Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of the Aerobic Exercise Versus Exercise of Force on the Hemodynamic, Lipidic, Anthropometric and Psychological Variables of Patients With Cardiac Failure

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: NCT03913780
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Javier Eliecer Pereira Rodriguez, University Tolteca

Brief Summary:

Introduction and objectives: At the global level, cardiovascular diseases are the leading cause of mortality. Currently, rehabilitation programs are shown as an effective treatment to mitigate the effects of heart failure. The main objective is to compare the effects of aerobic exercise and strength in patients with heart failure after a cardiovascular rehabilitation program.

Methods and materials: Randomized controlled trial over a period of 3 years with patients with heart failure distributed in 3 groups (Aerobic exercise, aerobic exercise plus upper limb -MMSS- training, aerobic exercise plus training of lower limb -MMII-). Blood samples were taken to determine blood glucose levels and lipid profile. In addition, tests for aerobic capacity, maximum heart rate, anthropometry, depression, anxiety, clinical and hemodynamic parameters. The tests were performed before and after 24 training sessions, 60 min, 3 times a week for two months.


Condition or disease Intervention/treatment Phase
Heart Failure Cardiac Failure Other: Aerobic exercise more force Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 920 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 920 high-risk patients in cardiac rehabilitation, who after the exclusion criteria, 764 individuals were organized into 3 groups. This research for the group number 1 was retrospective with medical record and for groups 2 and 3 it was a randomized controlled trial with a basic probabilistic sampling by means of a table of random numbers, whose order was randomized through the Microsoft Excel 16.0 program, being the group experimental 1 at the end with 253 participants (aerobic exercise without strength training), 256 participants in experimental group 2 (aerobic exercise + strength training in the upper extremities) and control group with 255 (aerobic exercise + strength training for the lower extremities).
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : April 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1 (Medical record)
For group 1, participants do not have intervention as groups 2 and 3. This group consists of reviewing the medical history of the year 2000 to determine the variables of the study and then compare them with groups 2 and 3. This group of participants they were from the year 2000 and whose information will be strictly taken from their medical history was based on initial training with warm-up and walking, after that, aerobic training was performed from 50 to 70% of their maximum heart rate and they finished their session training with breathing exercises, coordination, balance and walking.
Other: Aerobic exercise more force
The work force for aerobic exercise is 50 to 70% of your maximum heart rate (HRM) achieved in the stress test according to the Naughton protocol. For strength, between 30% to 50% of 1 RM was determined, prolonging a percentage of heart rate that did not surpass 70% of the FCM nor the subjective uptake of physical effort to more than 6 on the modified Borg scale.
Other Name: Physical training

Experimental: Group 2: Aerobic exercise + Strength training in MMSS

For group 2, participants begin their training with warm-up and walking, after that, performed aerobic exercise in endless band and elliptical bike more strength exercises for upper limbs with dumbbells, multi-strength equipment and Theraband.

The prescription of aerobic exercise was given from 50 to 70% of your maximum heart rate and for strength, between 30% to 50% of 1 RM was determined, prolonging a percentage of heart rate that did not surpass 70% of the FCM nor the subjective uptake of physical effort to more than 6 on the modified Borg scale.

Other: Aerobic exercise more force
The work force for aerobic exercise is 50 to 70% of your maximum heart rate (HRM) achieved in the stress test according to the Naughton protocol. For strength, between 30% to 50% of 1 RM was determined, prolonging a percentage of heart rate that did not surpass 70% of the FCM nor the subjective uptake of physical effort to more than 6 on the modified Borg scale.
Other Name: Physical training

Experimental: Group 3: Aerobic exercise + Strength training in MMII

For group 3, participants begin their training with warm-up and walking, after that, performed aerobic exercise in endless band and elliptical bike more the strength training for lower limbs with theraband, multi-strength equipment and exercises for activation of the sole-twin pump.

The prescription of aerobic exercise was given from 50 to 70% of your maximum heart rate and for strength, between 30% to 50% of 1 RM was determined, prolonging a percentage of heart rate that did not surpass 70% of the FCM nor the subjective uptake of physical effort to more than 6 on the modified Borg scale.

Other: Aerobic exercise more force
The work force for aerobic exercise is 50 to 70% of your maximum heart rate (HRM) achieved in the stress test according to the Naughton protocol. For strength, between 30% to 50% of 1 RM was determined, prolonging a percentage of heart rate that did not surpass 70% of the FCM nor the subjective uptake of physical effort to more than 6 on the modified Borg scale.
Other Name: Physical training




Primary Outcome Measures :
  1. Changes in ejection fraction after 24 training sessions (%) [ Time Frame: After 2 month of training (24 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 in the Body weight after 24 training sessions (Kg) [ Time Frame: After 2 month of training (24 training sessions) ]
    How much body weight (kg) pre and post intervention

  3. Changes in the Body Mass Index after 24 training sessions (%) [ Time Frame: After 2 month of training (24 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.

  4. Changes in the Abdominal circumference after 24 training sessions (cm) [ Time Frame: After 2 month of training (24 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 91cm for men and 89cm for women.

  5. Changes in the Fat percentage after 24 training sessions (%) [ Time Frame: After 2 month of training (24 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.

  6. Changes in the Muscle percentage after 24 training sessions (%) [ Time Frame: After 2 month of training (24 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.

  7. Changes in the levels of Depression and Anxiety after 24 training sessions [ Time Frame: After 2 month of training (24 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.

  8. Changes in the levels of Total cholesterol after 24 training sessions (mg/dl) [ Time Frame: After 2 month of training (24 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.

  9. Changes in the levels of Triglycerides after 24 training sessions (mg/dl) [ Time Frame: After 2 month of training (24 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.

  10. Changes in the levels of LDL after 24 training sessions (mg/dl) [ Time Frame: After 2 month of training (24 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.

  11. Changes in the levels of HDL after 24 training sessions (mg/dl) [ Time Frame: After 2 month of training (24 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.

  12. Changes in the levels of Glucose after 24 training sessions (mg/dl) [ Time Frame: After 2 month of training (24 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.

  13. Changes in the Dyspnoea after 24 training sessions [ Time Frame: After 2 month of training (24 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.

  14. Changes in the Fatigue after 24 training sessions [ Time Frame: After 2 month of training (24 training sessions) ]
    It is a feeling of lack of energy, exhaustion or fatigue. The fatigue 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 fatigue.

  15. Changes of the maximum heart rate in a effort test after 24 training sessions [ Time Frame: After 2 month of training (24 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.


Secondary Outcome Measures :
  1. Changes in the Estimated maximum oxygen volume after 24 training sessions (ml/kg/min) [ Time Frame: After 2 month of training (24 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 24 training sessions (ml/kg/min) [ Time Frame: After 2 month of training (24 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 24 training sessions (m) [ Time Frame: After 2 month of training (24 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants in the cardiac rehabilitation program.
  • To sign an informed consent endorsed by the ethics and research committee of the institution.
  • Participants with heart failure 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 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 item for cardiac rehabilitation were not admitted in the study.
  • Participants to show hemodynamic instability without improving during any test or during the intervention process.

Layout table for additonal information
Responsible Party: Javier Eliecer Pereira Rodriguez, Physiotherapist, specialist in cardiopulmonary rehabilitation, magister in health sciences, university professor., University Tolteca
ClinicalTrials.gov Identifier: NCT03913780     History of Changes
Other Study ID Numbers: UTolteca
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 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.

Layout table for additional information
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:
Exercise
Force
Cardiac Rehabilitation
Rehabilitation
Heart Failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases