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MODERATE CONTINUOUS TRAINING VERSUS HIIT IN CANCER STADIUM II.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915288
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Javier Eliecer Pereira Rodriguez, University Tolteca

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.


Condition or disease Intervention/treatment Phase
Cancer Fatigue Sarcopenia Other: Group continuous training at moderate intensity Other: Group high Intensity Interval Training Other: Group control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1573 participants
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
Official Title: MODERATE CONTINUOUS TRAINING VERSUS HIIT ON CARDIOMETABOLIC AND PSYCHOSOCIAL VARIABLES IN CANCER STADIUM II.CONTROLLED RANDOMIZED TRIAL
Actual Study Start Date : November 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: 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).

Other: 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.

Experimental: 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%).

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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Changes in ejection fraction after 36 training sessions (%) [ Time Frame: After 3 month of training (36 training sessions) ]
    it is the most important measure of cardiac functioning. This value, expressed as a percentage, measures the decrease in the volume of the left ventricle of the heart in systole, with respect to the diastole. The normal values are higher than 45%.

  2. Changes of the maximum heart rate in a effort test after 36 training sessions [ Time Frame: After 3 month of training (36 training sessions) ]
    It is the maximum capacity that the heart has to contract and we determine it by means of an effort test. The Maximum heart rate can be determined by formula or in a effort test (In the present investigation) which consists in mounting the participant in an endless band with an inclination and speed determined according to the protocol for said test. The test is stopped when the participant. indicates that it can not be more or there are electrocardiographic alterations that indicate that it is the participant's maximum.

  3. Changes in the Body weight after 36 training sessions (Kg) [ Time Frame: After 3 month of training (36 training sessions) ]
    How much body weight (kg) pre and post intervention

  4. Changes in the Body Mass Index after 36 training sessions (%) [ Time Frame: After 3 month of training (36 training sessions) ]
    it is a mathematical reason that associates the mass and the size of an individual. it is also known as the Quetelet index. This result is determined by the formula of weight/square size.

  5. Changes in the Abdominal circumference after 36 training sessions (cm) [ Time Frame: After 3 month of training (36 training sessions) ]
    It is the measurement of the distance around the abdomen at a specific point. Abdominal circumference is used to diagnose and monitor abdominal obesity. The values are in centimeters and according to the population to be studied, the measurements must be less than 90cm for men and 80cm for women.

  6. Changes in the Fat percentage after 36 training sessions (%) [ Time Frame: After 3 month of training (36 training sessions) ]
    Percentage of body fat is considered a measure to determine the level of body fat and a high percentage is a risk factor that triggers multiple chronic diseases. This measure can be determined in many ways but in our study it was used by means of bioimpedance. The normal values for men and women depend on the age of the patients and the manufacturer of the scale.

  7. Changes in the Muscle percentage after after 36 training sessions (%) [ Time Frame: After 3 month of training (36 training sessions) ]
    Muscle percentage is considered a measure to determine the level of muscle in the body and a low percentage is a risk factor that indicates sarcopenia and is associated with a decrease in quality of life. This measure can be determined in many ways but in our study it was used by means of bioimpedance. The normal values for men and women depend on the age of the patients and the manufacturer of the scale.

  8. Changes in the levels of Depression and Anxiety after 36 training sessions [ Time Frame: After 3 month of training (36 training sessions) ]
    Psychological alteration that can be determined by the "Hospital Anxiety and Depression Scale". This scale consists of a series of questions for depression and others for anxiety. The final grade is in the range of 1 to 10 and for the diagnosis of depression or anxiety the result must be greater than or equal to 8.

  9. Changes in the levels of force after 36 training sessions [ Time Frame: After 3 month of training (36 training sessions) ]
    Strength is the physical ability to perform a job or a movement. It can be assessed with 1 maximum repetition and the maximum weight the participant manages to lift will be the reference value for his prescription. In addition, muscle strength can be assessed by dynamometry and indicates low, normal or high muscle strength. Their values depend on the age and sex of the participant.

  10. Changes in the levels of Sarcopenia after 36 training sessions [ Time Frame: After 3 month of training (36 training sessions) ]

    Sarcopenia is the degenerative loss of muscle mass and strength as you get older. It is of high prevalence in patients with cancer. Sarcopenia is assessed according to the European Consensus on Sarcopenia (2010) who presented a diagnostic algorithm based on three criteria. Exploration of gait, muscle strength and muscle mass.

    For the first criterion, we use the Short Physical Performance Battery (SPPB). For the second criterion, the muscular strength, the dynamometry test is used (See force section). And in a final criterion, the muscle mass was assessed using the body mass index and the circumference of the calf, taking as a cut-off point the 31 cm.


  11. Changes in the levels of Fatigue after 36 training sessions [ Time Frame: After 3 month of training (36 training sessions) ]
    Fatigue was assessed using the FACT-Fatigue Scale Scale (Fatigue Scale of the Functional Evaluation of Cancer Therapy), which is an inventory of 13 items that assesses the severity of cancer-associated fatigue (FAC) in the last week. with a scale of 0 to 4 and that with higher scores reflect a lower FAC.

  12. Changes in the levels of Quality of life after 36 training sessions [ Time Frame: After 3 month of training (36 training sessions) ]
    For the quality of life, it is necessary to use the questionnaire called EORTC QLQ-C30 (Version 3), which has 30 questions, where each question will go with a score of 1 to 4 and the higher the final result the better the quality of life. participant's life

  13. Changes in the levels of Total cholesterol after 36 training sessions (mg/dl) [ Time Frame: After 3 month of training (36 training sessions) ]
    It is part of the measures to determine the lipid profile of a person and serves to determine different types of dyslipidemia. This item is obtained by means of a blood sample analyzed in a clinical laboratory and the result obtained by a professional for this purpose. Values above 200 mg/dl are indicative of a lipid alteration.

  14. Changes in the levels of Triglycerides after 36 training sessions (mg/dl) [ Time Frame: After 3 month of training (36 training sessions) ]
    It is part of the measures to determine the lipid profile of a person and serves to determine different types of dyslipidemia. This item is obtained by means of a blood sample analyzed in a clinical laboratory and the result obtained by a professional for this purpose. Values above 150 mg/dl are indicative of a lipid alteration.

  15. Changes in the levels of LDL after 36 training sessions (mg/dl) [ Time Frame: After 3 month of training (36 training sessions) ]
    It is part of the measures to determine the lipid profile of a person and serves to determine different types of dyslipidemia. This item is obtained by means of a blood sample analyzed in a clinical laboratory and the result obtained by a professional for this purpose. Values above 100 mg/dl are indicative of a lipid alteration.

  16. Changes in the levels of HDL after 36 training sessions (mg/dl) [ Time Frame: After 3 month of training (36 training sessions) ]
    It is part of the measures to determine the lipid profile of a person and serves to determine different types of dyslipidemia.This item is obtained by means of a blood sample analyzed in a clinical laboratory and the result obtained by a professional for this purpose. Values lower than 40 mg/dl are indicative of a lipid alteration.

  17. Changes in the levels of Glucose after 36 training sessions (mg/dl) [ Time Frame: After 3 month of training (36 training sessions) ]
    It is used to determine blood glucose levels and its high values are indicative for diabetes mellitus. This item is obtained by means of a blood sample analyzed in a clinical laboratory and the result obtained by a professional for this purpose. Values lower than 126 mg/dl are indicative of diabetes mellitus.


Secondary Outcome Measures :
  1. Changes in the Estimated maximum oxygen volume after 36 training sessions (ml/kg/min) [ Time Frame: After 3 month of training (36 training sessions) ]
    It is the maximum amount of oxygen that the body can absorb, transport and consume in a given time, is the blood that our body can transport and metabolize. To determine the Vo2 values, the 6-minute walking test is used and to determine the result of the test, formulas are used according to the meters traveled, age, sex, height and weight of the participant. The larger the meters traveled, the greater the vo2.

  2. Changes in the unit of measurement of the metabolic index (METs) after 36 training sessions (ml/kg/min) [ Time Frame: After 3 month of training (36 training sessions) ]
    It is the unit of measurement of the metabolic index (amount of energy consumed by an individual in a resting situation). To determine the METs values, the 6-minute walking test is used and to determine the result of the test, formulas are used according to the meters traveled, age, sex, height and weight of the participant. The larger the meters traveled, the greater the METs.

  3. Changes in the Distance traveled after 36 training sessions (m) [ Time Frame: After 3 month of training (36 training sessions) ]
    Distance traveled in this of 6 minute walk test. The larger the meters traveled, this will indicate better Vo2, METs and aerobic and physical capacity in the participant.

  4. Changes in the Dyspnoea after 36 training sessions [ Time Frame: After 3 month of training (36 training sessions) ]
    Dyspnea is a respiratory difficulty that usually translates into shortness of breath. Dyspnea can be determined using the original Borg scale (Score from 0 to 20) or modified (Score from 0 to 10), in which the higher the number indicated by the participant, the higher the degree of dyspnea.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Javier Eliecer Pereira Rodriguez, Physiotherapist, specialist in cardiopulmonary rehabilitation, magister in health sciences, university professor., University Tolteca
ClinicalTrials.gov Identifier: NCT03915288    
Other Study ID Numbers: JPereiraRodriguez
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Initially, it is an issue that depends on the hospital institution where the research was conducted due to the personal data of the patients and the confidentiality of the institution. Therefore, initially it would be to talk with the patients, the institution and all the researchers. Mainly with the clinic because it is a bit jealous with your information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javier Eliecer Pereira Rodriguez, University Tolteca:
Cancer
Aerobic exercise
High intensity training
Force
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical