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临床试验/NCT04647851
NCT04647851已完成不适用

Effects of a Remote Exercise Intervention on Aerobic Endurance, Strength, Gait and Balance in Individuals With Down Syndrome - Pilot Study

University of Nevada, Las Vegas1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年11月18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
Aerobic endurance

研究概览

简要总结

This pilot study aims to test whether remote delivery of the exercise intervention provides a sufficient training stimulus. This pilot study will be remote and online-only, and will have no in-person interaction, data collection or intervention. 20 Participants will participate in a 12-wk, 3hrs/wk remote exercise intervention and in a pre- and a posttest remote testing session. We will use Zoom for all testing and exercise sessions.

详细描述

Design: Repeated measures design: 20 participants will participate in the remote exercise intervention study with a pre-test and a post-test to investigate training effects on aerobic endurance, strength, balance and gait.

Intervention: The program we will be using is specifically developed for individuals with Down syndrome based on the Mann Method PT Principles. The MMPT Principles TM focus on a progressive program of therapeutic activity (cardiovascular activity), therapeutic exercise (foundational strengthening and hip strengthening activities), and neuromuscular rehabilitation (visual/vestibular and balance activities) to address the unique needs of individuals with Down syndrome. This program has been developed and successfully implemented in Down syndrome activity centers across the country. This program will be offered through Zoom. Intensity will be submaximal for both data collection and during the exercise sessions, and recorded with Polar heart rate monitors.

Measurements: We will use only field tests instead of the original lab-based testing for aerobic endurance, strength, balance and gait, and all tests will be conducted remotely.

Baseline measurements: height, weight, circumferences Aerobic endurance: 2 Minute Step Test: participant marches in place as fast as possible with a set height for how high to lift the knees, for two minutes. Outcome is heart rate and number of steps in two minutes.

Strength: 30 Second Chair Stand and 5 Times Chair Stand: participants starts seated, then stands up and sits down as fast as possible, first counting the number of times within 30 seconds, then timing the number of seconds for 5 times.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Between 18 and 35 years old
  • •generally healthy
  • •sedentary (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)
  • •additionally for the participants with Down syndrome:
  • •diagnosis of Down syndrome trisomy 21 and
  • •normal thyroid function or stable thyroid function (and medications) for at least 6 mo.

排除标准

  • •congenital heart disease;
  • •atherosclerotic or other vascular disease;
  • •asthma or other pulmonary disease;
  • •hypertension (defined BP >140/90 mmHg);
  • •blood pressure below 90/60 mmHg;
  • •history of pre-syncope or syncope;
  • •diabetes (defined as Hba1c of >7.5% or use of glucose lowering medication);
  • •severe obesity (defined as BMI >40);
  • •medications affecting heart rate, blood pressure or arterial function;
  • •anti-inflammatory medication including NSAIDS;
  • •current smoking and
  • •pregnancy.

研究组 & 干预措施

Remote exercise intervention Down syndrome

Experimental

Intervention: The program we will be using is specifically developed for individuals with Down syndrome based on the Mann Method PT Principles. The MMPT Principles TM focus on a progressive program of therapeutic activity (cardiovascular activity), therapeutic exercise (foundational strengthening and hip strengthening activities), and neuromuscular rehabilitation (visual/vestibular and balance activities) to address the unique needs of individuals with Down syndrome. This program has been developed and successfully implemented in Down syndrome activity centers across the country. This program will be offered through Zoom. Intensity will be submaximal for both data collection and during the exercise sessions, and recorded with Polar heart rate monitors.

干预措施: Remote exercise intervention Down syndrome (Other)

结局指标

主要结局

Aerobic endurance

时间窗: 13 weeks

We measure aerobic endurance with the 2-min Step Test, outcome measure is number of times the right leg is lifted.

次要结局

  • Balance(13 weeks)
  • Gait(13 weeks)
  • Leg strength(13 weeks)

研究者

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

Thessa Hilgenkamp

Assistant Professor

University of Nevada, Las Vegas

研究点 (1)

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