Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Change in physical activity level from baseline to five to seven months
研究概览
简要总结
The purpose of this study was to compare the effect of an educational model, which included cardiac rehabilitation with emphasis on physical activity and telephone follow up, with the usual management of individuals undergoing to first percutaneous coronary intervention, in relation to physical activity five until seven months after discharge.
详细描述
Randomized controlled trial (RCT) at a public teaching hospital, which has specialized care for CAD in Ribeirão Preto, state of São Paulo, Brazil. The intervention group received usual care and an educational programme and the control group received only usual care.
A researcher (who didn't had contact with the patients) generated the random allocation in SPSS software, concealing it from the investigators in sequentially numbered, sealed and opaque envelopes.
Another researcher performed the individual interview with each participant (baseline) and aplied the instruments of socialdemographic data, physical activity, ansiety and depression, perceived health status and selfefficacy to practice of physical activity. At the end of the interviewThe same researcher opened the envelope to allocate the participants to either intervention or control group. The participants of intervention group remained with the researcher to receive the intervention.
The educational programme consisted of four booklets entitled 1. Percutaneous Transluminal Coronary Angioplasty, 2. Going home after your coronary angioplasty, 3. How to take care of your heart and your health, and 4. How to practice physical activities. The educational programme included the telephone follow-up that contained three calls to motivate the participants to change their lifestyle and clarify doubts. The contents of the booklets were explained step by step to the participants by the researcher who conducted the interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or more) of both genders
- •Patients undergoing the first percutaneous coronary intervention
- •Patients who had a properly functioning home phone line
排除标准
- •No cognitive conditions to participate (assessed by the ability to inform the name, current date, day of the week, place, age and place of birth confirmed by the participant's identification document)
- •Who did not have clinical or physical conditions to answer the questionnaires (individuals with dyspnea and / or mental confusion)
- •Who reported difficulties to speak on the phone (hearing loss)
- •Who had sequelae that could influence activities of daily living (limb amputation or paralysis)
- •Who had a contraindication to physical exercise, prescribed by the doctor, and who already participated in a supervised cardiac rehabilitation program
结局指标
主要结局
Change in physical activity level from baseline to five to seven months
时间窗: baseline and five to seven months
The "Baecke Questionnaire of Habitual Physical Activity" was developed by Baecke, Burema and Frijters (1982) and validated for the Brazilian population by Florindo et al. (2004, 2006). The instrument has three dimensions: occupational physical activity (eight questions), physical activity during leisure time (four questions) and leisure and locomotion activities (four questions), totaling 16 questions. Higher scores indicate a higher level of physical activity. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
次要结局
- Change in symptoms of anxiety and depression from baseline to five to seven months(baseline and five to seven months)
- Change in perceived health status from baseline to five to seven months(baseline and five to seven months)
- Change in self-efficacy for physical activity from baseline to five to seven months(baseline and five to seven months)
研究者
Natássia Condilo Pitta
PhD Student
University of Sao Paulo