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临床试验/NCT02753829
NCT02753829已完成不适用

Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease

Ágata Sofia da Silva Vieira0 个研究点目标入组 33 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
主要终点
Quality of life using EADS-21 (depression, anxiety and stress scale)

研究概览

简要总结

The sample of this randomized controlled trial was obtained in the Cardiovascular Prevention and Rehabilitation Unit, of the Hospital Centre of Porto, Santo Antonio General Hospital. The target population was individuals who have completed the training phase of cardiovascular rehabilitation program, volunteers and referenced by the responsible for the service.

This study has as main objective to analyze the influence of a specific exercise program, maintenance phase of cardiovascular rehabilitation , in home care context, for a period of 6 months, using a virtual format (computer and Kinect) or a conventional format (paper manual) in subjects with coronary artery disease. It was intended to analyze the immediate effect of exercise program on body composition and food consumption patterns, functional muscle strength of lower limb, level of physical activity: total volume of activity as well as the profile of this intensity, kyphotic index, balance, cognitive and executive function, as well as in the quality of life.

The aim is also to examine the effects, approximately 3 months after the end of the exercise program, in the lipid profile, the level of physical activity: total volume of activity as well as the profile of this intensity and cardiovascular fitness: maximum double product ; metabolic equivalents; and proof and recovery time.

The individuals were distributed at random, every 3 individuals, using the capabilities of Microsoft Excel 2010 RANDBETWEEN command, by three groups: the experimental group 1- a cardiovascular rehabilitation program, in home care context, using a computer and Kinect, virtual format, the experimental group 2- in cardiovascular rehabilitation program, in home care context, using a paper-based manual, conventional format, and control group-only subject to education for cardiovascular risk factors.

The program defined 3 training sessions per week. The rehabilitation program was oriented by the guidelines for exercise prescription.

Participants perform the a program of specific exercises independently and individually, with remote supervision, using communication (phone, email, etc.) and a routine scheduled individual meetings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • coronary artery disease diagnosed and stabilized
  • both sexes
  • aged between 40 and 75 years
  • individuals were to have performed and completed the training phase of cardiovascular rehabilitation
  • individuals should have a computer with at least Microsoft Windows 7

排除标准

  • heart surgery
  • individuals whose stress test did not end for maximum fatigue
  • individuals in gestation period or wishing to become pregnant
  • individuals classified as cardiovascular high-risk
  • individuals with pacemakers or with severe neurological, musculoskeletal or respiratory diseases and metabolic unbalanced disease or reported dementia, cardiomyopathies, history of cardio respiratory arrest don't associated with acute myocardial infarction or cardiac procedures
  • individuals with significant visual and auditory deficits not compensated
  • individuals illiterate and / or without knowledge of Portuguese language
  • Individuals who were in, or wanted to do gyms or other regular exercise programs during the study

结局指标

主要结局

Quality of life using EADS-21 (depression, anxiety and stress scale)

时间窗: 6 months

Lipid Profile using laboratory tests

时间窗: 9 months

Cardiovascular fitness using the stress test

时间窗: 9 months

Physical activity using the accelerometer

时间窗: 9 months

Quality of life using Macnew (heart disease health-related quality of life questionnaire)

时间窗: 6 months

次要结局

  • Food consumption patterns using the food frequency questionnaire(6 months)
  • Fat mass of the trunk using the balance of bioimpedance(6 months)
  • Lean body mass using the balance of bioimpedance(6 months)
  • Balance using Star Excursion Balance Test(6 months)
  • Total fat mass using the balance of bioimpedance(6 months)
  • Balance using the One leg standing test(6 months)
  • Kyphotic index using the flexicurve(6 months)
  • Weight using the balance of bioimpedance(6 months)
  • Waist hip ratio using the tape measure(6 months)
  • Waist height ratio using the tape measure(6 months)
  • Cognitive function using the Trail Making Test(6 months)
  • Cognitive function using the Verbal Digit Span Test(6 months)
  • Cognitive function using the Stroop Test(6 months)
  • Functional muscle strength of lower limb using the Sit-to-stand test(6 months)

研究者

发起方
Ágata Sofia da Silva Vieira
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ágata Sofia da Silva Vieira

PHD Student

Universidade do Porto

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