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临床试验/NCT02911493
NCT02911493已完成不适用

Reducing Sedentary Time in Patients With Heart Failure

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年9月最近更新:
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
50
试验地点
2
主要终点
Number of Subjects that are more active than Control.

研究概览

简要总结

To determine the change in sedentary time and number of steps/day for older patients with heart failure at risk for mobility disability who receive a program to decrease sedentary behavior versus a standard program to increase exercise.

研究设计

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

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • NYHA II-IV,
  • Age ≥ 65,
  • SPPB score of > 4 and ≤ 10 of 12,
  • and deemed (by 1° cardiologist) to be at maximal tolerated dose of heart failure medication (ACE-inhibitor (ACE-I)/angiotensin receptor blocker and beta blocker (BB) for patients with HF with reduced ejection fraction (HFrEF), and
  • blood pressure controlled for HF with preserved ejection fraction (HFpEF) according to the American Heart Failure Association HF guidelines.

排除标准

  • Patients requiring medication titration such as ACE-I or BB, (will return to their cardiologist and be eligible after 3 months of stable medication.)
  • Oxygen dependent lung disease,
  • Orthopedic or neurologic disease that severely limits mobility,
  • Active cancer diagnosis except non-melanoma skin cancer,
  • Geriatric Depression Scale (GDS) score of ≥ 9 ,
  • Limited life-expectancy of <6 months,
  • Known dementia or disease that effects ability to learn/follow directions, or
  • Failed MiniCog test.

研究组 & 干预措施

Sedentary Group-Experimental

Experimental

The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.

干预措施: Reducing Sedentary Behavior (Behavioral)

Physical Activity Group

Active Comparator

The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.

干预措施: Physical Activity Group (Behavioral)

结局指标

主要结局

Number of Subjects that are more active than Control.

时间窗: Monthly for 3 months

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 (2)

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