Clinical trial NCT03915288: MODERATE CONTINUOUS TRAINING VERSUS HIIT IN CANCER STADIUM II.
Official title: MODERATE CONTINUOUS TRAINING VERSUS HIIT ON CARDIOMETABOLIC AND PSYCHOSOCIAL VARIABLES IN CANCER STADIUM II.CONTROLLED RANDOMIZED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Fatigue
Sarcopenia
Keywords: Cancer
Aerobic exercise
High intensity training
Force
Lead sponsor: University Tolteca
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 1573
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1573 cancer patients, who, after the exclusion criteria, 812 patients with stage II cancer finally started the investigation and were organized into 3 groups. 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).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

After the tests, the participants were suggested to approach the main investigator (J. P-R) to inform them of their schedule and the start date of the training program. However, we emphasize that from the initial exams until the end of the training program, the authors did not establish a conversation on the subject with the participants or the therapists. Exclusively, the investigators carried out questionnaires, tests and pre and post-training tests and alone, the investigator J. P-R. held regular meetings with the physiotherapists trainers to know and harmonize the training of each group, but not to intimate with the participants or review their data.

After the training program, tests and examinations were performed on the patients of each group to calculate the changes after the training. Taking into account the information gathered before and after, the statistical analyzes for experimental group 1 were carried out by X. V-B. and K. S-P .; for experimental group 2 by D. P-F. and C. Q-G. and for the control group, the investigators J. P-R. and E. G-D. Finally, once the different variables were studied blindly, all the investigators were informed about the groups with their corresponding participants and the results to generate the conclusions all together.

Anthropometric characteristics In all the participants the following data were obtained: Family and personal background using a self-created questionnaire. Also, anthropometric measures (weight, height, body mass index, abdominal circumference, percentage of fat and muscle) using standardized techniques in the Mexican population.

Weight, percentage of fat and muscle were obtained using the digital scale previously calibrated and located on a flat and stable surface, using the indications of the user manual. On the other hand, the height was obtained with a tallimeter placing the participants standing, with the head in the Frankfort plane and the shoulders relaxed to avoid the lordosis and the lower limbs completely against the wall. Having said the above, with these variables the BMI was determined in kg/m-1. Then, with a tape measure and a precision of 1 mm, the measurement of the abdominal circumference was collected.

Clinical and hemodynamic parameters After all the above procedures, blood glucose levels were determined on the first and last day of your training session. The blood sample was taken between 7:00 and 8:00 a.m., after 8-10 hours of fasting. This same sample served to define the levels of cholesterol, triglycerides, low density lipoproteins (LDL) and high density lipoproteins (HDL). In addition, each patient underwent a 2-D (two-dimensional) echocardiography before and after the training program, to visualize the structures, left ventricular ejection fraction (LVEF) and analyze their mobility in real time. In this same evaluation, the functional class of each patient was identified according to the NYHA classification (New York Heart Assosiation); which designates 4 classes (I, II, III and IV) based on the limitations of the participant's physical activity, caused by cardiac symptoms. Similarly, perceived dyspnea and exertion were assessed using the modified Borg scale. The heart rate was detected by the Polar Multisport RS800CX system and the respiratory one, as the systolic and diastolic blood pressure were obtained manually, while the oxygen saturation was obtained with a portable oximeter.

Questionnaires and tests From the beginning, the participants underwent a medical evaluation in the oncology area to understand the participant's current status, sociodemographic, anthropometric and physiological characteristics. On the same day, it was assessed by physiatry and physiotherapy to estimate exercise tolerance through the 6-minute walk test, which was superimposed before and after the 36 training sessions. The protocol for the 6-minute walk test was conducted in accordance with the ATS Statement: Guidelines for the six-minute walk test of the American Thoracic Society.

After this evaluation day, the participants had to return the following day to perform an exercise test according to the Naughton protocol, which is recommended in high-risk patients and whose velocity and inclination in the endless band is by stages 2 minutes. The investigators emphasize that for these tests, the participants was told that he should avoid smoking, drinking drinks or any type of medication that could alter his vital signs or performance during the test.

Ethical considerations The design and development of the research was carried out under the ethical considerations of the Declaration of Helsinki, signature informed consent and under the authorization of the participants, managers, coordinators and ethics committee of the institution.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in ejection fraction after 36 training sessions (%)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes of the maximum heart rate in a effort test after 36 training sessions
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the Body weight after 36 training sessions (Kg)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the Body Mass Index after 36 training sessions (%)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the Abdominal circumference after 36 training sessions (cm)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the Fat percentage after 36 training sessions (%)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the Muscle percentage after after 36 training sessions (%)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of Depression and Anxiety after 36 training sessions
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of force after 36 training sessions
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of Sarcopenia after 36 training sessions
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of Fatigue after 36 training sessions
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of Quality of life after 36 training sessions
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of Total cholesterol after 36 training sessions (mg/dl)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of Triglycerides after 36 training sessions (mg/dl)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of LDL after 36 training sessions (mg/dl)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of HDL after 36 training sessions (mg/dl)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the levels of Glucose after 36 training sessions (mg/dl)
timeFrame: After 3 month of training (36 training sessions)
Secondary outcomes:
measure: Changes in the Estimated maximum oxygen volume after 36 training sessions (ml/kg/min)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the unit of measurement of the metabolic index (METs) after 36 training sessions (ml/kg/min)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the Distance traveled after 36 training sessions (m)
timeFrame: After 3 month of training (36 training sessions)
measure: Changes in the Dyspnoea after 36 training sessions
timeFrame: After 3 month of training (36 training sessions)
Other outcomes:
Locations:
Study officials:
References: