Feasibility and Acceptability of a Novel Algorithm for Physicians to Prescribe Personalized Exercise Prescriptions to Patients With Cardiovascular Disease Risk Factors: Study Protocol for an Exploratory Randomized Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
研究概览
简要总结
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 physicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 physicians from two local hospitals in CT, USA. Physicians will recruit two patients each (N=48) having CVD risk factors. Physicians 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. Physicians 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 physicians 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 physicians to use to prescribe customized exercise routines for patients with CVD risk factors, and physicians and patients will be satisfied with P3-EX.
详细描述
Background
Approximately half of U.S. adults have 1 or more of the major CVD risk factors of obesity, hypertension, dyslipidemia, and diabetes, and 1 in 4 have 3 or more. Professional organizations such as the American College of Sports Medicine (ACSM) and the American Heart Association (AHA) recommend exercise as a first-line lifestyle therapy to prevent and treat CVD and its risk factors. The ACSM advocates clinicians to assess PA as a vital sign and prescribe exercise for every patient. However, only about 20% of U.S. adults and 44-56% of patients with CVD risk factors report being advised by their health care providers to exercise. Although physicians are receptive to prescribing exercise to their patients, they encounter barriers to doing so such as a lack of time, training, and the tools. Digital health tools show promise as clinical decision support systems to guide physicians in prescribing exercise to their patients. The investigators developed a clinical decision support tool named P3-EX. P3-EX includes: 1) the ACSM exercise preparticipation health screening recommendations to determine if there is a need for medical clearance; 2) an adapted AHA Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk; 3) the ACSM strategies for designing an ExRx for adults with multiple CVD risk factors; and 4) the ACSM Frequency, Intensity, Time, Type (FITT) ExRx for the prioritized CVD risk factor posing the greatest risk.
Objectives
The primary aim of this trial is to evaluate the feasibility and acceptability of P3-EX for physicians to use to prescribe exercise to patients with CVD risk factors.
The secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Outcome assessors (Graduate Research Assistants) of vitals, body composition, and physical activity levels will be blinded to intervention assignments at baseline. Outcome assessors (laboratory technicians) of blood lipid-lipoprotein and blood glucose profiles will be blinded to intervention assignments. The healthcare providers (physicians) who will deliver the intervention, the participants (patients) who receive the intervention; and the investigators (Graduate Research Assistants) who will provide exercise intervention oversight will have knowledge of will intervention assignment due to feasibility and the behavioral nature of the trial.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician Inclusion Criteria
- •Practicing medical doctors employed at the study recruitment sites
- •Do not recommend written exercise programs or plans to their patients, nor refer them 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.
排除标准
- •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.
研究组 & 干预措施
Prioritizes Personalizes Prescribes EXercise (P3-EX)
Physicians will use Prioritizes Personalizes Prescribes Exercise (P3-EX), hosted by a web-based platform, to deliver P3-EX, an evidence-based personalized exercise prescription to improve cardiovascular disease (CVD) risk factors.
P3-EX will determine whether the patient needs medical clearance. P3-EX will score the patient's CVD risk factors using an adapted American Heart Association Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk. If ≥2 CVD risk factors are tied for the greatest risk, P3-EX will prompt the physician to choose an American College of Sports Medicine strategy to prioritize one CVD risk factor to personalize the Frequency, Intensity, Time, and Type (FITT) exercise prescription. P3-EX will also produce special exercise considerations for the prioritized CVD risk factor. The physician will print the exercise prescription and give it to the patient to perform for 12 weeks.
干预措施: Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants (Behavioral)
American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS)
Physicians will use a hard copy instruction manual adapted from the Exercise is Medicine HealthCare Providers' Action Guide to deliver the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), a generic exercise program to improve general health.
The physician will ask the patient exercise preparticipation health screening questions to determine whether medical clearance is needed. The physician will assess their patient's physical activity levels as a vital sign (i.e., minutes per week of moderate to vigorous intensity exercise and days per week of resistance exercise). The physician will give the patient the ACSM-PAVS exercise program as a handout, which recommends the Physical Activity Guidelines for Americans of 150 minutes per week of moderate and/or 75 minutes per week of vigorous intensity aerobic exercise (or a combination) and 2 days per week of muscular strengthening exercise.
干预措施: Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants (Behavioral)
结局指标
主要结局
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
时间窗: Within 48 hours following the delivery of P3-EX and ACSM-PAVS
The mHealth Application Usability Questionnaire is validated to measure the usability of mobile health apps for healthcare providers and/or patients through 21 items spilt into three subscales; Ease of Use and Satisfaction, System Information Arrangement, and Usefulness. The rating of each item is scaled from 1 to 7, and responses are averaged to provide a single score. Physicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be compared to the middle score of 4.0.
次要结局
- Blood Glucose Profile Changes(12 weeks)
- Resting Blood Pressure Changes(12 weeks)
- Physician Barriers to and Confidence with Exercise Prescription (ExRx)(Before completing brief ExRx training and within 48 hours following the delivery of either P3-EX or ACSM-PAVS)
- American Heart Association Life's Essential 8 Score Change from Baseline(12 weeks)
- Resting Heart Rate Changes(12 weeks)
- Body Mass Index Changes(12 weeks)
- Waist Circumference Changes(12 weeks)
- Blood Lipid-Lipoproteins Profile Changes(12 weeks)
- Subjective Physical Activity Levels Changes(Weekly for 12 weeks)
- Objective Physical Activity Level Changes(12 weeks)
- Sedentary Behavior Changes(12 weeks)
- Exercise Adherence(Weekly for 12 weeks)
- Energy Expenditure Changes(12 weeks)
- Step Count Changes(12 weeks)
研究者
Linda Pescatello
Board of Trustees Distinguished Professor
University of Connecticut