MODERATE CONTINUOUS TRAINING VERSUS HIIT IN CANCER STADIUM II.
Condition: Cancer; Fatigue; Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

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.
    

Intervention name(s): Group continuous training at moderate intensity; Group high Intensity Interval Training; Group control
Intervention type(s): Other; Other; Other
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
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).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cancer; Aerobic exercise; High intensity training; Force