MODERATE CONTINUOUS TRAINING VERSUS HIIT ON CARDIOMETABOLIC AND PSYCHOSOCIAL VARIABLES IN CANCER STADIUM II.CONTROLLED RANDOMIZED TRIAL

University Tolteca0 个研究点目标入组 1,573 人开始时间: 2015年11月1日最近更新: 2019年4月16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: 1,573
主要终点: Changes in the levels of force after 36 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: Exercise programs focused on moderate intensity continuous training (MICT) and HIIT (High Intensity Interval Training) are shown as an effective treatment to mitigate the effects of cancer.

Objective: To determine and compare the effects of MICT vs. HIIT on the cardiometabolic and psychosocial variables of the cancer patient.

Methods and materials: Randomized controlled trial of 3 years and 4 months in participants with stage II cancer divided into 3 groups (MICT, HIIT and control group). Risk factors, blood samples for glycemia and lipid profile were identified. In addition, 6-minute walk, stress test for maximum heart rate (HRM), anthropometry, quality of life, fatigue, sarcopenia, depression, anxiety, clinical and hemodynamic parameters. All tests were done before and after 36 training sessions of 70 minutes, 3 times a week.

详细描述

MATERIALS AND METHODS

This investigation was a randomized clinical trial, which included the participants with stage II cancer who were randomly assigned to the MICT group (Experimental Group 1), HIIT (Experimental Group 2) or group of usual considerations (Control Group). The present, was distributed with a basic probabilistic sampling by means of a table of random numbers, whose order was randomized through the program Microsoft Excel 16.0, being the experimental group 1 with 270 participants (MICT + strength training), 275 participants in experimental group 2 (HIIT + strength training) and control group with 267 (verbal recommendations on exercise, diet, follow-up via telephone call and carrying out activities of daily living). The execution period was 3 years and 4 months (November 2015 - February 2019) to obtain the following attributes:

Characteristics of the participants The participants contained similar characteristics from the point of view of: Cancer stage, ejection fraction, functional class, glucose, lipid profile, muscle percentage, fat and BMI (body mass index), abdominal circumference, overweight, obesity, prevalence of diabetes, hypertension (HBP), cardiovascular risk factors and in some cases surgical intervention. In addition, all participants presented "High risk" according to the stratification proposed by the American Association of Cardiopulmonary Rehabilitation.

Blind methodology A simple blind clinical study was carried out, in which the participants were initially evaluated by a non-investigating professional (oncology doctor of the Oncology service). Subsequently, the participants accessed a database in Microsoft Excel 16.0 exclusively with an identification number that allowed the blinding of the investigators. As they were entering the randomized clinical trial, he/she was randomly located in one of the three groups (MICT-HIIT-GC), according to how the computer generated the group location sequence. All participants and professionals, including researchers, were blinded throughout the protocol.

For groups 1 and 2 (MICT-HIIT), the investigators prepared the questionnaires and tests without them knowing the assignment of each patient. For experimental groups 1 and 2, the evaluating authors were D. P-F. - C. Q-G .; and X. V-B. - K. S-P. respectively.

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: 否

入选标准

•Participants with cancer stadium II
•To sign an informed consent endorsed by the ethics and research committee of the institution.
•Participants 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 or upper 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 make exercise 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 continuous training at moderate intensity

Experimental

Training program lasting 36 weeks with assistance 3 times a week with 70 minutes per intervention, where 10 minutes were warm up (breathing exercises, walking, stretching), 30 minutes of continuous aerobic training at moderate intensity - MICT (60 -80% FCM), 20 minutes of strength training (40-60% maximum strength) with dumbbells and theraban. And the last 10 minutes were for cooling (exercises coordination, balance, walking and breathing exercises).

Regarding the MICT training, this was done with fast walk or jog in endless band with the floor tilted to reach the desired intensity. Also by bicycle, rowing and elliptical. During the entire intervention the participants was monitored by a Polar Multisport RS800CX, oximetry and with the Borg scale to avoid exceeding the training intensity (60-80% FCM, 6 to 8 Borg).

干预措施: Group continuous training at moderate intensity (Other)

Group high Intensity Interval Training

Experimental

Training program lasting 36 weeks with assistance 3 times a week with 70 minutes per intervention, where 10 minutes were warm up (breathing exercises, walking, stretching), 30 minutes of continuous aerobic training at moderate intensity (60 -80% FCM), 20 minutes of strength training (40-60% maximum strength) with dumbbells and theraban. And the last 10 minutes were for cooling (exercises coordination, balance, walking and breathing exercises).

Concerning the HIIT training, it consisted of an intensity of interval training. That is, the participants who underwent 30 minutes of aerobic exercise consisted of a protocol created for this experimental group, which we named 30-30. 30 seconds at moderate intensity (60-80% FCM) and 30 seconds at high intensity (80-90%).

干预措施: Group high Intensity Interval Training (Other)

Group control

Active Comparator

This group did not perform supervised exercise nor were they given exercise recipes or formal intervention programs. Only continued with the usual care and gave directions to maintain a healthy lifestyle based on proper nutrition and usual activities. It is highlighted that in the institutions where the patients of the 3 groups attended, there is not a physical training area supervised by a professional. Therefore, the intervention protocol was not excluded or denied to the participants of the control group, but continuity and supervision was given for investigative purposes to its process and treatment. In addition, none of the 3 groups stopped their medical treatment or that of the other professionals that make up the interdisciplinary team.

干预措施: Group control (Other)