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

NCT03913780 | Completed DMC

• 1 other identifier: UTolteca
• Study Type: interventional
• Target: 920
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Cardiac Failure

Keywords

Exercise; Force; Cardiac Rehabilitation; Rehabilitation; Heart Failure

Outcome Measures

Primary Outcomes (15)

• Changes in ejection fraction after 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%

  After 2 month of training (24 training sessions)

• Changes in the Body weight after 24 training sessions (Kg)

  How much body weight (kg) pre and post intervention

  After 2 month of training (24 training sessions)

• Changes in the Body Mass Index after 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.

  After 2 month of training (24 training sessions)

• Changes in the Abdominal circumference after 24 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 91cm for men and 89cm for women.

  After 2 month of training (24 training sessions)

• Changes in the Fat percentage after 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.

  After 2 month of training (24 training sessions)

• Changes in the Muscle percentage after 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.

  After 2 month of training (24 training sessions)

• Changes in the levels of Depression and Anxiety after 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.

  After 2 month of training (24 training sessions)

• Changes in the levels of Total cholesterol after 24 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 2 month of training (24 training sessions)

• Changes in the levels of Triglycerides after 24 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 2 month of training (24 training sessions)

• Changes in the levels of LDL after 24 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 2 month of training (24 training sessions)

• Changes in the levels of HDL after 24 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 2 month of training (24 training sessions)

• Changes in the levels of Glucose after 24 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 2 month of training (24 training sessions)

• Changes in the Dyspnoea after 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.

  After 2 month of training (24 training sessions)

• Changes in the Fatigue after 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.

  After 2 month of training (24 training sessions)

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

  After 2 month of training (24 training sessions)

Secondary Outcomes (3)

• Changes in the Estimated maximum oxygen volume after 24 training sessions (ml/kg/min)

  After 2 month of training (24 training sessions)

• Changes in the unit of measurement of the metabolic index (METs) after 24 training sessions (ml/kg/min)

  After 2 month of training (24 training sessions)

• Changes in the Distance traveled after 24 training sessions (m)

  After 2 month of training (24 training sessions)

Study Arms (3)

Group 1 (Medical record)

ACTIVE COMPARATOR

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

Group 2: Aerobic exercise + Strength training in MMSS

EXPERIMENTAL

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

Group 3: Aerobic exercise + Strength training in MMII

EXPERIMENTAL

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

Interventions

Aerobic exercise more force OTHER

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.

Also known as: Physical training

Group 1 (Medical record); Group 2: Aerobic exercise + Strength training in MMSS; Group 3: Aerobic exercise + Strength training in MMII

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tolteca: lead

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: 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).

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 12, 2019
• Study Start: April 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: January 1, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share