NCT07238556Toboroz
A Novel Digital Tool Clinicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
Feasibility and Acceptability of a Novel Algorithm for Clinicians to Prescribe Personalized Exercise Prescriptions to Patients With Cardiovascular Disease Risk Factors: Study Protocol for an Exploratory Randomized Controlled Crossover Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 16.
Rövid összefoglaló (regiszter, angolul)
The investigators will conduct a feasibility and pilot efficacy randomized controlled trial to test the usability and user satisfaction of an evidence-based digital health tool the investigators developed for clinicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 clinicians, including physicians, physician assistants, or advanced practice registered nurses, from two local hospitals in CT, USA. Clinicians will recruit two patients each (N=48) having CVD risk factors. Clinicians will deliver a P3-EX exercise prescription (ExRx) to one of their patients (n=24) and the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) ExRx to the other (n=24) in a random sequence crossover design. Clinicians and patients will rate the feasibility and acceptability of each method using validated questionnaires. Patients will perform their prescribed ExRx for 12 weeks and complete a self-report exercise diary to monitor exercise adherence with virtual oversight from University of Connecticut (UConn) Graduate Research Assistants. Before and after the exercise intervention, the investigators will measure patient CVD risk factors and physical activity (PA) levels via accelerometry. The primary aim is to evaluate the feasibility and acceptability of P3-EX for clinicians to use to prescribe exercise to patients with CVD risk factors, and the secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence. The investigators hypothesize P3-EX will be feasible for clinicians to use to prescribe customized exercise routines for patients with CVD risk factors, and clinicians and patients will be satisfied with P3-EX.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 72 (tervezett)
- Első benyújtás
- 2025. nov. 7.
- Kezdés
- 2026. márc. 30.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- University of Connecticut
- Betegségek
- Magas vérnyomás, Elhízás
- NCT-szám
- NCT07238556
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 72
- 2026. márc. 30. és az elsődleges befejezés (2026. dec. 31.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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A regiszterben nem jelölt feltételek
- Clinician Inclusion Criteria
- Practicing physicians, physician assistants, or advanced practice registered nurses employed at the study recruitment sites
- Do not recommend written exercise programs or plans to all their patients, nor refer all their patients to exercise clinics or exercise professionals
- Are willing to recruit two of their patients to deliver Prioritize Personalize Prescribe EXercise (P3-EX) and American College of Sports Medicine Physical Activity Vital Sign (ACSM PAVS)
- Patient Inclusion Criteria
- Sedentary: have not performed planned, structured physical activity at moderate intensity for ≥30 minutes on ≥3 days per week in the last 3 months
- Adults: ≥18 and ≤64 yrs
- ≥1 cardiovascular disease risk factors: Having obesity, hypertension, dyslipidemia, and/or diabetes (or prediabetes)
- Obesity: BMI ≥30 kg/m2 or WC >102 cm (40 in) for men and >88 cm (35 in) for women
- Hypertension: Systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg, or on antihypertensive medication
- Dyslipidemia: LDL-C ≥130 mg/dL (3.37 mmol/L), or HDL-C <40 mg/dL (1.04 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women, or non-HDL-C ≥160 mg/dL (4.14 mmol/L), or on lipid-lowering medication, or TC ≥200 mg/dL (5.18 mmol/L)
- Diabetes (or prediabetes): FBG ≥100 mg/dL or HbA1c ≥5.7%, or on medication for diabetes
- Healthy: Having no signs or symptoms of or have cardiovascular or renal disease, or other diseases or health conditions that significantly limit physical activity engagement
- Not pregnant or lactating
- Not a cigarette smoker or quit smoking ≥6 months ago
- Consume <2 alcoholic drinks daily
- Able to use a computer or phone with internet access
- Fluent in English
- Willing to maintain their medication routine and habitual diet and not follow other exercise or nutrition programs.
- Patient Exclusion Criteria 4a. Have pain or discomfort in the chest, neck, jaw, or arms; dizziness or syncope; shortness of breath at rest or with mild exertion; unusual fatigue or shortness of breath with usual activities; orthopnea; ankle edema; intermittent claudication; palpitations; or known heart murmur 4b. Stroke or cancer survivors or currently have cancer, chronic obstructive pulmonary disease, musculoskeletal injury, chronic back pain, depression, dementia, or other diseases or health conditions that are deemed to significantly limit physical activity engagement.
Életkor a regiszterben: 18 év – 64 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| UConn Health | Farmington | Egyesült Államok | Toborzás még nem indult |
| Hartford Healthcare | Hartford | Egyesült Államok | Toboroz |
| University of Connecticut | Storrs | Egyesült Államok | Toboroz |
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