Comparing Multicomponent and Isometric Multicomponent Training: Impact on Fitness, Health, and Life Quality in Heart Patients

University of Bari Aldo Moro

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Other: Multicomponent Training Protocol; Other: Isometric Multicomponent Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06819098

0324885

Details and patient eligibility

About

The goal of this clinical trial is to evaluate if a multicomponent training program (MCT), including aerobic and resistance exercises, or an isometric multicomponent training program (IMCT) can improve physiological, physical fitness, mental well-being, and quality of life in adults and elderly with a history of cardiovascular diseases (CVDs) currently stabilized. The main questions it aims to answer are:

Does MCT or IMCT improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (WLCG)? Does IMCT provide superior physiological improvements compared to MCT?

Researchers will compare:

• MCT (a combination of aerobic, mobility, and resistance training exercises)
• IMCT (a combination of aerobic, mobility, and isometric exercises) to see if these interventions improve health and quality of life outcomes compared to WLCG (participants not engaging in structured physical activity during the study), and if there will be significant physiological differences between MCT and IMCT .

Participants will:

• Complete assessments of anthropometric, hemodynamic, physical fitness, and psychological parameters at baseline (T0) and after 24 weeks (T1).
• Be randomly assigned to one of three groups (MCT, IMCT, or WLCG).
• Engage in a 24-week structured training program (MCT or IMCT) supervised by exercise professionals, including:
• Warm-up sessions (10 minutes, low-intensity walking).
• Main sessions (40 minutes): aerobic, mobility, resistance (MCT), or isometric (IMCT) exercises.
• Cool-down sessions (10 minutes): breathing and stretching exercises.

This study will provide insights into the efficacy of tailored physical activity interventions for individuals with a history of cardiovascular conditions.

Enrollment: 36 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women/Men
• Aged 45-80 years
• Absence of severe medical conditions (unstable coronary artery disease, decompensated heart failure, severe pulmonary hypertension) or acute onset conditions that would prevent safe participation in physical activity, according to guidelines from the American College of Sports Medicine (ACSM), American Heart Association (AHA), and European Society of Cardiology (ESC).
• History of cardiovascular dysfunctions currently stabilized.
• Sedentary lifestyle (individuals who have not followed WHO guidelines for aerobic and resistance exercise in the past 3 months).

Exclusion criteria

• Smokers
• Expected absence of more than one week during the intervention period
• Lack of a medical certificate for non-competitive sports fitness
• Severe musculoskeletal or joint disorders with significant mobility limitations
• Presence of joint pain, dizziness, chest pain, or angina during physical activity
• High blood pressure: PBP ≥ 160/100 (untreated)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

Multicomponent Training (MCT)

Experimental group

Description:

subjects assigned to the MCT group will perform a training protocol defined multicomponent training, which includes aerobic, resistance and flexibility components.

Treatment:

Other: Multicomponent Training Protocol

Isometric Multicomponent Training (IMCT)

Experimental group

Description:

subjects assigned to the IMCT group will perform the same training protocol of MCT group but resistance training componet will be replaced with isometric one.

Treatment:

Other: Isometric Multicomponent Training

Waiting List Control Group (WLCG)

No Intervention group

Description:

Subjects assigned to the WLCG group will not engage in any structured physical activity throughout the intervention period, continuing with their usual lifestyle, and will be placed on a waiting list, ensuring their participation in adapted physical activity at the end of the 24-week intervention.