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临床试验/CTRI/2020/04/024722
CTRI/2020/04/024722尚未招募不适用

Prevalence of sarcopenia and its association with function and mobilityin acute decompensated heart failure

Lakshman Iyer1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
4. Bioelectrical Impedance Analysis

研究概览

简要总结

This a cross sectional study to investigate the prevalence of Sarcopenia and it’s association with function and mobility in Acute Decompensated Heart Failure.

AIM:

To determine prevalence of sarcopenia and impact of acute decompensated heart failure on function and mobility

 OBJECTIVES:

  1. Assess the prevalence of sarcopenia in individuals with acute decompensated heart failure

  2. Assess the association of sarcopenia with function and mobility in individuals with acute decompensated heart failure

  3. To determine outcomes (MACE & Mobility disability) at 1, 3 and 6 months post discharge

PROCEDURE:

110 participants with ADHF will be included in the study based on screening done for inclusion and exclusion criteria. Informed consent will be taken from every participant prior to collection of data. Outcome measures will be assessed once patient is stable. Participants will be explained the procedure prior to performance, and standard guidelines will be followed at all times.

The European Working Group on Sarcopenia in Older People 2 (EWGSOP2) algorithm will be administered as follows:

·         Starting with screening for sarcopenia using the SARC-F questionnaire

·         Once screening is completed, the next step is assessment of muscle strength. This is either done by Chair stand test or by Handgrip strength assessment.

·         Confirmation of sarcopenia is done with the help of muscle quantity estimation. Bioelectrical Impedance Analysis (BIA) is used to estimate the total or appendicular skeletal muscle mass (ASM).

·         This confirmatory test is followed by assessing the severity of sarcopenia with performance tests including Short Physical Performance Battery (SPPB) as well as the Timed Up and Go test (TUG).

This will be followed by bedside administration of Mobility Disability Scale (MDS). Frailty will be assessed with FRIED Frailty index. 6 Minute Walk Test will be performed to assess function.

The participants will be followed up at 1, 3 and 6 months to collect information regarding any Major Adverse Cardiovascular Events (MACE) and mobility disability via MDS.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •ADHF in-patients ( Framingham criteria ) Diagnosed HF ( >1 year ) Age – no limit New York Heart Association (NYHA) class II – IV Corrected vision / normal vision Functionally ambulant.

排除标准

  • •Soft tissue injury in the past 1-3 months Fracture in lower extremities in the past 3-6 months Neurological conditions causing significant impairments like stroke Medically unstable patients (acute MI) Any medical disorder which precludes participation Short Blessed Test score > 7.

结局指标

主要结局

4. Bioelectrical Impedance Analysis

时间窗: On the date of discharge

SARCOPENIA

时间窗: On the date of discharge

Using the European Working Group on Sarcopenia in Older People (EWGSOP2) Algorithm consisting of

时间窗: On the date of discharge

1. Short Physical Performance Battery

时间窗: On the date of discharge

2. Timed Up and Go test

时间窗: On the date of discharge

3. SARC-F questionnaire

时间窗: On the date of discharge

次要结局

  • 1.6 Minute Walk Test(2.Mobility Disability Scale)
  • 1.Major Adverse Cardiovascular Events(2.Mobility Disability Scale)

研究者

发起方
Lakshman Iyer
申办方类型
Other [self]

研究点 (1)

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