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临床试验/NCT05846386
NCT05846386已完成不适用

Effects of Early Resistance Training on Functional Capacity and Electrocardiographic Changes Post Valve Replacement Surgery

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
P-R interval (in milliseconds)

研究概览

简要总结

Background: Recent recommendations from the European Society of Cardiology (ESC) are multidisciplinary cardiac rehabilitation including therapeutic exercises for patients after heart valve surgery unless there is insufficient evidence to decide whether therapeutic exercise cardiac training should be provided for such patients. As well, resistance training is an extremely safe systemic physical activity, and it has no contraindications if well-oriented, in addition to being the fastest-growing physical activity in the world in several practitioner settings.

Purpose: This study was conducted to investigate the effect of early resistance training on the fitness level (vo2 max) and (PR interval) of patients post-valve replacement surgery.

详细描述

Method: Forty males post-valve replacement surgery participants' age ranged from 20 to 30 years old and were selected randomly from National Heart Institute (Imbaba), this study was conducted in the period between April and November 2022, and those participants were allocated randomly into two equal groups twenty in each group. Group A received aerobic and resistance training three sessions per week for one-month, and group B received aerobic training three sessions per week for one month. All demographic data was recorded and an ECG device was used to record HR and R-P Intervals, Six-Minute Walk Test (6MWT) was used to assess of cardiorespiratory fitness for all participants in both groups (A&B)

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants' age ranged from 20 to 30 years old,
  • •Participants medically stable to do early resistance exercise in the first week after the operation.
  • •Each participant had undergone valve replacement surgeries only,
  • •Participants be able to do early resistance exercises in the first week after the operation.

排除标准

  • •The study excluded the participant if has one or more of the following criteria:
  • •sternal infection and delay sternal healing.
  • •Patient with a musculoskeletal condition limiting the ability to exercise or a geographical residence and/or lack of access to transportation, thus preventing exercise session attendance.
  • •The patient has an LV thrombus diagnosed by echocardiography, left ventriculogram, or other imaging.
  • •The patient is known to have unprotected left main coronary artery disease (CAD) greater than 50%.
  • •Patients have poor cognitive capabilities or poor mentality.
  • •Patient who had valve and CABG surgery.

研究组 & 干预措施

Aerobic and resistance training

Experimental

aerobic exercises (intervention) on arm ergometer and resistance training using weights for post valve replacement surgery patients for 4 weeks, 3 times/week for the duration of 45-70 min/ session.

干预措施: Resistance training (Behavioral)

Aerobic and resistance training

Experimental

aerobic exercises (intervention) on arm ergometer and resistance training using weights for post valve replacement surgery patients for 4 weeks, 3 times/week for the duration of 45-70 min/ session.

干预措施: Aerobic training (Behavioral)

Aerobic training

Active Comparator

aerobic exercises (intervention) on arm ergometer for post valve replacement surgery patients for 4 weeks, 3 times/week for the duration of 30-55 min/ session.

干预措施: Aerobic training (Behavioral)

结局指标

主要结局

P-R interval (in milliseconds)

时间窗: 4 weeks

represent a mortality index (the time from the beginning of atrial depolarization to the onset of ventricular depolarization) on the electrocardiograph

six minute walking distance (in meters)

时间窗: 4 weeks

represent aerobic capacity (distance walked in 6 min)

次要结局

未报告次要终点

研究者

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

Hady Atef Labib

Lecturer of physiotherapy for cardiovascular/respiratory disorders

Cairo University

研究点 (1)

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