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临床试验/NCT07245459
NCT07245459已完成不适用

The Effect of a Cardiac Rehabilitation Program Including Moderate-Intensity Continuous Exercise Training and High-Intensity Interval Exercise Training on Sarcopenia and Myokines in Patients With Heart Failure

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年8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
22
试验地点
1
主要终点
VO2 max

研究概览

简要总结

In this study, it is aimed to investigate the effects of a cardiac rehabilitation program consisting of two different aerobic exercise modalities on aerobic capacity, symptoms, quality of life, and sarcopenia in patients with heart failure who present with one or more symptoms such as dyspnea, difficulty walking, muscle weakness, or limitations in activities of daily living and who are in need of cardiac rehabilitation.

详细描述

Patients who were followed up in the Heart Failure Clinic, aged 18-75, had stable clinical symptoms, and were referred to Cardiopulmonary Rehabilitation Unit for the cardiac rehabilitation program and met the inclusion criteria will be included in our study.

Prior to initiating the program, participants will be prescribed an individualized exercise regimen determined to be both effective and safe, based on their exercise capacity assessed through the CPET-derived optimal exercise prescription. For the MCT group, the program includes a 5-minute warm-up at 30% of VO₂max, followed by 20 minutes of continuous exercise at 60% of VO₂max, and a 5-minute cool-down at 30% of VO₂max.

For the HIIT group, the first week consists of three sessions including a 5-minute warm-up at 30% of VO₂max, 20 minutes of exercise at 60% of VO₂max, and a 5-minute cool-down at 30% of VO₂max. Starting from the second week, interval training will be implemented as follows: 5 sessions of 20 minutes with intervals alternating between 65-80% of VO₂max for 60 seconds and 50% of VO₂max for 120 seconds; 5 sessions of 20 minutes alternating 65-80% of VO₂max for 120 seconds and 50% of VO₂max for 120 seconds; and 5 sessions of 20 minutes alternating 65-80% of VO₂max for 240 seconds and 50% of VO₂max for 180 seconds.

Both groups will be completed a total of 18 sessions over 6 weeks, with training occurring three times per week. Resistance training exercises will be incorporated into the programs in both groups after the second week. Load increments of 5 watts will be applied based on patient tolerance.

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 (Participant)

盲法说明

The patients will be blinded to group allocation, and the exercise group will be determined through randomization, after which the appropriate program will be administered accordingly.

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
否

入选标准

  • •Patients aged 18-75 years heart failure (HF) NYHA class II-III left ventricular ejection fraction (LVEF) <0.40, BMI between 18-30 kg/m² standard medications at stable doses for at least two weeks prior to enrollment

排除标准

  • •a history of cardiac implant device placement within the previous 6 weeks a planned cardiac device implantation heart transplantation within the next 12 months acute coronary syndrome within the prior 6 weeks severe valvular or congenital heart disease severe hypertrophic obstructive cardiomyopathy acute myocarditis or pericarditis intracardiac thrombus primary pulmonary hypertension peripartum cardiomyopathy uncontrolled hypertension (systolic blood pressure >200 mmHg and/or diastolic blood pressure >110 mmHg) severe arrhythmias.

研究组 & 干预措施

HIIT (high intensity interval training)

Experimental

For the HIIT group, the first week consists of three sessions including a 5-minute warm-up at 30% of VO₂max, 20 minutes of exercise at 60% of VO₂max, and a 5-minute cool-down at 30% of VO₂max. Starting from the second week, interval training will be implemented as follows: 5 sessions of 20 minutes with intervals alternating between 65-80% of VO₂max for 60 seconds and 50% of VO₂max for 120 seconds; 5 sessions of 20 minutes alternating 65-80% of VO₂max for 120 seconds and 50% of VO₂max for 120 seconds; and 5 sessions of 20 minutes alternating 65-80% of VO₂max for 240 seconds and 50% of VO₂max for 180 seconds.

干预措施: HIIT (high intensity interval training) (Other)

MCT (moderate intensity continuous training)

Experimental

For the MCT group, the program will be included a 5-minute warm-up at 30% of VO₂max, followed by 20 minutes of continuous exercise at 60% of VO₂max, and a 5-minute cool-down at 30% of VO₂max.

干预措施: MCT (moderate intensity continuous training) (Other)

结局指标

主要结局

VO2 max

时间窗: Day 1 and 6th week

The maximal oxygen uptake (VO2max) in Cardiopulmonary exercise test (CPET)

次要结局

  • Myostatin(Day 1 and 6th week)
  • BDNF(Day 1 and 6th week)

研究者

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

Ebru Alemdaroğlu

Ankara Bilkent City Hospital

Ankara City Hospital Bilkent

研究点 (1)

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