Cardiovascular DiseasesNCT06819098
Comparing Multicomponent and Isometric Multicomponent Training: Impact on Fitness, Health, and Life Quality in Heart Patients
A study testing Multicomponent Training Protocol and Isometric Multicomponent Training in people with Cardiovascular Diseases, run by University of Bari Aldo Moro at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Multicomponent Training Protocol and Isometric Multicomponent Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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?
Read more
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
- Being tested
- Multicomponent Training Protocol, Isometric Multicomponent Training
- Keywords
- Blood pressure, Physical activity, Resistance training, Isometric training, Health status, Quality of life
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Training ProtocolOther
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 TrainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 24-weeks
Change in functional mobility
Timed Up and Go (TUG) Test (measured in seconds)
Measured: 24-weeks
Change in Handrigp Strength
Handgrip Strength (HGS) test: muscle strength measured with manual dynamometers (Kgf)
Measured: 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.
Measured: 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.
Measured: 24-weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 24-weeks
Evaluation of adherence to training protocols
Adherence (%): (Number of prescribed activities/Number of completed activities )×100
Measured: 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start29 Jan 2025
- Primary completion3 Feb 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Poli, University of Bari Aldo Moro
- Investigators
- Luca Poli, Dr., Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819098
- Sponsor's protocol ID
- 0324885
- Status last verified
- Jul 2025
- First submitted
- 22 Jan 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06819098
- Acronym / sponsor ID
- 0324885
- Conditions
- Cardiovascular Diseases
- Keywords
- Blood pressure, Physical activity, Resistance training, Isometric training, Health status, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Training (MCT) | Experimental | Other: Multicomponent Training Protocolsubjects assigned to the MCT group will perform a training protocol defined multicomponent training, which includes aerobic, resistance and flexibility components. |
| Isometric Multicomponent Training (IMCT) | Experimental | Other: Isometric Multicomponent Trainingsubjects assigned to the IMCT group will perform the same training protocol of MCT group but resistance training componet will be replaced with isometric one. |
| 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent Training ProtocolEach 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). | Other | Multicomponent Training (MCT) |
| Isometric Multicomponent TrainingEach 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). | Other | Isometric Multicomponent Training (IMCT) |
Primary outcome
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.
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)
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)
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)
Change in functional mobility
Time frame: 24-weeks
Timed Up and Go (TUG) Test (measured in seconds)
Change in Handrigp Strength
Time frame: 24-weeks
Handgrip Strength (HGS) test: muscle strength measured with manual dynamometers (Kgf)
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.
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.
3 secondary outcomes
Evaluation of motivation
Time frame: 24-weeks
Evaluation of enjoyment
Time frame: 24-weeks
Evaluation of adherence to training protocols
Time frame: 24-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Poli, Dr. principal investigator
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Training Protocol and Isometric Multicomponent Training in people with Cardiovascular Diseases, run by University of Bari Aldo Moro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate (time frame: 24-weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.