MODERATE CONTINUOUS TRAINING VERSUS HIIT IN CANCER STADIUM II.

NCT03915288 | Completed DMC

• 1 other identifier: JPereiraRodriguez
• Study Type: interventional
• Target: 1,573
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer; Fatigue; Sarcopenia

Keywords

Cancer; Aerobic exercise; High intensity training; Force

Outcome Measures

Primary Outcomes (17)

• Changes in ejection fraction after 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%.

  After 3 month of training (36 training sessions)

• Changes of the maximum heart rate in a effort test after 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.

  After 3 month of training (36 training sessions)

• Changes in the Body weight after 36 training sessions (Kg)

  How much body weight (kg) pre and post intervention

  After 3 month of training (36 training sessions)

• Changes in the Body Mass Index after 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.

  After 3 month of training (36 training sessions)

• Changes in the Abdominal circumference after 36 training sessions (cm)

  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.

  After 3 month of training (36 training sessions)

• Changes in the Fat percentage after 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.

  After 3 month of training (36 training sessions)

• Changes in the Muscle percentage after after 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.

  After 3 month of training (36 training sessions)

• Changes in the levels of Depression and Anxiety after 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.

  After 3 month of training (36 training sessions)

• Changes in the levels of force after 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.

  After 3 month of training (36 training sessions)

• Changes in the levels of Sarcopenia after 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.

  After 3 month of training (36 training sessions)

• Changes in the levels of Fatigue after 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.

  After 3 month of training (36 training sessions)

• Changes in the levels of Quality of life after 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

  After 3 month of training (36 training sessions)

• Changes in the levels of Total cholesterol after 36 training sessions (mg/dl)

  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.

  After 3 month of training (36 training sessions)

• Changes in the levels of Triglycerides after 36 training sessions (mg/dl)

  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.

  After 3 month of training (36 training sessions)

• Changes in the levels of LDL after 36 training sessions (mg/dl)

  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.

  After 3 month of training (36 training sessions)

• Changes in the levels of HDL after 36 training sessions (mg/dl)

  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.

  After 3 month of training (36 training sessions)

• Changes in the levels of Glucose after 36 training sessions (mg/dl)

  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.

  After 3 month of training (36 training sessions)

Secondary Outcomes (4)

• Changes in the Estimated maximum oxygen volume after 36 training sessions (ml/kg/min)

  After 3 month of training (36 training sessions)

• Changes in the unit of measurement of the metabolic index (METs) after 36 training sessions (ml/kg/min)

  After 3 month of training (36 training sessions)

• Changes in the Distance traveled after 36 training sessions (m)

  After 3 month of training (36 training sessions)

• Changes in the Dyspnoea after 36 training sessions

  After 3 month of training (36 training sessions)

Study Arms (3)

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).

Other: Group continuous training at moderate intensity

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%).

Other: Group high Intensity Interval Training

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.

Other: Group control

Interventions

Group continuous training at moderate intensity 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 continuous training at moderate intensity

Group high Intensity Interval Training 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 high Intensity Interval Training

Group control 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.

Group control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tolteca: lead

MeSH Terms

Conditions

Neoplasms; Fatigue; Sarcopenia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, specialist in cardiopulmonary rehabilitation, magister in health sciences, university professor.

Model Details: 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).

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: November 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share