Studies
| Study First Submitted Date | 2019-10-24 |
| Study First Posted Date | 2019-11-05 |
| Last Update Posted Date | 2020-10-19 |
| Start Month Year | October 21, 2019 |
| Primary Completion Month Year | May 19, 2020 |
| Verification Month Year | October 2020 |
| Verification Date | 2020-10-31 |
| Last Update Posted Date | 2020-10-19 |
Facilities
| Sequence: | 199625271 |
| Name | NTNU Department of Circulation and Medical Imaging |
| City | Trondheim |
| Country | Norway |
Conditions
| Sequence: | 52067191 |
| Name | Essential Hypertension |
| Downcase Name | essential hypertension |
Id Information
| Sequence: | 40075981 |
| Id Source | org_study_id |
| Id Value | 2019/1084 |
Countries
| Sequence: | 42473879 |
| Name | Norway |
| Removed | False |
Design Groups
| Sequence: | 55479180 | Sequence: | 55479181 |
| Group Type | Active Comparator | Group Type | Active Comparator |
| Title | Intervention | Title | Control |
| 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. | Description | The control group is recommended to follow national PA guidelines, which can be considered as the ‘intervention’ offered to the public. |
Interventions
| Sequence: | 52379656 | Sequence: | 52379657 |
| Intervention Type | Behavioral | Intervention Type | Behavioral |
| Name | Personal Activity Intelligence | Name | Physical Activity Guidelines |
| 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. | 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. |
Keywords
| Sequence: | 79697324 | Sequence: | 79697325 | Sequence: | 79697326 | Sequence: | 79697327 |
| Name | Hypertension | Name | Exercise Therapy | Name | Blood Pressure Monitoring, Ambulatory | Name | Physical activity monitoring |
| Downcase Name | hypertension | Downcase Name | exercise therapy | Downcase Name | blood pressure monitoring, ambulatory | Downcase Name | physical activity monitoring |
Design Outcomes
| Sequence: | 177020619 | Sequence: | 177020620 | Sequence: | 177020621 | Sequence: | 177020622 | Sequence: | 177020623 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | 24 hour blood pressure | Measure | Office blood pressure | Measure | Arterial stiffness | Measure | Cardiac function | Measure | Cardiorespiratory fitness |
| Time Frame | Pre- to postintervention (12 weeks) | Time Frame | Pre- to postintervention (12 weeks) | Time Frame | Pre- to postintervention (12 weeks) | Time Frame | Pre- to postintervention (12 weeks) | Time Frame | Pre- to postintervention (12 weeks) |
| 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. | 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. |
Description | Change in carotid to femoral pulse wave velocity (m/s). Arterial stiffness is measured non-invasive with a validated Pulse Wave Velocity System. | Description | Change in stroke volume (L/beat). Cardiac function is measured with echocardiography by qualified physician or ultrasound technician . | 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. |
Browse Conditions
| Sequence: | 193071752 | Sequence: | 193071753 | Sequence: | 193071754 | Sequence: | 193071755 |
| Mesh Term | Hypertension | Mesh Term | Essential Hypertension | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
| Downcase Mesh Term | hypertension | Downcase Mesh Term | essential hypertension | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48222756 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Norwegian University of Science and Technology |
Overall Officials
| Sequence: | 29224529 | Sequence: | 29224530 |
| Role | Principal Investigator | Role | Study Director |
| Name | Ulrik Wisløff, PhD | Name | Øystein Risa |
| Affiliation | NTNU, Department of Circulation and Medical Imaging | Affiliation | NTNU, Department of Circulation and Medical Imaging |
Design Group Interventions
| Sequence: | 68010276 | Sequence: | 68010277 |
| Design Group Id | 55479180 | Design Group Id | 55479181 |
| Intervention Id | 52379656 | Intervention Id | 52379657 |
Eligibilities
| Sequence: | 30704657 |
| Gender | All |
| Minimum Age | 45 Years |
| Maximum Age | 64 Years |
| Healthy Volunteers | Accepts Healthy Volunteers |
| 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. Exclusion Criteria: Usage of blood pressure medication |
| Adult | True |
| Child | False |
| Older Adult | False |
Calculated Values
| Sequence: | 253923322 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2019 |
| Actual Duration | 7 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 45 |
| Maximum Age Num | 64 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 4 |
Designs
| Sequence: | 30451277 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28817747 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 51961355 |
| Pmid | 27984009 |
| Reference Type | background |
| 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. |