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Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study (IMPACT)

2021年3月15日 更新者：Latha Palaniappan, MD, MS、Stanford University
The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the optimal and feasible level of frequency of structured contact needed in a clinical setting for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity recommendations long-term.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The IMPACT Study will compare the health outcomes and lifestyle habits amongst the three groups of study participants. Study participants will be randomized into three exercise group. Group 1 will participate in instructor-led exercise training sessions 1 time per week, for 24 weeks (approximately 6 months). Group 2 will participate in instructor-led exercise training sessions 3 times per week, for 24 weeks (approximately 6 months). Group 3 will not attend any instructor-led exercise training sessions. All groups will be encouraged to see their usual providers for routine healthcare, and continue their usual medication regimen.

研究类型

介入性

注册 (实际的)

354

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Palo Alto、California、美国、94304
        • Stanford University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Recent hemoglobin A1c result between 6.5 and 13.0%
  • Diagnosed with Type 2 Diabetes Mellitus
  • Able and willing to enroll and meet the requirements of the study

Exclusion Criteria:

  • Inability to speak, read or understand English
  • Long-term current use or dependency on insulin
  • Systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg
  • Resting heart rate > 120 bpm
  • History of or present heart or cardiovascular conditions
  • History of or present respiratory disease
  • History of or present spinal cord injury
  • History of stroke or Transient Ischemic Attack (TIA)
  • History of cancer diagnosis in the past 5 years or present cancer diagnosis
  • Medical, psychiatric, behavioral limitations that may interfere with study participation
  • Participating in other clinical trials that may interfere with study procedures and outcomes
  • Currently pregnant or plans to become pregnant within three years

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Once-Weekly Structured Contact
Participants in the Once Weekly Structured Contact group will take part in an 6-month exercise intervention and attend one structured group exercise session per week. They will engage in aerobic and resistance training for approximately 80 minutes per exercise session. Additionally, they will attend three exercise evaluations and six study visits.
行为的：Structured Group Exercise
The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
实验性的：Thrice-Weekly Structured Contact
Participants in the Thrice-Weekly Structured Contact group will take part in an 6-month exercise intervention and attend three structured group exercise sessions per week. In total, they will engage in aerobic and resistance training sessions for approximately 200 minutes per week. Additionally, they will attend three exercise evaluations and six study visits.
行为的：Structured Group Exercise
The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
无干预：Usual Care
Participants in the Usual Care group will not take part in an 6-month exercise intervention. They will continue to seek regular care from their primary care providers and attend six study visits.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Changes in Hemoglobin A1c Level Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Maximal Oxygen Consumption Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Physical Activity Level Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

次要结果测量

结果测量
大体时间
Changes in Body Weight Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Body Mass Index Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Waist Circumference Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Blood Pressure Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Heart Rate Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Dietary Intake Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Quality of Life Across Study Visits
大体时间：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Exercise Perception Across Study Visits
大体时间：Baseline, 6-, 30-month follow-up
Baseline, 6-, 30-month follow-up
Changes in Patient Satisfaction During Intervention Period
大体时间：3-, 6-month follow-up
3-, 6-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stanford University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年10月1日

初级完成 (实际的)

2020年1月1日

研究完成 (实际的)

2020年1月1日

研究注册日期

首次提交

2014年2月11日

首先提交符合 QC 标准的

2014年2月11日

首次发布 (估计)

2014年2月13日

研究记录更新

最后更新发布 (实际的)

2021年3月17日

上次提交的符合 QC 标准的更新

2021年3月15日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 31635
  • U.S. NIH Grant 5R18DK096394 (其他赠款/资助编号：U.S. NIH Grant/Contract Award Number)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

糖尿病的临床试验

Structured Group Exercise的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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