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临床试验/NCT03311763
NCT03311763已完成不适用

A Multi-center Exercise Intervention for Persons Transitioning to Dialysis Using the "Exercise is Medicine" Framework

Stanford University4 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
4
主要终点
Differences in minutes of physical activity per week as measured by wearable device

研究概览

简要总结

The investigators plan to integrate and tailor the existing Exercise is Medicine framework, an evidence-based multi-level intervention program developed by the American Society of Sports Medicine, for the care of patients with advanced chronic kidney disease. In this pilot randomized control trial, investigators will compare the effects and feasibility of two intervention arms designed to start and maintain physical activity in this high-risk population (Group 1: physical activity assessment, brief counseling session + physical activity wearable versus Group 2: Group 1 intervention components + referral to a free, community-based, EIM practitioner led group exercise program).

详细描述

Persons on dialysis are physically inactive, with most reporting activity levels below the fifth percentile of healthy age-matched groups. Physical inactivity in turn increases the risk for functional decline and mortality in this vulnerable population. The investigators propose a pragmatic clinical trial for an exercise intervention among persons transitioning to dialysis. The investigators will use an existing framework - Exercise is Medicine (EIM) - developed by the American College of Sports Medicine. The investigators will randomize 98 persons from two regions-Atlanta and Bay Area-in two intervention arms with incremental levels of clinical-community integration: physical activity assessment during Nephrology clinical visit, brief counseling at pre-dialysis education and physical activity wearable (group 1) versus group 1 intervention components plus a referral to a free, EIM practitioner-led group exercise program over 16 weeks (group 2; 8 week core intervention; 8 week follow up). The investigators will assess efficacy by comparing between group differences in minutes/week of (measured) moderate intensity physical activity. To evaluate implementation, investigators will use questionnaires and exit interviews for assessing barriers to referral, participation and retention along the path of the intervention; investigators will use cost-utility analyses to assess scalability. Further the investigators will have a plan for dissemination of the intervention by partnering with insurance providers and both for-profit and non-profit dialysis organizations. The overall goal is to inform the development of a practical, cost-conscious intervention that addresses barriers to physical activity commonly faced by persons on dialysis, and can be delivered as a "package" to interested practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - eGFR < 30 ml/min/1.73m2
  • Age ≥30 and ≤80 years
  • Noncompliance with physical activity guidelines
  • Not in precontemplation stage
  • Non-wheelchair bound
  • Able to provide informed consent in English or Spanish
  • Anticipated to be living in the area over the next 36 weeks

排除标准

  • - Inability to provide consent in English
  • Diagnosed mental health disorder
  • Alcohol or drug abuse
  • No fixed address or contact details
  • Unstable angina or unstable arrhythmias
  • Lack of access to internet
  • Any concern not otherwise stated by patient's nephrologist

结局指标

主要结局

Differences in minutes of physical activity per week as measured by wearable device

时间窗: measured at baseline, 8 weeks and 16 weeks post start of intervention.

The Garmin wearable device will be used to track physical activity minutes during the week, with differences in total minutes per week in baseline versus 8 weeks (and 16 weeks) post intervention compared between exercise classes versus counseling alone groups

次要结局

  • Six minute walk test (6MWT)(measured at baseline, 8 weeks and 16 weeks post start of intervention.)
  • Handgrip(measured at baseline, 8 weeks and 16 weeks post start of intervention.)
  • Health-related Quality of life using Medical Outcomes Short form 12(measured at baseline, 8 weeks and 16 weeks post start of intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuchi Anand

Instructor in Medicine

Stanford University

研究点 (4)

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