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临床试验/NCT03909919
NCT03909919
已完成
不适用

Functional Parameters Indicative of Heart Failure.

University of Malaga1 个研究点 分布在 1 个国家目标入组 34 人2020年1月18日
适应症Heart Failure

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Heart Failure
发起方
University of Malaga
入组人数
34
试验地点
1
主要终点
Responsiveness
状态
已完成
最后更新
7个月前

概览

简要总结

The present study aims to validate the kinematic analysis obtained by two motion capture instruments for the functional objective assessment of elderly patients with Heart Failire (HF) and to develop a new functional index formed by kinematic parameters and other functional objective parameters and scales which may be impaired in patients with HF and they could allow the stratification of these patients based on different levels of functional impairment.

详细描述

Cardiovascular diseases carried on being the leading cause of disability due to noncommunicable diseases from 1990 to 2016. Within cardiovascular diseases, it has been estimated that heart failure (HF) has a prevalence in the population of approximately 2% to 3%. However, it is the only cardiovascular disease that is increasing in incidence and prevalence due to the aging of the world population, since the prevalence of this disease increases with age. Furthermore, heart failure represents the most important hospital diagnosis in older adults, being the main cause of hospital admissions for people older than 65 years and contributing to the increase of medical care costs. Subjects with HF use to show a reduced aerobic capacity, a decreased muscle strength in the lower limbs, low weekly physical activity, intolerance to exercise and a lower walking speed than healthy subjects of the same age. In general, patients with heart failure have altered functional capacities and experience a decline in the ability to carry out activities of daily living and suffer a reduced quality of life. When it is assessed functional parameters in patients with heart failure, the maximum oxygen consumption (V0₂ max) obtained from a cardiopulmonary exercise test is considered the gold standard measure of cardiovascular functional capacity. Moreover, some functional tests have been used, such as the 6-Minute Walking Test, which provides an indirect measure of cardiovascular functional capacity, and the Short Physical Performance Battery (SPPB), which also provides a useful and indirect indication of muscle functional capacity. However, at the time of diagnosing or classifying patients with heart failure, the functional assessment does not use to be considered. The implementation of diagnostic guidelines or a functional assessment based on evidence can be important to improve prognosis and quality of life in patients with HF. Therefore, there is a need to identify functional markers related to functionality that are indicative of heart failure. For this, it is necessary to use instruments to measure functional variables that must be valid and reliable, as established by the COSMIN taxonomy. Kinematic measurements allow quantifying normal and pathological movements, quantifying the degree of deterioration, planning rehabilitation strategies and evaluating the effect of various interventions. Inertial sensors and depth cameras are accurate and reliable methods for the kinematic analysis of human movement, in addition to presenting a good correlation of kinematic data between them. Currently, it can be used the Simmer3 Inertial Sensor and 3D motion capture systems with a camera to analyse kinematics and these instruments are being integrated as a rehabilitation tool in patients. The use of Shimmer3 Inertial Sensor and 3D motion capture cameras would help to find fast and cheap assessment methods for professionals.

注册库
clinicaltrials.gov
开始日期
2020年1月18日
结束日期
2024年5月18日
最后更新
7个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Dr. Antonio I Cuesta-Vargas

PhD. Titular Doctor Physiotherapy Department, University of Malaga. Principal investigator.

University of Malaga

入排标准

入选标准

  • Subjects older than 70 years.
  • Healthy subjects and subjects diagnosed with Heart failure.
  • Subjects able of filling out questionnaires and performing functional tests.
  • subjects who are in a clinical stability and optimal treatment phase.

排除标准

  • Participants with cardiac pathologies other than heart failure.
  • Score in the NYHA scale equal to
  • Hospitalization in a period of time equal to or less than 3 months.
  • Score on the Mini-Mental scale below
  • Inability to get up from the chair at least 5 times or 30 seconds.
  • Inability to walk for 6 minutes.
  • Inability to walk independently without a walking assistance device (cane, crutch or walker).
  • Subjects participating in an experimental study where they receive a treatment.
  • Inability to provide informed consent.

结局指标

主要结局

Responsiveness

时间窗: 1 hour

The Responsiveness Box of COSMIN checklist will be used to determinate the response to change of the Shimmer 3 Inertial Sensor and the 3D cameras. All possible items will be followed.

Motion parameters

时间窗: 1 hour

Kinematic parameters will be analysed using an inertial sensor included in the Shimmer3 instrument during the performance of different functional task.

Kinematic analysis by 3D motion capture

时间窗: 1 hour

A camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.

Reliability

时间窗: 1 hour

The Reliability Box of COSMIN checklist will be used to determinate the Test-Retest reliability of the Shimmer3 Inertial Sensor and the 3D cameras. All possible items will be followed.

次要结局

  • abbreviated comprehensive geriatric assessment (aCGA): a questionnaire formed by items originating from four different scales.(15 minutes)
  • SARC-F(10 minutes)
  • Cardiopulmonary function(1 hour)
  • Quadriceps thickness(15 minutes)
  • Quadriceps muscle echo-intensity(15 minutes)
  • Mortality(until the end of the study)

研究点 (1)

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