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

NCT ID: NCT06819098

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Multicomponent Training (MCT)

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

Group Type: EXPERIMENTAL

Multicomponent Training Protocol

Intervention Type: OTHER

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Isometric Multicomponent Training (IMCT)

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.

Group Type: EXPERIMENTAL

Isometric Multicomponent Training

Intervention Type: OTHER

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Isometric training: Gradual progression of 8 isometric exercises targeting major muscle groups, such as wall squats, isometric bicep curls, lateral raises, and rows (1-3 sets, 30 seconds per exercise, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Waiting List Control Group (WLCG)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multicomponent Training Protocol

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Intervention Type: OTHER

Isometric Multicomponent Training

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Isometric training: Gradual progression of 8 isometric exercises targeting major muscle groups, such as wall squats, isometric bicep curls, lateral raises, and rows (1-3 sets, 30 seconds per exercise, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bari Aldo Moro

OTHER

Sponsor Role: lead

Responsible Party

Luca Poli

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Poli, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bari Aldo Moro

Locations

Società Ginnastica Angiulli

Bari, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0324885

Identifier Type: -

Identifier Source: org_study_id