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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:
Participants will:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Poli, Dr. | University of Bari Aldo Moro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Società Ginnastica Angiulli | Bari | 70124 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2025 |
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|
| 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). |
|
| 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 |
| 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 |
| Jan 28, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2025 | Jan 28, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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