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临床试验/NCT06032780
NCT06032780招募中不适用

Effects of Eccentric Resistance Training on Ventricle Functions and Aerobic Capacity Among Individuals With Chronic Heart Failure

Riphah International University4 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
84
试验地点
4
主要终点
Aerobic Capacity

研究概览

简要总结

To determine the effects of eccentric resistive training on ventricle functions and aerobic capacity as compared to a resistance and aerobic training among Heart failure (HF)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Group allocation will be kept blinded to the assessor and to the treatment provider (trained physical therapist).

入排标准

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

入选标准

  • Diagnosis of Chronic HF and currently stable with optimal medical therapy
  • Chronic Heart failure with ejection fraction > 30 %
  • Patient able to safely perform lower limb exercise will be check by six- minute walk test (6 MWT)

排除标准

  • Those Heart failure patient whose are in acute phase or planed for any immediate medical intervention
  • Already participating in cardiac rehabilitation
  • New York Heart Association (NYHA) Classification of HF class IV HF symptoms
  • Co-existent other disease such as asthma/ COPD/interstitial lung disease.
  • Symptomatic Second degree or third degree heart block.
  • ECG with uncontrolled ventricular arrhythmia
  • Limited Exercise ability due to neurologic or orthopedic impairments of the legs (will cross-check with 6 MWT)

结局指标

主要结局

Aerobic Capacity

时间窗: 12 week

Changes will be measured at baseline, 4th week, 8th week and 12th week. The 6-min walk test provides an indirect measure of cardiovascular functional/aerobic capacity. Six Minute Walk test (6MWT) will be used to assess the functional capacity of the individuals with HF. The subjects will be instructed to walk for 6 minutes at a given time along a 30-m line at an interval of 1.5 m in an outdoor corridor, and the distance walked will be recorded in meters. The participants will be encouraged to continue walking as fast as possible. Then a generalized equation will be used to predict peak VO2 from 6 minute walk distance (6MWD) with the help of formula. Mean Peak VO2 (ml/kg/Mean) = 4.948 + 0.023 \*Mean 6MWD (meters)

Ventricle Functions

时间窗: 12 week

Changes from the baseline will be measured. Doppler resting echocardiography will be performed to measure ventricle functions. Standard views, including the parasternal long-axis, short-axis at the papillary muscle level, and apical 4- and 2-chamber views will be recorded. Left ventricular ejection fraction (LVEF) and end systolic and end-diastolic diameters (LVESD and LVEDD) will be measured using formula (Tiecholz formula i-e spherical volume of the heart multiplied by a correction factor). Any structural changes will also be recorded.

次要结局

  • Quality of life (Minnesota Living with Heart Failure Questionnaire)(12 week)
  • Maximal strength of respiratory muscles(12 week)
  • Cardiac Risk Factors - Blood Pressure(12 week)
  • Cardiac Risk Factors - Body mass index(12 week)
  • Strength(12 week)
  • Peak Expiratory Flow (PEF)(12 week)
  • Forced Expiratory Volume in 1 second (FEV1)(12 week)
  • Forced vital Capacity (FVC)(12 week)
  • Cardiac Risk Factors - Lipid profile(12 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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