MODERATE CONTINUOUS TRAINING VERSUS HIIT IN CANCER STADIUM II.

NCT ID: NCT03915288

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1573 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-02-28

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.

Conditions

Cancer; Fatigue; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group continuous training at moderate intensity

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).

Group Type: EXPERIMENTAL

Group continuous training at moderate intensity

Intervention Type: OTHER

70 minutes for intervention, where 10 minutes were warm up (breathing exercises, walking, stretching), 30 minutes of continuous aerobic training at moderate intensity (60-80% FCM), with fast walking or endless tread with the floor inclined to reach the desired intensity. Also on bicycle, rowing and elliptical; Then, 20 minutes of strength training (40-60% maximum strength) with dumbbells and theraban. Ends with 10 minutes of cooling with walking and breathing exercises.

Group high Intensity Interval Training

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%).

Group Type: EXPERIMENTAL

Group high Intensity Interval Training

Intervention Type: OTHER

70 minutes for intervention, where 10 minutes were for warm-up (Respiratory exercises, walking, stretching), 30 minutes 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 that we named 30-30. 30 seconds at moderate intensity (60-80% FCM) and 30 seconds at high intensity (80-90%). ; Then, 20 minutes of strength training (40-60% maximum strength) with dumbbells and theraban. Ends with 10 minutes of cooling with walking and breathing exercises.

Group control

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.

Group Type: ACTIVE_COMPARATOR

Group control

Intervention Type: OTHER

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.

Interventions

Group continuous training at moderate intensity

70 minutes for intervention, where 10 minutes were warm up (breathing exercises, walking, stretching), 30 minutes of continuous aerobic training at moderate intensity (60-80% FCM), with fast walking or endless tread with the floor inclined to reach the desired intensity. Also on bicycle, rowing and elliptical; Then, 20 minutes of strength training (40-60% maximum strength) with dumbbells and theraban. Ends with 10 minutes of cooling with walking and breathing exercises.

Intervention Type: OTHER

Group high Intensity Interval Training

70 minutes for intervention, where 10 minutes were for warm-up (Respiratory exercises, walking, stretching), 30 minutes 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 that we named 30-30. 30 seconds at moderate intensity (60-80% FCM) and 30 seconds at high intensity (80-90%). ; Then, 20 minutes of strength training (40-60% maximum strength) with dumbbells and theraban. Ends with 10 minutes of cooling with walking and breathing exercises.

Intervention Type: OTHER

Group control

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Tolteca

OTHER

Sponsor Role: lead

Responsible Party

Javier Eliecer Pereira Rodriguez

Physiotherapist, specialist in cardiopulmonary rehabilitation, magister in health sciences, university professor.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

JPereiraRodriguez

Identifier Type: -

Identifier Source: org_study_id