Clinical trial NCT06819098: Comparing Multicomponent and Isometric Multicomponent Training: Impact on Fitness, Health, and Life Quality in Heart Patients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Blood pressure
Physical activity
Resistance training
Isometric training
Health status
Quality of life
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Heart Rate
timeFrame: 24-weeks
measure: Change in Resting Diastolic Blood pressure
timeFrame: 24-weeks
measure: Change in Resting Systolic Blood pressure
timeFrame: 24-weeks
measure: Change in lower body strength
timeFrame: 24-weeks
measure: Change in functional mobility
timeFrame: 24-weeks
measure: Change in Handrigp Strength
timeFrame: 24-weeks
measure: Change in aerobic capacity
timeFrame: 24-weeks
measure: Change in psychological parameters.
timeFrame: 24-weeks
Secondary outcomes:
measure: Evaluation of motivation
timeFrame: 24-weeks
measure: Evaluation of enjoyment
timeFrame: 24-weeks
measure: Evaluation of adherence to training protocols
timeFrame: 24-weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Società Ginnastica Angiulli
Study officials:
affiliation: University of Bari Aldo Moro
name: Luca Poli, Dr.
role: PRINCIPAL_INVESTIGATOR
References: