Effect of Different Aerobic Exercise Methods in Cardiac Rehabilitation on Endothelial Function in Patients With Ischaemic Heart Disease and Study of the Associated Physiological Mechanisms (ENDO-R)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Endothelial dysfunction is one of the aetiological factors in ischaemic heart disease (IHD). Aerobic exercise is effective in improving endothelial function, as measured by flow-mediated dilation (FMD), in patients with IHD. Within the aerobic exercise methods, there is evidence showing that high-intensity interval training (HIIT) increases FMD to a greater extent than moderate-intensity training (MIT) in these patients. Notably, in a recent review, our research group found that only studies performing long bouts of HIIT (long HIIT: higher than 1 min) found a greater effect on FMD, while no differences were found in those studies using short bouts of HIIT (short HIIT: ≤ 1 min) and MIT. However, no experimental studies comparing the effect of long HIIT, short HIIT, and MIT on endothelial function, as well as other predictors of mortality, such as cardiorespiratory fitness, brain-derived neurotrophic factor (BDNF) levels or parasympathetic branch activity, have been performed. Therefore, the main objective of this project will be to compare the effect of the three aerobic exercise methods on endothelial function, as measured by FMD, in patients with IHD. Complementarily, the effect of aerobic exercise, depending on the exercise method, on different mortality predictors will be compared. For this purpose, a multicentre randomised study will be carried out (2 hospitals in Elche and one in Alicante). Assessors will be blinded to the patients allocation. Participants will be aware about their allocation in the experimental groups due to the nature of the study. A total of 132 men and women with IHD (66 per sex), diagnosed between three and 12 months before the start of the intervention, aged between 45 and 75 years, and without limitations for the practice of exercise training, will be recruited. All patients will train 3 days a week for 12 weeks. Participants will be assessed before the intervention (i.e., pre), at 6 weeks of training (i.e., mid) and after the intervention (i.e., post). Physiological and psychological variables will be registered in the assessment periods. Training intensity will be individually prescribed based on the cardiopulmonary exercise test (CPET). Intensity exercise will be adapted after the first part of the intervention. Analysis of covariance will be used to compare the values of the three groups after the intervention for the continuous variables, including the pre-intervention value as a covariate, while a logistic regression model will be used for the categorical variables.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• Men and women aged between 45 and 75 years.

• Diagnosed with acute myocardial infarction, unstable or stable angina.

• Treated with percutaneous coronary intervention, coronary artery bypass grafting, or conservative treatment.

• Event or intervention within 3 to 12 months prior to participation in the study.

• Fluency in speaking and reading Spanish.

• Residing in Elche or surrounding areas and able to attend evaluations and the exercise programme (not planning to be absent for more than one week during the programme).

• Functional Class I-II according to the New York Heart Association (NYHA) classification.

• No physical limitations for exercise.

• Stable optimal medical treatment.

• Physically inactive, defined as 1) not meeting the World Health Organization recommendations for both aerobic and strength exercise, and 2) not participating in a structured exercise programme at least 3 days per week for more than 3 months. Both conditions must be met for inclusion. Note: Casual walking is not considered grounds for exclusion.

Locations
Other Locations
Spain
Instituto de Investigación Sanitaria y Biomédica de Alicante
RECRUITING
Alicante
Centro de Investigación del deporte
RECRUITING
Elche
Contact Information
Primary
Jose Manuel Sarabia, PhD
jsarabia@umh.es
965222568
Backup
Agustin Manresa Rocamora, PhD
amanresa@umh.es
626542131
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-11
Participants
Target number of participants: 132
Treatments
Experimental: Moderate-intensity training (MIT) group
Continuous exercise training on a cycle ergometer
Experimental: Short high-intensity interval training (HIIT) group
High-intensity interval exercise performed on a cycle ergometer
Experimental: Long high-intensity interval training (HIIT) group
High-intensity interval exercise performed on a cycle ergometer
Sponsors
Leads: Instituto de Investigación Sanitaria y Biomédica de Alicante
Collaborators: Universidad Miguel Hernandez de Elche

This content was sourced from clinicaltrials.gov