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Completed

NCT Number: NCT06819098

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

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Motor Activity

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Società Ginnastica Angiulli

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multicomponent Training Protocol

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

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).

Primary outcomes

  1. Change in Heart Rate

    Time frame: 24-weeks

    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.

  2. Change in Resting Diastolic Blood pressure

    Time frame: 24-weeks

    Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)

  3. Change in Resting Systolic Blood pressure

    Time frame: 24-weeks

    Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)

  4. Change in lower body strength

    Time frame: 24-weeks

    30-s chair stand (30CST) test: Sit-to-stand from a chair during 30 seconds (measured in seconds)

  5. Change in functional mobility

    Time frame: 24-weeks

    Timed Up and Go (TUG) Test (measured in seconds)

  6. Change in Handrigp Strength

    Time frame: 24-weeks

    Handgrip Strength (HGS) test: muscle strength measured with manual dynamometers (Kgf)

  7. Change in aerobic capacity

    Time frame: 24-weeks

    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.

  8. Change in psychological parameters.

    Time frame: 24-weeks

    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.

Secondary outcomes

  1. Evaluation of motivation

    Time frame: 24-weeks

    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.

  2. Evaluation of enjoyment

    Time frame: 24-weeks

    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.

  3. Evaluation of adherence to training protocols

    Time frame: 24-weeks

    Adherence (%): (Number of prescribed activities/Number of completed activities )×100

Sponsors and collaborators

Lead sponsor

University of Bari Aldo Moro

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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