A MOST Framework Trial Evaluating the MOst effectiVe Exercise Types for Blood Pressure Control (MOVE-BP)
Exercise is known to prevent nearly one in three cases of hypertension and slow its progression in young adults, but we do not know which specific exercise types are most effective. The main objective of this study is to determine which exercise prescription (ExRx) intervention component(s) alone or in combination most effectively lower systolic BP in young adults with stage I hypertension, identify the vascular mechanisms underlying these changes, and guide the development of optimized exercise-based prescription packages for effective hypertension control in this population.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Nearly one-third of hypertension cases are preventable through exercise alone. Yet among the more than 30 million U.S young adults with stage I hypertension, fewer than 10% achieve BP control, and up to half progress to stage II within five years. While moderate-to-vigorous intensity aerobic training (AT) is first-line therapy, up to 40% of individuals, especially those with stage I hypertension, show little or no benefit. Current guidelines continue to emphasize generic AT prescriptions, overlooking physiological variability that may influence exercise effectiveness. Resistance training (RT), including dynamic (DRT) and isometric (IRT) types, is also guideline recommended for managing hypertension, and can lower systolic BP as much as-or even more than AT. Notably, DRT and IRT engage different physiological pathways-systemic vs. localized vascular adaptations-suggesting their BP effects may differ. However, most exercise trials for hypertension test exercise types (components) in isolation or as bundles (e.g., AT + RT) without systematically evaluating which components drive BP reduction. This leaves critical gaps in understanding which exercise components or combinations thereof are most effective, and by what mechanisms. A component-specific approach is necessary to move toward a more tailored, effective exercise treatment strategy for stage I hypertension. This proposed study (MOVE-BP) uses a Multiphase Optimization Strategy (MOST) framework with a 2^3 factorial experiment to efficiently test individual and combined exercise components (AT, DRT, and IRT) in unmedicated young adults with Stage I hypertension. The goal is to identify which components meaningfully contribute to systolic BP reduction and guide the development of optimized exercise-based prescription packages for effective hypertension control in this population. This study is designed as Bi-Phasic Project: the first year will be dedicated to finalizing protocols, establishing trial infrastructure, and enroll the first participant(s) to facilitate transition to the full-scale trial. In subsequent years (year 2-5), a total of 264 adults aged 18-44 years eligible for lifestyle therapy only will be enrolled and will receive a core intervention (Fitbit + standard BP health education) and be randomized into one of eight remotely delivered conditions, with each testing AT, DRT, and IRT alone or across all possible combinations. Aim 1 will identify which exercise components or combinations most effectively reduce systolic BP at 6 months, with follow-up at 12 months to evaluate maintenance of BP effects and exercise adherence. Aim 2 will examine whether improvement in arterial stiffness, endothelial function, and carotid artery distensibility mediate BP change, and whether individual-characteristics (age, sex, race, body weight, diet quality) moderate exercise component effects. This study will generate critical evidence to inform the development of optimized, scalable exercise treatment packages for hypertension control and long-term cardiovascular disease prevention in young adults.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Mandy Pershing, MS
- Telefonní číslo: 312-503-3237
- E-mail: mandy.pershing@northwestern.edu
Studijní místa
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60611
- Northwestern University
-
Kontakt:
- Mandy Pershing, MS
- Telefonní číslo: 312-503-3237
- E-mail: mandy.pershing@northwestern.edu
-
Vrchní vyšetřovatel:
- Deepika Laddu, PhD
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Age 18-44 years Northwestern University patient with untreated Stage I hypertension (blood pressure 130-139/80-89 mmHg) documented on at least 2 outpatient encounters in the prior year No current antihypertensive medication use Estimated 10-year cardiovascular disease risk below 7.5% by the PREVENT risk calculator Body mass index 18.5-39.9 kg/m² Average home blood pressure of 130-139/80-89 mmHg during a 7-day home monitoring period Fewer than 150 minutes per week of moderate-to-vigorous physical activity measured by accelerometer Exercise readiness confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+), with medical clearance if indicated English fluency Reliable internet access on a computer, smartphone, or tablet, with videoconference capability (e.g., Zoom)
Exclusion Criteria:
Use of a GLP-1 receptor agonist within the past year Weight change of more than 15 lbs in the prior 3 months Pregnant or planning to become pregnant within 6 months Active cancer and/or currently receiving cancer treatment History of type 1 or type 2 diabetes History of chronic kidney disease History of chronic obstructive pulmonary disease History of cardiovascular disease or coronary heart disease Absolute contraindication to exercise (e.g., severe neurological, psychological, or orthopedic condition)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Core + AT + DRT + IRT
Participants receive the core intervention (Fitbit activity tracker and standard blood pressure health education) plus all three exercise components for 6 months: aerobic training (AT), dynamic resistance training (DRT), and isometric resistance training (IRT). AT: 4 sessions/week of moderate-to-vigorous endurance exercise, progressing from 40-59% to 60-89% heart rate reserve. DRT: 3 sessions/week of 6 exercises, 3 sets each, progressing from 50% to 70-80% of 1-repetition maximum. IRT: 3 sessions/week of a 3-exercise circuit, 4 sets of holds progressing to 2 minutes, at 30% maximum voluntary contraction (upper body) and 95% peak heart rate (lower body). Each component includes 1 trainer-supervised videoconference session per week; remaining sessions are unsupervised and guided by manualized videos. |
All participants receive a wrist-worn Fitbit activity tracker (Charge 3 or similar) to wear daily during waking hours, synced to a secure coaching portal that study staff use to monitor wear adherence. Participants also receive standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) by email or mail twice per month for 6 months. Topics include hypertension and its health risks, BP self-monitoring, healthy eating, and active lifestyle strategies. Materials are non-interactive and standardized across all conditions. Arms: 1, 2, 3, 4, 5, 6, 7, 8 6-month remotely delivered endurance-based exercise program (e.g., walking, stair climbing) performed 4 sessions per week at moderate-to-vigorous intensity. Intensity begins at 40-59% heart rate reserve and progresses to 60-89% heart rate reserve, guided by 6-minute walk tests at baseline, 3 months, and 6 months. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Intensity is monitored by Fitbit heart rate and rating of perceived exertion. Arms: 1, 2, 3, 4 6-month remotely delivered resistance exercise program performed 3 sessions per week, consisting of 6 multi-joint, single-joint, and trunk exercises (e.g., squat, chest press, lunges, shoulder press), 3 sets each. Intensity begins at 50% of 1-repetition maximum and progresses to 70-80% of 1-repetition maximum by 6 months using overload principles, with 1-repetition maximum retested at 3 and 6 months. Participants receive an adjustable dumbbell set. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Sets, repetitions, and load are logged in the coaching portal. Arms: 1, 2, 5, 6 6-month remotely delivered isometric exercise program performed 3 sessions per week, consisting of a 3-exercise circuit (e.g., wall sit, plank, glute bridge) completed for 4 sets with 1-2 minutes of rest between sets. Holds begin at 30 seconds and increase by 15 seconds per week to a maximum of 2 minutes. Intensity is 30% of maximum voluntary contraction for upper-body exercises and 95% of peak heart rate for lower-body exercises. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Arms: 1, 3, 5, 7 |
|
Experimentální: Core + AT + DRT
Participants receive the core intervention (Fitbit activity tracker and standard blood pressure health education) plus aerobic training (AT) and dynamic resistance training (DRT) for 6 months. AT: 4 sessions/week of moderate-to-vigorous endurance exercise, progressing from 40-59% to 60-89% heart rate reserve. DRT: 3 sessions/week of 6 exercises, 3 sets each, progressing from 50% to 70-80% of 1-repetition maximum. Each component includes 1 trainer-supervised videoconference session per week; remaining sessions are unsupervised and guided by manualized videos. |
All participants receive a wrist-worn Fitbit activity tracker (Charge 3 or similar) to wear daily during waking hours, synced to a secure coaching portal that study staff use to monitor wear adherence. Participants also receive standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) by email or mail twice per month for 6 months. Topics include hypertension and its health risks, BP self-monitoring, healthy eating, and active lifestyle strategies. Materials are non-interactive and standardized across all conditions. Arms: 1, 2, 3, 4, 5, 6, 7, 8 6-month remotely delivered endurance-based exercise program (e.g., walking, stair climbing) performed 4 sessions per week at moderate-to-vigorous intensity. Intensity begins at 40-59% heart rate reserve and progresses to 60-89% heart rate reserve, guided by 6-minute walk tests at baseline, 3 months, and 6 months. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Intensity is monitored by Fitbit heart rate and rating of perceived exertion. Arms: 1, 2, 3, 4 6-month remotely delivered resistance exercise program performed 3 sessions per week, consisting of 6 multi-joint, single-joint, and trunk exercises (e.g., squat, chest press, lunges, shoulder press), 3 sets each. Intensity begins at 50% of 1-repetition maximum and progresses to 70-80% of 1-repetition maximum by 6 months using overload principles, with 1-repetition maximum retested at 3 and 6 months. Participants receive an adjustable dumbbell set. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Sets, repetitions, and load are logged in the coaching portal. Arms: 1, 2, 5, 6 |
|
Experimentální: Core + AT + IRT
Participants receive the core intervention (Fitbit activity tracker and standard blood pressure health education) plus aerobic training (AT) and isometric resistance training (IRT) for 6 months. AT: 4 sessions/week of moderate-to-vigorous endurance exercise, progressing from 40-59% to 60-89% heart rate reserve. IRT: 3 sessions/week of a 3-exercise circuit, 4 sets of holds progressing to 2 minutes, at 30% maximum voluntary contraction (upper body) and 95% peak heart rate (lower body). Each component includes 1 trainer-supervised videoconference session per week; remaining sessions are unsupervised and guided by manualized videos. |
All participants receive a wrist-worn Fitbit activity tracker (Charge 3 or similar) to wear daily during waking hours, synced to a secure coaching portal that study staff use to monitor wear adherence. Participants also receive standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) by email or mail twice per month for 6 months. Topics include hypertension and its health risks, BP self-monitoring, healthy eating, and active lifestyle strategies. Materials are non-interactive and standardized across all conditions. Arms: 1, 2, 3, 4, 5, 6, 7, 8 6-month remotely delivered endurance-based exercise program (e.g., walking, stair climbing) performed 4 sessions per week at moderate-to-vigorous intensity. Intensity begins at 40-59% heart rate reserve and progresses to 60-89% heart rate reserve, guided by 6-minute walk tests at baseline, 3 months, and 6 months. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Intensity is monitored by Fitbit heart rate and rating of perceived exertion. Arms: 1, 2, 3, 4 6-month remotely delivered isometric exercise program performed 3 sessions per week, consisting of a 3-exercise circuit (e.g., wall sit, plank, glute bridge) completed for 4 sets with 1-2 minutes of rest between sets. Holds begin at 30 seconds and increase by 15 seconds per week to a maximum of 2 minutes. Intensity is 30% of maximum voluntary contraction for upper-body exercises and 95% of peak heart rate for lower-body exercises. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Arms: 1, 3, 5, 7 |
|
Experimentální: Core + AT
Participants receive the core intervention (Fitbit activity tracker and standard blood pressure health education) plus aerobic training (AT) for 6 months. AT: 4 sessions/week of moderate-to-vigorous endurance exercise (e.g., walking, stair climbing), progressing from 40-59% to 60-89% heart rate reserve. Includes 1 trainer-supervised videoconference session per week; remaining sessions are unsupervised and guided by manualized videos. |
All participants receive a wrist-worn Fitbit activity tracker (Charge 3 or similar) to wear daily during waking hours, synced to a secure coaching portal that study staff use to monitor wear adherence. Participants also receive standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) by email or mail twice per month for 6 months. Topics include hypertension and its health risks, BP self-monitoring, healthy eating, and active lifestyle strategies. Materials are non-interactive and standardized across all conditions. Arms: 1, 2, 3, 4, 5, 6, 7, 8 6-month remotely delivered endurance-based exercise program (e.g., walking, stair climbing) performed 4 sessions per week at moderate-to-vigorous intensity. Intensity begins at 40-59% heart rate reserve and progresses to 60-89% heart rate reserve, guided by 6-minute walk tests at baseline, 3 months, and 6 months. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Intensity is monitored by Fitbit heart rate and rating of perceived exertion. Arms: 1, 2, 3, 4 |
|
Experimentální: Core + DRT + IRT
Participants receive the core intervention (Fitbit activity tracker and standard blood pressure health education) plus dynamic resistance training (DRT) and isometric resistance training (IRT) for 6 months. DRT: 3 sessions/week of 6 exercises, 3 sets each, progressing from 50% to 70-80% of 1-repetition maximum. IRT: 3 sessions/week of a 3-exercise circuit, 4 sets of holds progressing to 2 minutes, at 30% maximum voluntary contraction (upper body) and 95% peak heart rate (lower body). Each component includes 1 trainer-supervised videoconference session per week; remaining sessions are unsupervised and guided by manualized videos. |
All participants receive a wrist-worn Fitbit activity tracker (Charge 3 or similar) to wear daily during waking hours, synced to a secure coaching portal that study staff use to monitor wear adherence. Participants also receive standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) by email or mail twice per month for 6 months. Topics include hypertension and its health risks, BP self-monitoring, healthy eating, and active lifestyle strategies. Materials are non-interactive and standardized across all conditions. Arms: 1, 2, 3, 4, 5, 6, 7, 8 6-month remotely delivered resistance exercise program performed 3 sessions per week, consisting of 6 multi-joint, single-joint, and trunk exercises (e.g., squat, chest press, lunges, shoulder press), 3 sets each. Intensity begins at 50% of 1-repetition maximum and progresses to 70-80% of 1-repetition maximum by 6 months using overload principles, with 1-repetition maximum retested at 3 and 6 months. Participants receive an adjustable dumbbell set. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Sets, repetitions, and load are logged in the coaching portal. Arms: 1, 2, 5, 6 6-month remotely delivered isometric exercise program performed 3 sessions per week, consisting of a 3-exercise circuit (e.g., wall sit, plank, glute bridge) completed for 4 sets with 1-2 minutes of rest between sets. Holds begin at 30 seconds and increase by 15 seconds per week to a maximum of 2 minutes. Intensity is 30% of maximum voluntary contraction for upper-body exercises and 95% of peak heart rate for lower-body exercises. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Arms: 1, 3, 5, 7 |
|
Experimentální: Core + DRT
Participants receive the core intervention (Fitbit activity tracker and standard blood pressure health education) plus dynamic resistance training (DRT) for 6 months. DRT: 3 sessions/week of 6 exercises (e.g., squat, chest press, lunges, shoulder press), 3 sets each, progressing from 50% to 70-80% of 1-repetition maximum. Includes 1 trainer-supervised videoconference session per week; remaining sessions are unsupervised and guided by manualized videos. |
All participants receive a wrist-worn Fitbit activity tracker (Charge 3 or similar) to wear daily during waking hours, synced to a secure coaching portal that study staff use to monitor wear adherence. Participants also receive standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) by email or mail twice per month for 6 months. Topics include hypertension and its health risks, BP self-monitoring, healthy eating, and active lifestyle strategies. Materials are non-interactive and standardized across all conditions. Arms: 1, 2, 3, 4, 5, 6, 7, 8 6-month remotely delivered resistance exercise program performed 3 sessions per week, consisting of 6 multi-joint, single-joint, and trunk exercises (e.g., squat, chest press, lunges, shoulder press), 3 sets each. Intensity begins at 50% of 1-repetition maximum and progresses to 70-80% of 1-repetition maximum by 6 months using overload principles, with 1-repetition maximum retested at 3 and 6 months. Participants receive an adjustable dumbbell set. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Sets, repetitions, and load are logged in the coaching portal. Arms: 1, 2, 5, 6 |
|
Experimentální: Core + IRT
Participants receive the core intervention (Fitbit activity tracker and standard blood pressure health education) plus isometric resistance training (IRT) for 6 months. IRT: 3 sessions/week of a 3-exercise circuit (e.g., wall sit, plank, glute bridge), 4 sets of holds progressing to 2 minutes, at 30% maximum voluntary contraction (upper body) and 95% peak heart rate (lower body). Includes 1 trainer-supervised videoconference session per week; remaining sessions are unsupervised and guided by manualized videos. |
All participants receive a wrist-worn Fitbit activity tracker (Charge 3 or similar) to wear daily during waking hours, synced to a secure coaching portal that study staff use to monitor wear adherence. Participants also receive standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) by email or mail twice per month for 6 months. Topics include hypertension and its health risks, BP self-monitoring, healthy eating, and active lifestyle strategies. Materials are non-interactive and standardized across all conditions. Arms: 1, 2, 3, 4, 5, 6, 7, 8 6-month remotely delivered isometric exercise program performed 3 sessions per week, consisting of a 3-exercise circuit (e.g., wall sit, plank, glute bridge) completed for 4 sets with 1-2 minutes of rest between sets. Holds begin at 30 seconds and increase by 15 seconds per week to a maximum of 2 minutes. Intensity is 30% of maximum voluntary contraction for upper-body exercises and 95% of peak heart rate for lower-body exercises. One session per week is supervised by a trainer via videoconference; the remaining sessions are completed independently using manualized videos. Arms: 1, 3, 5, 7 |
|
Experimentální: Core only
Participants receive the core intervention only for 6 months: a wrist-worn Fitbit activity tracker for daily wear and standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) delivered twice per month. No exercise components are prescribed. |
All participants receive a wrist-worn Fitbit activity tracker (Charge 3 or similar) to wear daily during waking hours, synced to a secure coaching portal that study staff use to monitor wear adherence. Participants also receive standard blood pressure health education materials (videos and flyers adapted from NHLBI and the American Heart Association) by email or mail twice per month for 6 months. Topics include hypertension and its health risks, BP self-monitoring, healthy eating, and active lifestyle strategies. Materials are non-interactive and standardized across all conditions. Arms: 1, 2, 3, 4, 5, 6, 7, 8 |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in resting systolic blood pressure
Časové okno: Baseline to 6 months
|
Resting brachial systolic blood pressure (mmHg) measured in person with a calibrated automated oscillometric device (SphygmoCor XCEL) after 10 minutes of rest. Three readings are taken 1 minute apart and averaged. Change from baseline will be compared between participants with each exercise component (AT, DRT, IRT) "on" versus "off." |
Baseline to 6 months
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in resting systolic blood pressure at 3 and 12 months
Časové okno: Baseline, 3 months, and 12 months
|
Resting brachial systolic blood pressure (mmHg), measured as for the primary outcome, to assess early response (3 months) and maintenance of effect after the intervention ends (12 months). Change from baseline will be compared between participants with each component "on" versus "off." |
Baseline, 3 months, and 12 months
|
|
Change in resting diastolic blood pressure
Časové okno: Baseline, 3 months, 6 months, and 12 months
|
Resting brachial diastolic blood pressure (mmHg) measured with a calibrated automated oscillometric device (SphygmoCor XCEL); average of three readings taken 1 minute apart. |
Baseline, 3 months, 6 months, and 12 months
|
|
Change in carotid-femoral pulse wave velocity
Časové okno: Baseline, 3 months, and 6 months
|
Central (aortic) arterial stiffness measured as carotid-femoral pulse wave velocity (m/s) by applanation tonometry (SphygmoCor). Only stable 10-second tracings with at least 80% of beats showing a detectable upstroke are included. |
Baseline, 3 months, and 6 months
|
|
Change in carotid-radial pulse wave velocity
Časové okno: Baseline, 3 months, and 6 months
|
Peripheral (muscular artery) stiffness measured as carotid-radial pulse wave velocity (m/s) by applanation tonometry (SphygmoCor). |
Baseline, 3 months, and 6 months
|
|
Change in total arterial stiffness
Časové okno: Baseline, 3 months, and 6 months
|
Total carotid pulse wave velocity (m/s) derived from carotid pressure and diameter measurements, used as the basis for separating structural and load-dependent stiffness. |
Baseline, 3 months, and 6 months
|
|
Change in structural arterial stiffness
Časové okno: Baseline, 3 months, and 6 months
|
Structural component of carotid pulse wave velocity (m/s), calculated with a participant-specific exponential model of arterial mechanics, with pressure and diameter adjusted to a standard reference pressure of 120/80 mmHg. |
Baseline, 3 months, and 6 months
|
|
Change in load-dependent arterial stiffness
Časové okno: Baseline, 3 months, and 6 months
|
Load-dependent component of carotid pulse wave velocity (m/s), calculated as total minus structural stiffness. Values are positive when blood pressure is above 120/80 mmHg and negative when below. |
Baseline, 3 months, and 6 months
|
|
Change in brachial artery flow-mediated dilation
Časové okno: Baseline, 3 months, and 6 months
|
Conduit artery endothelial function measured as percent flow-mediated dilation (%) by B-mode ultrasound after 5 minutes of lower-arm cuff occlusion at 250 mmHg, following a standardized brachial artery reactivity protocol. Peak diameter is recorded 60 and 90 seconds after cuff release. |
Baseline, 3 months, and 6 months
|
|
Change in common carotid artery distensibility
Časové okno: Baseline, 3 months, and 6 months
|
Change in common carotid artery diameter between systole and diastole (mm), measured in triplicate across 3 consecutive cardiac cycles by carotid ultrasound and read by a blinded central core lab. |
Baseline, 3 months, and 6 months
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in central blood pressure and aortic augmentation index
Časové okno: Baseline, 3 months, and 6 months
|
Central aortic systolic and diastolic blood pressure (mmHg) and aortic augmentation index normalized to a heart rate of 75 bpm (%), derived from radial artery waveforms using a validated generalized transfer function (SphygmoCor). |
Baseline, 3 months, and 6 months
|
|
Change in carotid artery wall echogenicity and texture
Časové okno: Baseline, 3 months, and 6 months
|
Grayscale median, entropy, gray-level difference statistics-contrast, and spatial gray level dependence matrices measured from carotid ultrasound images at end-diastole, reflecting early microstructural remodeling of the arterial wall. |
Baseline, 3 months, and 6 months
|
|
Change in moderate-to-vigorous physical activity
Časové okno: Baseline, 3 months, 6 months, and 12 months
|
Minutes per week of moderate-to-vigorous physical activity measured by hip-worn ActiGraph wGT3X-BT accelerometer over 7 days (valid wear: at least 10 waking hours per day on at least 5 days; at least 2,020 counts/min). |
Baseline, 3 months, 6 months, and 12 months
|
|
Change in 6-minute walk distance
Časové okno: Baseline, 3 months, 6 months, and 12 months
|
Submaximal aerobic capacity measured as distance walked (meters) in 6 minutes with standardized feedback. |
Baseline, 3 months, 6 months, and 12 months
|
|
Change in 1-repetition maximum strength
Časové okno: Baseline, 3 months, 6 months, and 12 months
|
Maximum weight (kg) a participant can lift once with proper form, used to assess muscle strength. |
Baseline, 3 months, 6 months, and 12 months
|
|
Muscle-strengthening exercise participation
Časové okno: Baseline, 3 months, 6 months, and 12 months
|
Self-reported muscle-strengthening activity over the past 7 days (type, frequency, duration, intensity, and muscle groups targeted) measured by the 9-item Muscle-Strengthening Exercise Questionnaire. |
Baseline, 3 months, 6 months, and 12 months
|
|
Change in body weight
Časové okno: Baseline, 3 months, 6 months, and 12 months
|
Body weight (kg) measured using standard protocols, explored as a mediator of blood pressure response. |
Baseline, 3 months, 6 months, and 12 months
|
|
Change in diet quality
Časové okno: Baseline, 3 months, 6 months, and 12 months
|
Healthy Eating Index score (0-100; higher scores indicate better diet quality) computed from three web-based Automated Self-Administered 24-Hour Recalls (two weekdays and one weekend day). |
Baseline, 3 months, 6 months, and 12 months
|
|
Exercise session adherence
Časové okno: Baseline to 6 months
|
Percentage of prescribed exercise sessions completed and percentage of total prescribed weekly dose time completed, tracked through Fitbit data and the coaching portal. |
Baseline to 6 months
|
|
Intervention acceptability
Časové okno: Monthly from month 1 to month 6
|
Acceptability of the assigned exercise program measured monthly by the Physical Activity Acceptance Questionnaire (6 administrations). |
Monthly from month 1 to month 6
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Deepika Laddu, PhD, Northwestern University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- STU00226723
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
De-identified individual participant data collected during the trial, including outcome, vascular, physical activity and covariate data, will be shared after study completion.
Časový rámec sdílení IPD
De-identified individual participant data and supporting information will be shared as soon as possible, and no later than the time of publication or the end of the award period, whichever comes first. Data will remain available in the repositories for a minimum of 5 years following the end of the grant period.
Kritéria přístupu pro sdílení IPD
De-identified participant-level clinical, laboratory, and processed vascular imaging data (with raw images excluded) will be deposited in the NHLBI Biological Specimen and Data Repository Information Coordinating Center (BioLINCC), along with the study protocol, data collection forms, sample informed consent, data dictionary, and a README file. Qualified researchers may request access through BioLINCC's standard application process; controlled-access data and biospecimens require a Research Materials Distribution Agreement (RMDA), valid for 3 years and renewable for an additional 3 years. Fully de-identified datasets will also be shared without access restrictions through Northwestern University's institutional repository (Arch) or Dryad, which will link to the BioLINCC record.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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