跳至主要内容
临床试验/NCT06297707
NCT06297707招募中不适用

Effect of Aquatic High Intensity Resistive Training on Cardiac Function and Exercise Capacity in Patients With Chronic Heart Failure

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月5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
60
试验地点
2
主要终点
Cardiac function

研究概览

简要总结

PURPOSE:

to evaluate effect of aquatic high intensity resistive training on cardiac function and exercise capacity in patients with chronic heart failure.

BACKGROUND:

Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of >37.7 million individuals globally. HF is a shared chronic phase of cardiac functional impairment secondary to many etiologies, and patients with HF experience numerous symptoms that affect their quality of life, including dyspnea, fatigue, poor exercise tolerance, and fluid retention.

详细描述

It is an interventional study in which 60 chronic heart failure patients estimated to enroll according to random allocation and divided into two groups. The experimental group participants will involve in aquatic high intensity resistive training sessions. The participants in the intervention group will receive 1 h of supervised lower limb aquatic resistance training three times a week for 12 weeks, for a total of 36 training sessions. Resistance of exercises will be progressed with three different levels: barefoot, small fins and large resistance boots and the training leg will perform all the movements without contact with the pool walls or bottom i.e., non-weight bearing. The intervention will be completed in small groups of 6-8 subjects in a pool heated to 30-32 with two instructors: one ensuring intensity and the other full range of movement. Intensity of the training sessions will be set at "as hard and fast as possible" to ensure maximal muscle contraction. Full range of motion will be strictly controlled for to ensure optimal movement of synovial fluid and exposure of the whole cartilage to the low compressive and shear forces created by the muscle contraction and movement. Training intensity will be monitored using heart rate monitors (Polar Electro Ltd, Kempele, Finland), rate of perceived exertion (RPE) using the Borg 6-20 scale and number of repetitions achieved per movement.

The control group will maintain usual care and will be asked to continue their usual leisure time activities. They will be offered the possibility of participating in two sessions consisting of 1 h of light stretching and relaxation during the 3-month intervention period.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ranges from 45 to 60 years old. Have chronic heart failure (NYHA class I to III).
  • Left ventricular ejection fraction (LVEF) > 50%
  • clinically stable with optimal pharmacological therapy in greater than three months
  • All patients didn't participate in any rehabilitation programs prior to the study.

排除标准

  • Signs of acute heart failure, unstable angina, or severe arrhythmia three months prior to enrolment in the study.
  • Pacemakers. recently diagnosed acute coronary syndrome or a recent coronary intervention or both renal insufficiency (estimated glomerular filtration rate < 30 mL/min) liver abnormalities uncontrolled hypertension moderate-to-severe valvular disease uncompensated heart failure patients Chronic lung disease. Other disorders counteracting exercise conditions that limit lower limb mobility (for example, burns, fractures)

结局指标

主要结局

Cardiac function

时间窗: 12 weeks

echocardiogram Left ventricular systolic dysfunction will be assessed using the ejection fraction by 2D simpson method (the percentage of the end diastolic volume ejected during systole

次要结局

  • exercise capacity(12 weeks)
  • physical symptoms of heart failure(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

marwa mahmoud elsayed mahmoud

assistant professor

Cairo University

研究点 (2)

Loading locations...

相似试验