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临床试验/NCT04407624
NCT04407624Unknown不适用

Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction

Dokuz Eylul University2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2019年10月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
34
试验地点
2
主要终点
Change in FVC

研究概览

简要总结

Cardiovascular diseases are a leading cause of death worldwide. According to the World Health Organization (WHO), cardiovascular diseases constitute 1/3 of all causes of death.

Myocardial infarction (MI) is an irreversible myocardial necrosis due to prolonged ischemia.

Patients with MI are candidates for cardiac rehabilitation (CR). American Heart Association (AHA) guidelines recommend exercise-based cardiac rehabilitation and suggest exercise to add to patients' routine treatment. When the literature on patients with MI is examined, various exercise programs are seen. The aims of present study is investigating and comparing the effectiveness of intermittent exercise training and aerobic exercise training programs in patients with MI.

详细描述

Cases are divided into two groups as exercise (control) and control group by closed envelope randomization method. All patients are informed about risk factors and risk factor management. All patients are trained 3 days in the first week under the supervision of a physiotherapist to learn individual exercise programs. Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Participants of the experimental group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study.

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
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having had MI at least 3 months ago
  • Stable clinical status for at least two weeks
  • Walking independently
  • Volunteer for research study

排除标准

  • Having unstable angina
  • Having uncontrolled hypertension
  • Having hemodynamic instability
  • Participating in any exercise program in the last six months
  • Having a major orthopedic or neurological problem that limits functionality

结局指标

主要结局

Change in FVC

时间窗: Baseline, 12th week

Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from lungs after taking the deepest breath possible, as measured by spirometry.

Change in FEV1/FVC

时间窗: Baseline, 12th week

Also known as Tiffeneau-Pinelli index, FEV1/FVC ratio is often used in diagnosing and treating lung diseases. The FEV1/FVC ratio is a measurement of the amount of air you can forcefully exhale from your lungs.

Change in PEF

时间窗: Baseline, 12th week

Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per minute or in liters per second.

Change in functional capacity

时间窗: Baseline, 12th week

Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance.

Change in peripheral muscle strength

时间窗: Baseline, 12th week

The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles. Quadriceps isometric muscle strength is measured with a Hand Held Dynamometer.

Change in respiratory muscle strength

时间窗: Baseline, 12th week

Measurement of respiratory muscle strength is useful in order to detect respiratory muscle weakness and to quantify its severity. Respiratory muscle strength is assessed by mouth pressures sustained for 1 s during maximal static manoeuvre against a closed shutter.

Change in FEV1

时间窗: Baseline, 12th week

FEV1 is the maximal amount of air which is forcefully exhale in one second. It is then converted to a percentage of normal predicted based on height, weight, and race.

次要结局

  • Change in body fat percentage(Baseline, 12th week)
  • Change in The Hospital Anxiety and Depression Scale(Baseline, 12th week)
  • Change in weight(Baseline, 12th week)
  • Change in severity of dyspnoea(Baseline, 12th week)
  • Change in The Fatigue Severity Scale(Baseline, 12th week)
  • Change in MacNew Heart Disease Health-Related Quality of Life instrument(Baseline, 12th week)
  • Change in body mass index(Baseline, 12th week)
  • Change in lean body mass(Baseline, 12th week)
  • Change in The International Physical Activity Questionnaire-short form(Baseline, 12th week)
  • Change in The Tampa Kinesiophobia Scale for Heart Patients(Baseline, 12th week)

研究者

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

Elvan Keles

Research Assistant

Dokuz Eylul University

研究点 (2)

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