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临床试验/NCT04043546
NCT04043546已完成不适用

Observational Feasability Study of Home-based Training With Therabands in PAD-patients - Addressing the Uncertainty of Acceptance, Satisfaction and Usability of a Home-based, Tele-monitored Program Combining Aerobic and Resistance Components in PAD-patients.

KU Leuven1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年10月1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
发起方
KU Leuven
入组人数
20
试验地点
1
主要终点
user satisfaction

研究概览

简要总结

The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.

研究设计

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

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 50 yrs;
  • ankle-brachial index (ABI) ≤ 0.9 in one or two legs;
  • Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated);
  • body mass index <35 kg/m 2 ;
  • resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg;
  • ability to walk at least 2 min at 2.0 mph;
  • ability to undertake an incremental treadmill test;
  • decrease of at least 15% in ABI after a maximal treadmill test;
  • not currently engaging in any regular exercise program.

排除标准

  • exercise induced signs of myocardial ischemia or complex ventricular arrhythmias;
  • no access to laptop or internet;
  • no medical clearance for exercise

研究组 & 干预措施

Exercise intervention

Experimental

干预措施: aerobic+resistance exercise training program (Behavioral)

结局指标

主要结局

user satisfaction

时间窗: 4 weeks

self-developed questionnaire based evaluation of user satisfaction

walking distance

时间窗: 4 weeks

pain free and maximal walking distance are recorded using the Gardner treadmill protocol.

次要结局

  • Physical activity(2 months)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roselien Buys

Principal Investigator

KU Leuven

研究点 (1)

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