Impact of the Aerobic Exercise Versus Exercise of Force on the Hemodynamic, Lipidic, Anthropometric and Psychological Variables of Patients With Cardiac Failure

University Tolteca0 个研究点目标入组 920 人开始时间: 2016年4月1日最近更新: 2019年4月12日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 920
主要终点: Changes in the levels of Depression and Anxiety after 24 training sessions

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Introduction and objectives: At the global level, cardiovascular diseases are the leading cause of mortality. Currently, rehabilitation programs are shown as an effective treatment to mitigate the effects of heart failure. The main objective is to compare the effects of aerobic exercise and strength in patients with heart failure after a cardiovascular rehabilitation program.

Methods and materials: Randomized controlled trial over a period of 3 years with patients with heart failure distributed in 3 groups (Aerobic exercise, aerobic exercise plus upper limb -MMSS- training, aerobic exercise plus training of lower limb -MMII-). Blood samples were taken to determine blood glucose levels and lipid profile. In addition, tests for aerobic capacity, maximum heart rate, anthropometry, depression, anxiety, clinical and hemodynamic parameters. The tests were performed before and after 24 training sessions, 60 min, 3 times a week for two months.

详细描述

MATERIALS AND METHODS

This research for the group number 1 was retrospective and for groups 2 and 3 it was a randomized controlled trial with a basic probabilistic sampling by means of a table of random numbers, whose order was randomized through the Microsoft Excel 16.0 program, being the group experimental 1 at the end with 253 participants (aerobic exercise without strength training), 256 participants in experimental group 2 (aerobic exercise + strength training in the upper extremities) and control group with 255 (aerobic exercise + strength training for the lower extremities). The present investigation was carried out in a period of 3 years (April 2016-2019) that contains the following attributes:

Characteristics of the participants The participants contained similar characteristics from the point of view of: ejection fraction, functional class, glucose, lipid profile, muscle percentage, fat and BMI (body mass index), abdominal circumference, overweight, obesity, prevalence of diabetes, arterial hypertension (HTA), kidney disease, cardiovascular risk factors and cardiovascular surgical procedure for their respective analysis. In addition, all participants presented "High risk" according to the stratification proposed by the American Association of Cardiopulmonary Rehabilitation. Highlighting that for group 1 their research methodology was retrospective through the collection of data from medical records of the year 2000 and groups 2 and 3 were interventions with methodology of randomized clinical trial between the years 2016 to 2019.

Criteria for inclusion in the study The patients had to be post-operative of cardiovascular surgery that go to a phase II cardiac rehabilitation program, which at the time had to sign an informed consent endorsed by the ethics and research committee of the institution. Likewise, it was necessary for participants to have heart failure with ejection fraction greater than 35%; do not have any inconvenience when doing the questionnaires, tests and measures that the investigation demands, and a commitment to go 3 times a week for RCV.

Exclusion criteria Patients who had severe pain in the lower limbs, unstable angina, heart rate >120 bpm (beats per minute) at rest, systolic blood pressure >190 mmHg, diastolic blood pressure >120 mmHg were discarded. Similarly, patients who had a positive contraindication item for cardiac rehabilitation were not admitted in the study. In addition, the participant had the option of being able to withdraw from the research when he wished or to show hemodynamic instability without improving during any test or during the intervention process.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Participants in the cardiac rehabilitation program.
•To sign an informed consent endorsed by the ethics and research committee of the institution.
•Participants with heart failure with ejection fraction greater than 35%
•Participants do not have any inconvenience when doing the questionnaires, tests and measures that the investigation demands,
•Participants than will can to go 3 times a week for Cardiovascular rehabilitation.

排除标准

•Participants who had severe pain in the lower limbs.
•Unstable angina.
•Heart rate >120 bpm (beats per minute) at rest.
•Systolic blood pressure >190 mmHg.
•Diastolic blood pressure >120 mmHg.
•Participants who had a positive contraindication item for cardiac rehabilitation were not admitted in the study.
•Participants to show hemodynamic instability without improving during any test or during the intervention process.

研究组 & 干预措施

Group 1 (Medical record)

Active Comparator

For group 1, participants do not have intervention as groups 2 and 3. This group consists of reviewing the medical history of the year 2000 to determine the variables of the study and then compare them with groups 2 and 3. This group of participants they were from the year 2000 and whose information will be strictly taken from their medical history was based on initial training with warm-up and walking, after that, aerobic training was performed from 50 to 70% of their maximum heart rate and they finished their session training with breathing exercises, coordination, balance and walking.

干预措施: Aerobic exercise more force (Other)

Group 2: Aerobic exercise + Strength training in MMSS

Experimental

For group 2, participants begin their training with warm-up and walking, after that, performed aerobic exercise in endless band and elliptical bike more strength exercises for upper limbs with dumbbells, multi-strength equipment and Theraband.

The prescription of aerobic exercise was given from 50 to 70% of your maximum heart rate and for strength, between 30% to 50% of 1 RM was determined, prolonging a percentage of heart rate that did not surpass 70% of the FCM nor the subjective uptake of physical effort to more than 6 on the modified Borg scale.

干预措施: Aerobic exercise more force (Other)

Group 3: Aerobic exercise + Strength training in MMII

Experimental

For group 3, participants begin their training with warm-up and walking, after that, performed aerobic exercise in endless band and elliptical bike more the strength training for lower limbs with theraband, multi-strength equipment and exercises for activation of the sole-twin pump.

干预措施: Aerobic exercise more force (Other)