [ Time Frame: 9 weeks ]
    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)


Secondary Outcome Measures :
  1. Changes in sedentary time [ Time Frame: 8 weeks ]
    Changes in sedentary time measured by self-report and activPAL3 over 8-week intervention period.


Other Outcome Measures:
  1. Changes in moderate-to-vigorous intensity physical activity [ Time Frame: 8 weeks ]
    Changes in moderate-to-vigorous intensity physical activity (self-reported and as measured by activPAL3)

  2. Changes in body weight [ Time Frame: 8 weeks ]
    Changes in body weight (kg)

  3. Changes in clinical body mass index [ Time Frame: 8 weeks ]
    Changes in BMI (kg/m2)

  4. Changes in waist circumference [ Time Frame: 8 weeks ]
    Changes in waist circumference (cm)

  5. Changes in blood pressure [ Time Frame: 8 weeks ]
    Changes in blood pressure (mmHg)

  6. Changes in resting heart rate [ Time Frame: 8 weeks ]
    Changes in resting heart rate (bpm)

  7. Changes in lipid profile [ Time Frame: 8 weeks ]
    Changes in total cholesterol, HDL, LDL, and triglycerides (mmol/L)

  8. Changes in fasting HbA1c percentage [ Time Frame: 8 weeks ]
    Changes in HbA1c (%)

  9. Changes in anxiety and depression [ Time Frame: 8 weeks ]
    Changes in measures of anxiety and depression as assessed using the Hospital Anxiety and Depression Scale

  10. Changes in health-related quality of life [ Time Frame: 8 weeks ]
    Changes in health-related quality of life as measured by the Short Form-36

  11. Changes in aortic stiffness [ Time Frame: 8 weeks ]
    Changes in aortic stiffness as measured by pulse wave velocity

  12. Changes in maximal aerobic power [ Time Frame: 8 weeks ]
    Changes in maximal aerobic power as assessed using a Modified Bruce Ramp Treadmill Test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is attending on-site (2 times weekly for 8 weeks) cardiac rehabilitation at the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute
  • Patient is 18 years of age or older
  • Patient has confirmed diagnosis of coronary artery disease (CAD)
  • Patient understands English or French
  • Patient is willing and able to provide informed consent

Exclusion Criteria:

  • Patient is unwilling to wear activity monitors
  • Patient is already using a commercial activity monitor with sedentary prompts (e.g. Jump Up, Garmin)
  • Patient is unable to attend follow-up visits
  • Patient not participating in a cardiac rehabilitation program at the University of Ottawa Heart Institute
  • Patient has cognitive impairment (unable to comprehend or participate in the intervention)
  • Patient has a history of postural hypotension
  • Patient is unable, in the opinion of the Medical Director, to participate in the study.

Information from the National Library of Medicine

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): NCT02821962


Locations
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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
PAL Technologies Ltd.
Investigators
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Principal Investigator: Robert D Reid, PhD, MBA Ottawa Heart Institute Research Corporation

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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02821962     History of Changes
Other Study ID Numbers: 20160336
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ottawa Heart Institute Research Corporation:
Sedentary behaviour

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases