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临床试验/NCT02571270
NCT02571270已完成不适用

Impact Of Supervised 12-Week-Combined Physical Training In Heart Failure Patients: A Randomized Trial

Universidade Estadual Paulista Júlio de Mesquita Filho0 个研究点目标入组 28 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
主要终点
Questionnaire about quality of life

研究概览

简要总结

Purpose: Physical exercise exerts favorable impact on functional capacity (FC) and quality of life (QL) in patients with heart failure (HF). It is believed that the combined aerobic and resistance physical training (CPT) supervised by physical educator is better than only prescription of unsupervised exercise. The aim of this study is to compare the effects of a CPT program on the FC and QL of HF patients with reduced ejection fraction (HFREF) with the practice medical routine prescription of regular physical activity and correlate these findings with clinical and echocardiographic variables.

Methods: A longitudinal prospective study included 28 consecutive HFREF patients randomly divided in two age- and gender- matched groups: Trained Group (TG, n = 17), patients undergoing 12 weeks of supervised CPT and Non Trained Group (NTG, n = 11), patients receiving only medical prescription to practice regular physical exercise. All patients were submitted to clinical evaluation, transthoracic echocardiography, Cooper walk test and QL questionnaire before and after the study protocol. Student t test or Mann-Whitney test were performed for groups comparison and correlation tests for the same group variable associations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients with heart failure with LVEF <50%;
  • Patients with optimized drug therapy;
  • Age over 18 years.

排除标准

  • Heart failure NYHA class IV and/or Stage D;
  • Decompensated HF in the last three months;
  • Atrial fibrillation and/or implantable device at the moment of inclusion;
  • Patients with chronic obstructive pulmonary disease (COPD);
  • Patients with biomechanical limitations of physical activity.

结局指标

主要结局

Questionnaire about quality of life

时间窗: up to 12 weeks of research

Cardiorespiratory evaluation (VO2 in Mets)

时间窗: up to 12 weeks of research

Morphological echocardiographic variables (mm)

时间窗: up to 12 weeks of research

Sistolic Function echocardiographic variables (Percentage)

时间窗: up to 12 weeks of research

Diastolic Function echocardiographic variables (cm/s)

时间窗: up to 12 weeks of research

次要结局

  • Anthropometric measurements (cm)(up to 12 weeks of research)
  • Body composition (%fat percentage)(up to 12 weeks of research)
  • Presence of comorbidities(up to 12 weeks of research)
  • Blood pressure measurement (mmHg)(up to 12 weeks of research)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tainá Fabri

Master's degree

Universidade Estadual Paulista Júlio de Mesquita Filho

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