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Completed

NCT Number: NCT02821962

Sedentary Intervention Trial in Cardiac Rehabilitation

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sedentary prompts from a VTAP device

Behavioral

Primary outcomes

  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). 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).

Secondary outcomes

  1. Changes in Sedentary Time

    Time frame: baseline and 8 weeks

    Changes in sedentary time measured by the activPAL3 over 8-week intervention period. Reported as proportion of day spent sedentary.

Other outcomes

  1. Changes in Moderate-to-vigorous Intensity Physical Activity

    Time frame: baseline and 8 weeks

    Changes in moderate-to-vigorous intensity physical activity (measured by activPAL3)

  2. Changes in Body Weight

    Time frame: baseline and 8 weeks

    Changes in body weight (kg)

  3. Changes in Clinical Body Mass Index

    Time frame: baseline and 8 weeks

    Changes in body mass index (kg/m^2)

  4. Changes in Waist Circumference

    Time frame: baseline and 8 weeks

    Changes in waist circumference (cm)

  5. Changes in Systolic Blood Pressure

    Time frame: baseline and 8 weeks

    Changes in systolic blood pressure (mmHg)

  6. Changes in Resting Heart Rate

    Time frame: baseline and 8 weeks

    Changes in resting heart rate (bpm)

  7. Changes in Total Cholesterol

    Time frame: baseline and 8 weeks

    Changes in total cholesterol (mmol/L)

  8. Changes in HbA1c Percentage

    Time frame: baseline and 8 weeks

    Changes in HbA1c percentage

  9. Changes in Anxiety

    Time frame: baseline and 8 weeks

    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.

  10. Changes in Health-related Quality of Life (Physical Component Scale)

    Time frame: baseline and 8 weeks

    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

  11. Changes in Pulse Wave Velocity

    Time frame: baseline and 8 weeks

    Changes in pulse wave velocity

  12. Changes in Maximal Aerobic Power (VO2peak)

    Time frame: baseline and 8 weeks

    Changes in maximal aerobic power as assessed using a Modified Bruce Ramp Treadmill Test

  13. Change in Health-related Quality of Life (Mental Component Scale)

    Time frame: baseline and 8 weeks

    Change in health-related quality of life (Mental Component Scale) from the SF-36. Higher scores represent better mental health. Range 0 to 100.

  14. Changes in HDL

    Time frame: baseline and 8 weeks

    Changes in HDL

  15. Changes in Depression Symptoms as Measured by the Hospital Anxiety and Depression Scale.

    Time frame: baseline and 8 weeks

    Changes in depression symptom score. Lower scores mean a better outcome. Score ranges from 0 to 21.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • PAL Technologies Ltd.

Registry information

Official study 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

Acronym: SIT-CR

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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