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

NCT06819098 | Completed DMC

• 1 other identifier: 0324885
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Blood pressure; Physical activity; Resistance training; Isometric training; Health status; Quality of life

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Evaluation of motivation

  24-weeks

• Evaluation of enjoyment

  24-weeks

• Evaluation of adherence to training protocols

  24-weeks

Study Arms (3)

Multicomponent Training (MCT)

EXPERIMENTAL

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

Isometric Multicomponent Training (IMCT)

EXPERIMENTAL

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

Waiting List Control Group (WLCG)

NO INTERVENTION

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.

Interventions

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).

Multicomponent Training (MCT)

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).

Isometric Multicomponent Training (IMCT)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

Study Sites (1)

Società Ginnastica Angiulli

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Luca Poli, Dr.

  University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 11, 2025
• Study Start: January 29, 2025
• Primary Completion: February 3, 2025
• Study Completion: June 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)