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

Adapted Multicomponent Training (Adapted Physical and Sports Activity - APA) for Promoting Well-being in Individuals Already Affected by Cardiovascular Diseases in Currently Stable or Chronic Conditions

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Multicomponent Training Protocol; Other: Isometric Multicomponent Training

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Società Ginnastica Angiulli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multicomponent Training (MCT); subjects assigned to the MCT group will perform a training protocol defined multicomponent training, which includes aerobic, resistance and flexibility components.	Other: 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).
Experimental: 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.	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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate	Measured with an average of 3 readings by an automated measurement device (bpm) resting heart rate and peripheral blood pressure (systolic and diastolic blood pressure) will be measured, using the automated oscillometric device.	24-weeks
Change in Resting Diastolic Blood pressure	Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)	24-weeks
Change in Resting Systolic Blood pressure	Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)	24-weeks
Change in lower body strength	30-s chair stand (30CST) test: Sit-to-stand from a chair during 30 seconds (measured in seconds)	24-weeks
Change in functional mobility	Timed Up and Go (TUG) Test (measured in seconds)	24-weeks
Change in Handrigp Strength	Handgrip Strength (HGS) test: muscle strength measured with manual dynamometers (Kgf)	24-weeks
Change in aerobic capacity	2-Minute Step Test (TMST): march in place for 2 minutes, lifting their knees to a height halfway between the iliac crest and the patella.The number of full knee lifts (repetitions) completed in 2 minutes is recorded.	24-weeks
Change in psychological parameters.	SF-36 (Short Form-36) questionnaire: to measure overall health-related quality of life. Scoring range from 0 to 100, where zero indicates the lowest worst health and 100 indicates the best health.	24-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of motivation	BREQ-3 (Behavioral Regulation in Exercise Questionnaire-3): to assess individuals' motivation for exercise based on the Self-Determination Theory (SDT). Each item is rated on a Likert scale (e.g., 0 = "Not true for me" to 4 = "Very true for me"). Scores for each subscale are calculated by averaging the ratings of the items belonging to that subscale. The higher the score in a specific dimension, the stronger that type of motivation.	24-weeks
Evaluation of enjoyment	BREQ-3 (Behavioral Regulation in Exercise Questionnaire-3): Scores for intrinsic motivation subscale (calculated by averaging the ratings of the items belonging to that subscale) could be used as a proxy to assess the enjoyment levels. Each item is rated on a Likert scale (e.g., 0 = "Not true for me" to 4 = "Very true for me").The higher the score the stronger the outcome.	24-weeks
Evaluation of adherence to training protocols	Adherence (%): (Number of prescribed activities/Number of completed activities )×100	24-weeks

Collaborators and Investigators

• Sponsor: University of Bari Aldo Moro
• Investigators: Principal Investigator: Luca Poli, Dr., University of Bari Aldo Moro

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2025
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Physical activity; Blood pressure; Resistance training; Health status; Isometric training
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 0324885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No