跳至主要内容
临床试验/NCT03200756
NCT03200756已完成不适用

The Effect of Cardiac Rehabilitation on Sedentary Behavior

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change in steps per day from before to after cardiac rehabilitation

研究概览

简要总结

This trial randomizes patients who plan to attend cardiac rehabilitation to either a behavioral intervention to specifically reduce sedentary behavior or to usual care which exclusively focuses on increasing exercise.

详细描述

Cardiac rehabilitation after a cardiac event or procedure is of key importance to physical and psychological recovery. Cardiac rehabilitation comprises a standardized stepwise approach to exercise in a supervised setting and is proven to reduce morbidity and mortality after a cardiac event. However, cardiac rehabilitation does not necessarily change behavior in the long-term and many do not attend cardiac rehabilitation due to lack of motivation, difficulty accessing programs, and cost. These individuals loose an important opportunity to improve their health, sense of well-being and outcomes. The investigators propose to test the effect of a patient-centered approach to reduce sedentary behavior for aging adults added to usual cardiac rehabilitation. In this study, the investigators will identify patients at their introductory visit to cardiac rehabilitation and randomize to either a program to decrease in-home sedentary behavior vs. a standard program to increase in-home exercise. Both groups will receive additional support and encouragement to attend cardiac rehabilitation. Using motivational interviewing techniques in both groups the investigators will assist the patients in recognizing their potential and goal-setting. Patients will be monitored using the ActivPAL monitor, a new technology that quantifies sedentary time and steps/day. Patients will be monitored four times as they proceed through cardiac rehabilitation for a total of 13 weeks and receive 3 educational and goal setting sessions. Those in the intervention group will have sedentary behavior change emphasized with feedback from the ActivPAL monitor. The control group will focus on standard exercise recommendations and feedback from his/her exercise diary. Outcomes include change in sedentary time and steps/day. Anticipated results include a significant change in the intervention group vs. the control: a decrease in in-home sedentary time, an increase in steps/day. The results of this study will provide the basis for designing a larger randomized controlled trial to investigate the effects of an intervention to reduce sedentary behavior as an adjunct to cardiac rehabilitation especially for older adults. Additional investigation will be warranted for those who do not attend cardiac rehabilitation but are able to follow a post-cardiac event program to reduce in-home sedentary behavior.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients enrolled in Cardiac Rehabilitation
  • •Age 50 years old or greater
  • •Short Physical Performance Battery (SPPB) score equal or less than 10

排除标准

  • •Orthopedic Disease that limits mobility
  • •Neurologic Disease that limits mobility
  • •Metastatic Cancer
  • •Life expectancy of <6 months
  • •Depression
  • •Montreal Cognitive Assessment less than 24
  • •Left Ventricular Assist Device (LVAD)
  • •Cardiac Transplant
  • •Patient Health Questionnaire-9 (PHQ-9) of 15 or greater

研究组 & 干预措施

Sedentary Group

Experimental

The experimental group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting.

干预措施: Sedentary Group (Behavioral)

Exercise Group

Active Comparator

The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting.

干预措施: Exercise Group (Behavioral)

结局指标

主要结局

Change in steps per day from before to after cardiac rehabilitation

时间窗: 1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study

The number of steps per day will be recorded using the Activpal monitor. Investigators will compare the number of steps per day prior to the subject beginning rehabiliation to the number of steps per day after cardiac rehabilitation is complete

Change in sedentary time from before to after cardiac rehabilitation

时间窗: 1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study

The number of sedentary hours per day will be recorded using the Activpal monitor.Investigators will compare the number of sedentary hours per day recorded prior to the subject beginning cardiac rehabilitation to the number of sedentary hours per day recorded after cardiac rehabilitation is complete

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验