Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 4
- 主要终点
- Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via:
研究概览
简要总结
A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit) against usual care in increasing physical activity levels in patients with Coronary Artery Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.
详细描述
Most existing cardiac rehabilitation programs have little ability to expand participation using traditional delivery models that emphasize supervised, facility-based programs. Futhermore, facility based programs to promote physical activity behavior in patients with coronary artery disease (CAD) are limited in their impact because most patients are unwilling to travel more than 30-40 minutes to participate in a program. CardioFit is an off-site, 26 week web-based physical activity coaching service for people with heart disease. Within the CardioFit program, patients will be assigned to an on-line "coach" and receive customized exercise programs based on their medical history, personal goals and preferences. A randomized control trial (RCT) is planned to evaluate the effectiveness of the web-based intervention at increasing physical activity levels against usual care in patients with CAD.
This study is in the third phase of a three-phase research program to examine interventions to promote physical activity for the secondary prevention of Cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
盲法说明
The Research Assistants conducting the follow-up assessments were blinded to the participant's treatment allocation.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 80 years
- •English Proficiency
- •Internet Access (home or work)
- •Documented CAD (most recent cardiac diagnosis); documented Myocardial Infarction (MI), successful PCI procedure
排除标准
- •Patient intends to enroll in structured cardiac rehabilitation
- •Hospitalization for Coronary Artery Bypass (CABG)
- •Hospitalization for diagnostic procedure not associated with previously documented MI
- •Patient coming back to hospital for planned staged PCI within 6 months
- •Cardiac transplantation
- •Presence of, or hospitalization for defibrillator implant
- •Hospitalization for pacemaker implantation
- •Unresolved unstable angina &/or hospitalization for angina (without MI or PCI)
- •Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- •Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise
- •Other uncontrolled metabolic conditions (e.g. diabetes)
- •Chronic infectious diseases such as mononucleosis, hepatitis, AIDS
- •Acute systematic illness or fever
- •Uncontrolled tachycardia (<120 bpm)
- •Uncompensated congestive heart failure (&/or NYHA Class III, or IV)
- •3rd degree AV block without pacemaker
- •Active pericarditis or myocarditis
- •Recent embolism
- •Suspected or known AAA aneurysm > 4cm
- •Uncontrolled hypertension (SBP > 200; DBP > 110)
- •Pregnancy
研究组 & 干预措施
Cardio fit
干预措施: CardioFit (Behavioral)
Usual Care
结局指标
主要结局
Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via:
时间窗: Baseline, 6 and 12 months
Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer
时间窗: Baseline, 6 and 12 months
次要结局
- Barriers(Baseline, 6 and 12 months)
- Task Self-efficacy(Baseline, 6 and 12 months)
- Use of secondary prevention medications(6 and 12 months)
- Social Support(Baseline, 6 and 12 months)
- Pedometer (9days)(6 and 12 months)
- Recurrent cardiac events(Baseline, 6 and 12 months)
- Perceived environment(Baseline, 6 and 12 months)
- Measured at baseline, 6 months, and 12 months via follow-up questionnaire:(Baseline, 6 and 12 months)
- Outcome expectations(Baseline, 6 and 12 months)
- Heart disease specific quality of life(Baseline, 6 and 12 months)
- Moderate or Vigorous Physical Activity(baseline to 12 months)
- Heart Disease Health-related Quality of Life(6 months and 12 months)