Effectiveness of Combined Aerobic and Strength Training in Acute and Chronic Adaptations in Patients With Heart Failure

NCT03320655 | Completed DMC

• 1 other identifier: 28/2017
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic heart failure (CHF) underwent to a hospital-based cardiac rehabilitation (CR) program in the Lisbon district Hospitals will be recruited. The participants will be randomized into one of the following exercise groups: A) combined exercise training with more aerobic training and less strength training (CAT); B) combined exercise training with more strength training and less aerobic training (CST). The investigators will test two proportions in combined training, CAT and CST. There hasn't been any data on the so called combined regimes, which include both aerobic exercise with HIIT and ST and the investigators will evaluate the effects of acute and chronic response. The research project will contribute to a better understanding in several aspects that are unexplained by scientific research.

Conditions

Chronic Heart Failure; Fragility

Keywords

Chronic Heart Failure; Fragility

Outcome Measures

Primary Outcomes (6)

• Change from Baseline Echocardiogram at 3 months

  A resting transthoracic echocardiogram will be performed with MyLab Alpha, ESAOTE, Italy. The exam will be performed by the echocardiography laboratory cardiologists, who will be blinded to experimental protocol and group randomization, with the usual measurements of systolic and diastolic function, particularly the calculation of LVEF by Simpson's formula, telediastolic and telessystolic volumes and diameters, doppler analysis of the transmitral flow, tissue doppler and quantification of mitral valve regurgitation.

  At baseline and 3 months after Cardiac Rehabilitation

• Change from Baseline Cardiopulmonary Exercise Test at 3 months

  This test will be performed with the subjects in a non-fasting condition and under the regular medication. A symptom-limited ramp incremental CPET, will be performed on a cycle ergometer with breath-by-breath gas exchange measurements. Each patient will be encouraged to exercise to exhaustion. Patients will continue seated on the cycle ergometer as soon as they stop, while recovery measurements are taken. Blood pressure will be continuous recorded Peak oxygen capacity will be considered the highest attained VO2 during the final 30 sec of exercise and ventilator AT will be estimate by the V-slope method. The recovery period will continue until 6 min after peak effort. All patients should achieve a respiratory exchange ratio of \>1.1. We will study, the HR max and recovery at 1st and 3rd min, the VO2 peak, respiratory exrespiratory exchange ratios, respiratory quotient, ventilatory anaerobic threshold, the ventilatory equivalent for O2 and CO2 .

  At baseline and 3 months after Cardiac Rehabilitation

• Change from Baseline Arterial Stiffness at 3 months

  Arterial stiffness will be measured by pulse wave velocity(PWV) obtained by applanation tonometry will be measured during a 15 and 30min rest.A single operator locates the arteries on the right side of the body and mark the point for capturing the corresponding pressure curves with 2 specific pressure sensitive transducers. The distance between the carotid and femoral, radial and distal posterial tibial arteries will be measured directly and entered into the Complior Analyse software. Right brachial blood pressure will be measured and entered in software, and then signal acquisition is launched. When the operator observes 10 carotid pulse wave forms of at least90% quality showed on the software, pressure curves will be recorded. Values obtained from the carotid to femoral artery, carotid to radial artery and carotid to distal posterial tibial artery are taken as indices of central/aortic, upper and lower limb arterial stiffness, respectively.

  At baseline and 3 months after Cardiac Rehabilitation

• Change from Baseline Intima-Media Thickness at 3 months

  Carotid intima media thickness(cIMT) will be defined as the distance between the leading edge of the lumen-intima interface to the leading edge of the media-adventitia interface of the far wall of the right carotid artery using an ultrasound scanner. cIMT is automatically measured, and distension curves are acquired within a segment of the carotid artery about 1cm before the flow divider, where the operator places the region of interest. To evaluate the acute effects of ExT, at the pre-exercise measurement at 5,15and 30min rest, blood pressure(BP) was measured twice on the right upper arm in a dorsal decubitus position. The final measured value was used for the analysis. Immediately after measuring BP. Post-exercise measurement was carried out with the same methods. From this test, the investigators will study the diameter and distensibility of the artery,cIMT, PWV, brachial blood pressure, and the alpha and beta index.

  At baseline and 3 months after Cardiac Rehabilitation

• Change from rest Arterial Stiffness and post effort

  Arterial stiffness will be measured by pulse wave velocity(PWV) obtained by applanation tonometry will be measured during a 15 and 30min rest.A single operator locates the arteries on the right side of the body and mark the point for capturing the corresponding pressure curves with 2 specific pressure sensitive transducers. The distance between the carotid and femoral, radial and distal posterial tibial arteries will be measured directly and entered into the Complior Analyse software. Right brachial blood pressure will be measured and entered in software, and then signal acquisition is launched. When the operator observes 10 carotid pulse wave forms of at least90% quality showed on the software, pressure curves will be recorded. Values obtained from the carotid to femoral artery, carotid to radial artery and carotid to distal posterial tibial artery are taken as indices of central/aortic, upper and lower limb arterial stiffness, respectively.

  Assessment before session in 15 minutes rest and after session at 5, 15 and 30 minutes pos effort

• Change from rest Intima-Media Thickness and post effort

  Carotid intima media thickness(cIMT) will be defined as the distance between the leading edge of the lumen-intima interface to the leading edge of the media-adventitia interface of the far wall of the right carotid artery using an ultrasound scanner. cIMT is automatically measured, and distension curves are acquired within a segment of the carotid artery about 1cm before the flow divider, where the operator places the region of interest. To evaluate the acute effects of ExT, at the pre-exercise measurement at 5,15and 30min rest, blood pressure(BP) was measured twice on the right upper arm in a dorsal decubitus position. The final measured value was used for the analysis. Immediately after measuring BP. Post-exercise measurement was carried out with the same methods. From this test, the investigators will study the diameter and distensibility of the artery,cIMT, PWV, brachial blood pressure, and the alpha and beta index.

  Assessment before session in 15 minutes rest and after session at 5, 15 and 30 minutes pos effort

Secondary Outcomes (6)

• Change from Baseline Body Composition- Dual Energy Radiographic at 3 months ABSORPTIOMETRY

  At baseline and 3 months after Cardiac Rehabilitation

• Change from Baseline Objective Measured Physical Activity at 3 months

  At baseline and 3 months after Cardiac Rehabilitation

• Change from Baseline Funtional Physical Fitness Tests at 3 months

  At baseline and 3 months after Cardiac Rehabilitation

• Change from Baseline Isometric Strength at 3 months

  At baseline and 3 months after Cardiac Rehabilitation

• Change from Baseline Maximal Strength at 3 months

  At baseline and 3 months after Cardiac Rehabilitation

Study Arms (2)

Combined Aerobic Training

ACTIVE COMPARATOR

The subjects will perform in ST part, always only 1 set in the 6 machines early mentioned. During the first and second week they will do 12 repetitions at 40% - 50% of 1 RM. In the third and fourth week progress to 10 repetitions at 60%-70% of 1 RM, and in the second and third month, 8 repetitions at 70%-80% of 1 RM. In the AT part the HIIT protocol is based on a ratio 2 min : 1 min. Consisted of 10 interval training periods (2 min of high intensity at 85% - 90% of heart rate reserve (HRreser) and 9 pauses (1 min in passive pause) between interval training periods. During the first week of training will start with a continuous training, in the second week will start with 5 intervals of HIIT, and in the second and third months they are doing the 10 stages of HIIT.

Other: Combined Strength Training

Combined Strength Training

EXPERIMENTAL

During the first and second week subjects will perform 1 sets with 12 repetitions at 40% - 50% of 1 RM in the 6 machines mentioned before. In the third and fourth week strength exercises progress to 2 sets of 10 repetitions, at 60%-70% of 1 RM, and in the second and third month consists of 3 sets at 8 repetitions, at 70%-80% of 1 RM. In the AT part the HIIT protocol is based on a ratio 2 min : 1 min. Consisted of of 5 interval training periods (2 min of high intensity: 85% - 90% of HRreser) and 4 pauses (1 min in passive pause) between interval training periods. During the first week of training will start with a continuous training, in the second week will start with 3 intervals of HIIT, and after the third/fourth week they are doing the 5 stages of HIIT.

Other: Combined Aerobic Training

Interventions

Combined Aerobic Training OTHER

The subjects will perform in ST part, always only 1 set in the 6 machines early mentioned. During the first and second week they will do 12 repetitions at 40% - 50% of 1 RM. In the third and fourth week progress to 10 repetitions at 60%-70% of 1 RM, and in the second and third month, 8 repetitions at 70%-80% of 1 RM. In the AT part the HIIT protocol is based on a ratio 2 min : 1 min. Consisted of 10 interval training periods (2 min of high intensity at 85% - 90% of heart rate reserve (HRreser) and 9 pauses (1 min in passive pause) between interval training periods. During the first week of training will start with a continuous training, in the second week will start with 5 intervals of HIIT, and in the second and third months they are doing the 10 stages of HIIT.

Combined Strength Training

Combined Strength Training OTHER

During the first and second week subjects will perform 1 sets with 12 repetitions at 40% - 50% of 1 RM in the 6 machines mentioned before. In the third and fourth week strength exercises progress to 2 sets of 10 repetitions, at 60%-70% of 1 RM, and in the second and third month consists of 3 sets at 8 repetitions, at 70%-80% of 1 RM. . In the AT part the HIIT protocol is based on a ratio 2 min : 1 min. Consisted of of 5 interval training periods (2 min of high intensity: 85% - 90% of HRreser) and 4 pauses (1 min in passive pause) between interval training periods. During the first week of training will start with a continuous training, in the second week will start with 3 intervals of HIIT, and after the third/fourth week they are doing the 5 stages of HIIT.

Combined Aerobic Training

Eligibility Criteria

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

You may qualify if:

• CHF patients; receiving optimal medical therapy for CHF (including an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker and a beta-blocker unless a contraindication is evident) with a stable condition for more than 1 month (no hospitalization for heart failure (HF), no change in medication, and no change in New York Heart Association (NYHA) functional class.

You may not qualify if:

• If they are younger than 18 years or are unable to sign informed consent; unstable angina pectoris; and orthopedic or neurological limitations to exercise.

Sponsors & Collaborators

• University of Lisbon: lead

Study Sites (1)

Faculty of Human Kinetics

Lisbon, 1495-687, Portugal

Location

Related Publications (29)

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Study Officials

• Maria Helena Santa-Clara Pombo Rodrigues, PhD

  University of Lisbon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Teacher

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 25, 2017
• Study Start: October 9, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 30, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

PT (1)