Cardiovascular Diseases
Conditions
Keywords
Blood pressure, Physical activity, Resistance training, Isometric training, Health status, Quality of life
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.
Interventions
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).
OTHERIsometric 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).
Sponsors
University of Bari Aldo Moro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in psychological parameters. | 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. |
| Change in functional mobility | 24-weeks | Timed Up and Go (TUG) Test (measured in seconds) |
| Change in Handrigp Strength | 24-weeks | Handgrip Strength (HGS) test: muscle strength measured with manual dynamometers (Kgf) |
| Change in aerobic capacity | 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 Heart Rate | 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 | 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 | 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 | 24-weeks | 30-s chair stand (30CST) test: Sit-to-stand from a chair during 30 seconds (measured in seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of enjoyment | 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. |
| Evaluation of adherence to training protocols | 24-weeks | Adherence (%): (Number of prescribed activities/Number of completed activities )×100 |
| Evaluation of motivation | 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. |
Countries
Italy
Outcome results
None listed