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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL134809 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a 2-arm, 3-month randomized trial comparing a novel sedentary behavior intervention vs. control in working adults (n=271). The primary outcome is resting systolic blood pressure (SBP) at 3 months; secondary outcomes will be resting diastolic blood pressure (DBP), ambulatory blood pressure (ABP), and carotid-femoral pulse wave velocity (cfPWV). Also, best practice objective activity monitoring will be leveraged in the analysis of ABP to account for recent activity and posture and will inform adherence and dose-response relationships.We will also measure plasma renin activity and aldosterone as a potential mechanism of blood pressure reduction, and insulin and glucose as exploratory outcomes.
Hypertension (HTN) is the most common major risk factor for cardiovascular disease (CVD), affecting 1 in 3 American adults. Also, nearly another 1 in 3 adults has prehypertension (preHTN). Moderate-to-vigorous intensity physical activity (MVPA) is known to decrease BP. Guidelines recommend 150 min/week of MVPA performed in continuous bouts of ≥10 min (i.e., bouted MVPA). Sedentary behavior (SED), defined as sitting or reclining with low energy expenditure, has gained attention as a highly prevalent and distinct behavior from MVPA that is independently associated with higher BP, arterial stiffness, CVD, and mortality. These data, coupled with the fact that Americans spend more than half of the waking day in SED, suggest SED as a novel intervention target. Yet, despite heightened public perception of SED as a health risk, there is a dearth of randomized clinical trials demonstrating that SED reduction will lead to health benefits, including reduced BP. Decreasing SED more substantially could improve BP, but this remains unclear in the absence of larger randomized trials with effective SED interventions.
Thus, to test initial efficacy, the Effect of Reducing Sedentary Behavior on Blood Pressure (RESET-BP) has the following specific aims:
Specific aim 1: To evaluate the efficacy of our intervention targeting decreased sedentary behavior (SED) over 3 months. Outcomes include SBP (primary), DBP, ABP (nocturnal, daytime seated, daytime non-seated), and cfPWV. We hypothesize that the 3-month SED intervention will decrease SBP, DBP, ABP and cfPWV vs. controls
Specific Aim 2: To explore whether renin-angiotensin-aldosterone (RAAS) activation (increased plasma renin activity (PRA) and aldosterone) mediates changes in BP elicited by SED reduction
Specific Aim 3: To examine associations between achieved reductions in SED, increases in replacement behaviors (i.e., standing, other light-intensity physical activity (LPA), and BP reduction
These aims will be evaluated with a 2-arm, 3-month randomized trial comparing a novel SED intervention vs. control in 271 adults. The study will recruit adults with untreated, elevated blood pressure (SBP 120-159 mmHg or DBP 80-99 mmHg) and desk jobs that require prolonged SED to maximize the opportunity for SED reduction. The intervention will target currently recommended levels of SED reduction for desk-based employees (2-4 hours/day with frequent postural changes) and will use a behavioral intervention including individual in-person (1/month) and phone counselling (1/month) focused on goal setting, overcoming barriers, self-monitoring, social support, and stimulus control. In addition, the intervention will include environmental modification via provision of a sit-stand desk attachment and external prompting via text messaging and a wrist-worn inactivity prompter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior. |
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| Control | No Intervention | Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Systolic Blood Pressure | Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-minute rest on two occasions | Baseline and Follow-Up (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Diastolic Blood Pressure | Resting diastolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions | Baseline and Follow-Up (3 months) |
| 24-Hour Systolic/Diastolic Ambulatory Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | Glucose will be measure at baseline and 3 month follow-up. | Baseline and Follow-up (3 months) |
| Insulin | Insulin will be measured at baseline and 3 month follow-up. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany Barone Gibbs, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Physical Activity and Weight Management Research Center | Pittsburgh | Pennsylvania | 15216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40165467 | Derived | Holmes AJ, Kline CE, Davis KK, Gordon BD, Stoner L, Quinn TD, Paley JL, Gibbs BB. Comparison of 24-Hour Movement Behaviors in Desk Workers Across Office and Work From Home Locations. J Occup Environ Med. 2025 Jul 1;67(7):e469-e477. doi: 10.1097/JOM.0000000000003380. Epub 2025 Mar 4. | |
| 40011044 | Derived | Quinn TD, Perera S, Conroy MB, Jakicic JM, Muldoon MF, Huber KA, Alansare AB, Holmes AJ, Barone Gibbs B. Impact of sedentary behaviour reduction on desk-worker workplace satisfaction, productivity, mood and health-related quality of life: a randomised trial. Occup Environ Med. 2025 Apr 16;82(2):61-68. doi: 10.1136/oemed-2024-109868. |
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All of the deidentified individual participant data collected during the trial will be shared (including the data dictionary).
Immediately following publication with no planned end date.
Data access will be provided to researchers who provide a methodologically sound proposal.
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271 participants met inclusion criteria and were randomized to either the Sedentary Behavior Reduction Group or the No Contact Control Group. The majority of enrolled participants were excluded due to out of range blood pressure measurements and loss of interest.
Participants were recruited from the vicinity of Pittsburgh, Pennsylvania using a variety of methods (physician's lists, research registries, university automated email blasts, etc.) between November 2017 and November 2022. The first participant was enrolled on January 3, 2018, and the last participant to complete data collection was on November 22, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedentary Behavior Intervention | The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior. |
| FG001 | No Contact Control | Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior. Intervention: The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. Face-to-face intervention lessons occurred in months 1, 2, and 3. Telephone intervention contacts will occur in the 3rd week of months 1-3. |
| 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 | Resting Systolic Blood Pressure | Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-minute rest on two occasions | Systolic Blood Pressure (SBP) | Posted | Mean | Standard Deviation | mm Hg | Baseline and Follow-Up (3 months) |
|
3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
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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 | Intervention | The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior. Intervention: The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising on Arm from ABPM | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bethany Barone Gibbs | West Virginia University | 304-581-1779 | bethany.gibbs@hsc.wvu.edu |
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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 | May 7, 2021 | Nov 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D058246 | Prehypertension |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Outcome assessors will be blinded to the participant group assignment.
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Ambulatory blood pressure will be measured at baseline and 3-month follow-up during a workday and overnight (24 hours total) at the beginning and end of the study |
| Baseline and Follow-Up (3 months) |
| Pulse Wave Velocity | Carotid-femoral and carotid-radial pulse wave velocity will be measured at baseline and follow-up following a 10-min supine rest via tonometry. | Baseline and Follow-Up (3 months) |
| Plasma Renin Activity | Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up. | Baseline and Follow-Up (3 months) |
| Aldosterone | Aldosterone will be measured at baseline and 3 month follow-up. | Baseline and Follow-Up (3 months) |
| Baseline and Follow-Up (3 months) |
| Weight | Weight will be measured by digital scale at baseline and 3 month follow-up. | Baseline and 3 months |
| 39166323 | Derived | Barone Gibbs B, Perera S, Huber KA, Paley JL, Conroy MB, Jakicic JM, Muldoon MF. Effects of Sedentary Behavior Reduction on Blood Pressure in Desk Workers: Results From the RESET-BP Randomized Clinical Trial. Circulation. 2024 Oct 29;150(18):1416-1427. doi: 10.1161/CIRCULATIONAHA.123.068564. Epub 2024 Aug 21. |
| 37130827 | Derived | Alansare AB, Paley JL, Quinn TD, Gibbs BB. Paradoxical Associations of Occupational and Nonoccupational Sedentary Behavior With Cardiovascular Disease Risk Measures in Desk Workers. J Occup Environ Med. 2023 Jul 1;65(7):e506-e513. doi: 10.1097/JOM.0000000000002873. Epub 2023 Apr 30. |
| Physician Decision |
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| Lost to Follow-up |
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| BG001 | Control | Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
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| Secondary | Resting Diastolic Blood Pressure | Resting diastolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions | Posted | Mean | Standard Deviation | mm Hg | Baseline and Follow-Up (3 months) |
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| Secondary | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | Ambulatory blood pressure will be measured at baseline and 3-month follow-up during a workday and overnight (24 hours total) at the beginning and end of the study | Posted | Mean | Standard Deviation | mm Hg | Baseline and Follow-Up (3 months) |
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| Secondary | Pulse Wave Velocity | Carotid-femoral and carotid-radial pulse wave velocity will be measured at baseline and follow-up following a 10-min supine rest via tonometry. | Posted | Mean | Standard Deviation | m/s | Baseline and Follow-Up (3 months) |
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| Secondary | Plasma Renin Activity | Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up. | Participants who had both baseline and follow-up valid blood samples were included. Change descriptive results are reported. | Posted | Mean | Standard Deviation | ng/mL/hr | Baseline and Follow-Up (3 months) |
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| Secondary | Aldosterone | Aldosterone will be measured at baseline and 3 month follow-up. | Participants who had both baseline and follow-up valid blood samples were included. Change descriptive results are reported. | Posted | Mean | Standard Deviation | ng/dL | Baseline and Follow-Up (3 months) |
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| Other Pre-specified | Glucose | Glucose will be measure at baseline and 3 month follow-up. | Participants who had both baseline and follow-up valid blood samples were included. Change descriptive results are reported. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Follow-up (3 months) |
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| Other Pre-specified | Insulin | Insulin will be measured at baseline and 3 month follow-up. | Participants who had both baseline and follow-up valid blood samples were included. Change descriptive results are reported. | Posted | Mean | Standard Deviation | U/mL | Baseline and Follow-Up (3 months) |
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| Other Pre-specified | Weight | Weight will be measured by digital scale at baseline and 3 month follow-up. | Posted | Mean | Standard Deviation | kg | Baseline and 3 months |
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| 0 |
| 136 |
| 4 |
| 136 |
| 32 |
| 136 |
| EG001 | Control | Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment. | 0 | 135 | 4 | 135 | 24 | 135 |
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hospitalization due to diabetes | Endocrine disorders | Systematic Assessment |
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| Grand Mal Seizure | Nervous system disorders | Systematic Assessment |
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| Kidney Stone | Renal and urinary disorders | Systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Arm Pain and Redness from ABPM Cuff | Injury, poisoning and procedural complications | Systematic Assessment |
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| Petechiae from ABPM Measurement | Injury, poisoning and procedural complications | Systematic Assessment |
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| Skin Irritation from Monitor Wear | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Vasovagal Reaction Following Blood Draw | General disorders | Systematic Assessment |
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| Sciatica | Nervous system disorders | Systematic Assessment |
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| Positive COVID-19 Diagnosis | Infections and infestations | Systematic Assessment |
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| Concussion from Object Falling on Head | Injury, poisoning and procedural complications | Systematic Assessment |
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| Started taking disallowed medication (Metformin) | Metabolism and nutrition disorders | Systematic Assessment |
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| Back, Joint, Arthritis Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Eating Disorder | Psychiatric disorders | Systematic Assessment |
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| Planned Surgical Procedures | Surgical and medical procedures | Systematic Assessment |
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| Diabetes Diagnosis | Endocrine disorders | Systematic Assessment |
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| Diverticulitis Event/Diagnosis | Gastrointestinal disorders | Systematic Assessment |
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| Allergic Reaction (difficulty breathing) | Gastrointestinal disorders | Systematic Assessment |
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| Falls and Accidents | Injury, poisoning and procedural complications | Systematic Assessment |
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| Muscle/Tendon Injuries | Injury, poisoning and procedural complications | Systematic Assessment |
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| Traumatic Incident | Social circumstances | Systematic Assessment |
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| Tick Bite | Injury, poisoning and procedural complications | Systematic Assessment |
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| 24-Hour Follow-Up Systolic Blood Pressure |
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| 24-Hour Follow-Up Diastolic Blood Pressure |
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| Follow-up carotid-femoral |
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| Follow-up carotid-radial |
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