Personal Activity Intelligence in the Treatment of High Blood Pressure
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Personal Activity Intelligence
Physical Activity Guidelines
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring Hypertension, Exercise Therapy, Blood Pressure Monitoring, Ambulatory, Physical activity monitoring
Eligibility Criteria
Inclusion Criteria:
- Systolic blood pressure (SBP) 130-179 mmHg and/or diastolic blood pressure (DBP) 80-109 mmHg at first clinical visit (screening). Note, this criteria was updated after the inclusion of three participants. The initial inclusion criteria were SBP 140-179 mmHg and/or DBP 90-109 mmHg.
- Not currently engaged in regular physical activity (< 50 PAI per week based on self-reported PA)
Exclusion Criteria:
- Usage of blood pressure medication
- Usage of lipid modifying agents
- Diabetes
- Cardiovascular disease
- Diagnosed secondary hypertension
- Disease or disability that prevent exercise or participation in testing
Sites / Locations
- NTNU Department of Circulation and Medical Imaging
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention
Control
Arm Description
The intervention group is provided with a PA tracker that enables self-monitoring of PA and are instructed to obtain a personalized PA goal on a weekly basis.
The control group is recommended to follow national PA guidelines, which can be considered as the 'intervention' offered to the public.
Outcomes
Primary Outcome Measures
24 hour blood pressure
Change in average systolic and diastolic blood pressure over 24 hours (mmHg). 24h blood pressure is measured automatically 2-3 times per hour with an oscillometric ambulatory blood pressure monitor.
Secondary Outcome Measures
Office blood pressure
Change in average systolic and diastolic blood pressure at clinical visits (mmHg).
Office blood pressure is measured automatically 2-3 times after 5 minutes of rest with an oscillometric blood pressure monitor at an unattended clinical office.
Arterial stiffness
Change in carotid to femoral pulse wave velocity (m/s). Arterial stiffness is measured non-invasive with a validated Pulse Wave Velocity System.
Cardiac function
Change in stroke volume (L/beat). Cardiac function is measured with echocardiography by qualified physician or ultrasound technician .
Cardiorespiratory fitness
Change in maximal oxygen uptake per kg body mass (ml/min/kg). Cardiorespiratory fitness measured directly with cardiopulmonary exercise testing on a treadmill until maximal effort.
Full Information
NCT ID
NCT04151537
First Posted
October 24, 2019
Last Updated
October 12, 2020
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04151537
Brief Title
Personal Activity Intelligence in the Treatment of High Blood Pressure
Official Title
Personal Activity Intelligence (PAI) in the Treatment of High Blood Pressure: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
May 19, 2020 (Actual)
Study Completion Date
May 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Personal Activity Intelligence (PAI) is a novel metric developed to quantify the amount of routine physical activity (PA) needed to improve health and reduce cardiovascular (CV) mortality. The PAI metric can be integrated in PA monitors to promote and track PA. The present pilot study is a 12-week randomized controlled trial designed to test the efficacy of PAI in the treatment of high blood pressure. The primary aim is to investigate how routine PA (expressed as PAI level) affect ambulatory blood pressure by comparing the effect of the intervention (≥100 PAI per week) with a control recommended to follow national PA guidelines. The secondary aims are to investigate the effect on a comprehensive CV risk profile, and to model the effect of PAI level on multiple CV parameters. The CV risk profile includes office BP, arterial stiffness, stroke volume, heart rate, cardiac output, systemic vascular resistance, cardiorespiratory fitness, body composition, blood lipid profile and serum markers of glucose metabolism, kidney failure and systemic inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Hypertension, Exercise Therapy, Blood Pressure Monitoring, Ambulatory, Physical activity monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
The intervention group is provided with a PA tracker that enables self-monitoring of PA and are instructed to obtain a personalized PA goal on a weekly basis.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group is recommended to follow national PA guidelines, which can be considered as the 'intervention' offered to the public.
Intervention Type
Behavioral
Intervention Name(s)
Personal Activity Intelligence
Intervention Description
The intervention group is provided with a PAI monitor (wristband) with a user interface (app) to track their own PAI level and are instructed to obtain at least 100 PAI on a weekly basis.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Guidelines
Intervention Description
The control group is recommended to follow national PA guidelines, meaning 150 minutes of moderate-intensity PA or 75 minutes of vigorous-intensity PA, or a combination there of. The control group is provided with a PAI monitor (wristband) without any user interface and are thus blinded to track their own PAI level.
Primary Outcome Measure Information:
Title
24 hour blood pressure
Description
Change in average systolic and diastolic blood pressure over 24 hours (mmHg). 24h blood pressure is measured automatically 2-3 times per hour with an oscillometric ambulatory blood pressure monitor.
Time Frame
Pre- to postintervention (12 weeks)
Secondary Outcome Measure Information:
Title
Office blood pressure
Description
Change in average systolic and diastolic blood pressure at clinical visits (mmHg).
Office blood pressure is measured automatically 2-3 times after 5 minutes of rest with an oscillometric blood pressure monitor at an unattended clinical office.
Time Frame
Pre- to postintervention (12 weeks)
Title
Arterial stiffness
Description
Change in carotid to femoral pulse wave velocity (m/s). Arterial stiffness is measured non-invasive with a validated Pulse Wave Velocity System.
Time Frame
Pre- to postintervention (12 weeks)
Title
Cardiac function
Description
Change in stroke volume (L/beat). Cardiac function is measured with echocardiography by qualified physician or ultrasound technician .
Time Frame
Pre- to postintervention (12 weeks)
Title
Cardiorespiratory fitness
Description
Change in maximal oxygen uptake per kg body mass (ml/min/kg). Cardiorespiratory fitness measured directly with cardiopulmonary exercise testing on a treadmill until maximal effort.
Time Frame
Pre- to postintervention (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systolic blood pressure (SBP) 130-179 mmHg and/or diastolic blood pressure (DBP) 80-109 mmHg at first clinical visit (screening). Note, this criteria was updated after the inclusion of three participants. The initial inclusion criteria were SBP 140-179 mmHg and/or DBP 90-109 mmHg.
Not currently engaged in regular physical activity (< 50 PAI per week based on self-reported PA)
Exclusion Criteria:
Usage of blood pressure medication
Usage of lipid modifying agents
Diabetes
Cardiovascular disease
Diagnosed secondary hypertension
Disease or disability that prevent exercise or participation in testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Wisløff, PhD
Organizational Affiliation
NTNU, Department of Circulation and Medical Imaging
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Øystein Risa
Organizational Affiliation
NTNU, Department of Circulation and Medical Imaging
Official's Role
Study Director
Facility Information:
Facility Name
NTNU Department of Circulation and Medical Imaging
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27984009
Citation
Nes BM, Gutvik CR, Lavie CJ, Nauman J, Wisloff U. Personalized Activity Intelligence (PAI) for Prevention of Cardiovascular Disease and Promotion of Physical Activity. Am J Med. 2017 Mar;130(3):328-336. doi: 10.1016/j.amjmed.2016.09.031. Epub 2016 Oct 29.
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Personal Activity Intelligence in the Treatment of High Blood Pressure
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