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
Phase: NA
Conditions: Cardiovascular Diseases
Sponsor: University of Bari Aldo Moro

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PROJECT TITLE 
Adapted Multicomponent Training (Adapted Physical and Sports Activity - AFA) for promoting 
well-being in individuals already affected by cardiovascular diseases in currently stable or chronic 
conditions. 
 
LABORATORY/DEPARTMENT 
Laboratory of Exercise Science and Sport, Degree Program in Sports Science and Techniques, 
Department of Translational Biomedicine and Neurosciences (DiBraiN), University of Bari – Aldo 
Moro 
 
EXPERIMENTAL DESIGN 
Interventional 
 
EXPECTED START AND END DATE OF THE PROJECT 
January 2025 – June 2025 
 
FUNDS USED FOR THE PROJECT 
No 
 
DATE OF THE DOCUMENT  
28/01/2025 
 
 
 
 
 
 
 
 
 
 
 
 
 

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SCIENTIFIC RATIONALE 
Cardiovascular diseases (CVDs) remain a significant concern for global health, representing a 
considerable burden in terms of morbidity and mortality. The prevalence of CVDs is continuously 
increasing, and their impact on physical health and quality of life (QoL) is profound (Saglietto et al., 
2021; Townsend et al., 2022). Risk factors such as obesity, hypertension, hypercholesterolemia, 
aging, and insufficient physical activity contribute to CVDs (Kraus et al., 2019; Tian & Meng, 2019). 
Physical activity (PA) has emerged as a crucial therapeutic strategy in the management and 
prevention of CVDs, helping to improve cardiovascular function, fitness, and overall QoL (Franklin 
et al., 2022). Physical training, especially aerobic training (AT) and resistance training (RT), has 
drawn attention as a non-pharmacological approach to managing CVDs. RT has shown potential 
benefits in improving muscle function, skeletal muscle mass, insulin sensitivity, blood pressure 
regulation, and endothelial function (Oliveira et al., 2018; Trevizani et al., 2018). Recently, isometric 
exercises, once considered to be contraindicated for treating cardiovascular diseases, have been 
shown to be the most effective in managing conditions like hypertension (Edwards et al., 2024). The 
complexity of CVDs requires a holistic approach to exercise prescription. Multicomponent training 
(MCT) protocols aim to address various aspects of fitness, targeting not only cardiovascular 
endurance but also muscle strength, mobility, and balance (Bouaziz et al., 2016). These components 
can collectively contribute to improved functional capacity and enhanced QoL (Bouaziz et al., 2016). 
The impact of integrating multiple exercise modalities into an MCT for CVDs remains 
underexplored. It is not yet entirely clear which protocol may be the most efficient for improving 
physiological and psychological parameters in individuals with a history of cardiovascular problems 
that are currently stable. 
 
AIMS AND HYPOTHESES OF THE PROJECT 
 
Primary outcome: 
The purpose of this study is to evaluate the effectiveness of MCT on physiological parameters, 
physical fitness, mental well-being, and quality of life in individuals with a history of cardiovascular 
problems that are currently stable, compared to an integrated multicomponent training protocol with 
isometric exercises (IMCT) and a waitlist control group (WLCG). 
 
Secondary outcome: 

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Assess the enjoyment/motivation in performing the different training protocols, as well as adherence 
through analysis of dropout rates and the number of completed sessions. 
 
Hypothesis: 
We hypothesize that both groups will report improvements in physiological parameters, physical 
fitness, mental well-being, and overall quality of life compared to the WLCG. Additionally, the IMCT 
group will show superior improvements in physiological parameters compared to the MCT group. 
 
 
CHARACTERISTICS OF PARTICIPANTS 
 
The study aims to recruit at least 30 individuals with a history of cardiovascular problems, 
currently stable, aged between 45–80 years. 
 
Inclusion Criteria 
 
- 
    Women/Men 
- 
    45–80 years old 
- 
    Absence of severe medical conditions (unstable coronary artery disease, decompensated 
heart failure, severe pulmonary hypertension) or acute conditions that would prevent safe 
participation in physical activity according to the guidelines of the American College of 
Sports Medicine (ACSM), American Heart Association (AHA), and the European Society of 
Cardiology (ESC) (Billinger et al., 2014; Gary Liguori & ACSM, 2021; Pelliccia et al., 2021; 
Williams et al., 2007) 
- 
    History of cardiovascular dysfunctions currently stabilized 
- 
    Sedentary lifestyle (individuals not having followed WHO guidelines for aerobic and 
resistance exercise in the last 3 months) 
 
Exclusion Criteria 
 
- 
    Smokers 
- 
    Expected absence for more than one week during the intervention period 
- 
    Absence of a medical certificate of suitability for non-competitive sports 
- 
    Severe musculoskeletal or joint disorders with significant mobility limitations 

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- 
    Presence of joint pain, dizziness, chest pain, or angina during physical activity 
- 
    High blood pressure: PBP ≥ 160/100 (untreated)) 
 
 
SAMPLE SIZE 
 
A priori power analysis (Kang, 2021) with a Type I error of 0.05 and Type II error rate of 0.05 (95% 
statistical power) calculated that 10 participants per group would be sufficient to observe moderate 
interaction effects between “Time x Group.”  
 
RECRUITMENT METHOD 
 
Participants will be recruited through the "Amici di Cuore" association located at Piazza G. Cesare 
No. 11, c/o Istituto Morgagni Policlinico, 70124 Bari, and will be randomly assigned to one of three 
groups: 
 
- 
MCT 
- 
IMCT 
- 
WLCG 
 
 
data collection 
Before the intervention, all participants, with prior approval from their primary care physician, will 
sign an informed consent form. All participants will undergo physiological evaluations and functional 
tests before (T0) and at the end of the intervention (T1). Data will be collected anonymously, 
assigning each participant a random identification number. 
 
Measurements:  
 
Anthropometric Parameters:  
- 
Height 
- 
Weight 
- 
BMI 
 

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Hemodynamic Parameters:  
- 
Resting Heart rate (RHR) 
- 
Peripheral Systolic Blood Pressure (P-SBP) 
- 
Peripheral Dyastolic Blood Pressure (P-DBP) 
 
Physical Parameters: 
- 
Timed Up and GO (TUG)  
- 
30 Seconds Chair Stand Test (30”CST)  
- 
2 Minutes Step Test (TMST)  
- 
Handgrip Strength Test (HGS) 
 
Psychological Parameters: 
- 
SF-36 
- 
BREQ-3 
 
Experimental Design 
After initial evaluations, participants will be randomly assigned to one of the three groups. All 
protocols will last 24 weeks and take place at the Angiulli Artistic Gymnastics Society (Bari). 
Sessions will be conducted in small groups. These groups will be closely supervised by exercise 
professionals, specialists in adapted physical activity (AFA), to ensure participant safety, maintain 
proper intensity, and correct execution technique. To monitor and regulate training intensity (internal 
load) during sessions, the Borg Perceived Exertion Scale (RPE) (6-20) will be used at the end of each 
exercise set to regulate the load to Borg = 13-15 points (Gary Liguori & ACSM, 2021). Participants 
will be familiarized with the scale beforehand. 
Participants in the WLCG will not perform any structured physical activity during the entire 
intervention period, maintaining their usual lifestyle and placed on a waiting list to receive adapted 
physical activity after the 24-week intervention period.  
 
Multi-component Training: 
Each training session will include an initial muscle activation phase lasting 10 minutes (low-intensity 
walking, Borg = 10-11) to increase heart rate, improve muscle blood flow, and prepare the main joints 
for the subsequent work phase. This will be followed by a main 40-minute exercise period (aerobic 
exercise, mobility exercises, and resistance training) and a 10-minute cool-down period (breathing 
exercises and stretching). 

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The cardiorespiratory training will consist of progressive aerobic exercises: controlled and rhythmic 
jumping jacks, step-ups on a stable platform (such as a low step or a stable surface), alternating knee 
lifts, rapid lateral steps, or lateral leg raises. Finally, 3 minutes of low-intensity walking will facilitate 
recovery for the next training phase. 
The mobility training will consist of specific exercises (thoracic extensions, cat-cow, overhead 
stretching with a stick, and active internal hip rotations) targeting the main joints. These will be 
performed to the maximum (1 to 3 sets) but avoiding pain. The duration will gradually increase from 
30 to 60 seconds per repetition, repeating from one to three times. Rest intervals of 30 to 60 seconds 
will be provided between sets and exercises. 
The resistance training will consist of exercises targeting different muscle groups (8 exercises): 
quadriceps (leg extension with ankle weights/half squat with a chair), biceps (unilateral dumbbell 
curl), shoulders (dumbbell shoulder press), triceps (dumbbell French press), chest (dumbbell chest 
press/dumbbell flyes), and back (dumbbell rows). The resistance training program will follow the 
principle of gradual progressive load. Initially, participants will perform one set of 10-15 repetitions, 
which will increase to three sets of 10-15 repetitions during the intervention. Load adjustments will 
be made to ensure that the perceived effort (RPE) remains between 13 and 15 on the Borg Scale (6-
20). During the protocol, participants will be given rest intervals of 60 to 120 seconds between sets 
and exercises. To prevent early muscle fatigue, exercises will be performed using an alternating 
training method based on muscle group division (upper body exercises will be performed in the first 
session and lower body exercises in the second). 
The cool-down period will consist of breathing exercises and stretching. Stretching will be performed 
by seeking the maximum stretch on all the main muscle groups (1 to 3 sets per muscle group) while 
avoiding joint pain. The duration will gradually increase from 10 to 30 seconds per stretch, repeating 
from one to three times for a total of 60 seconds per exercise. 
 
Isometric Multi-component Training: 
Each training session will include an initial phase of muscle activation lasting 10 minutes (low-
intensity walking, Borg = 10-11) to increase heart rate, improve blood flow to muscles, and prepare 
the main joints for the subsequent work phase. This will be followed by a main 40-minute exercise 
period (aerobic exercise, mobility exercises, and isometric training) and a 10-minute cool-down 
period (breathing exercises and stretching). The cardiorespiratory training will consist of progressive 
aerobic exercises: controlled and rhythmic jumping jacks, step-ups on a stable platform (such as a 
low step or a stable surface), alternating knee lifts, quick lateral steps, or lateral leg raises. Finally, 3 
minutes of low-intensity walking will facilitate recovery for the subsequent phase of training. 

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The mobility training will consist of specific exercises (thoracic extensions, cat-to-cow movements, 
overhead stretching with a stick, and active internal hip rotation) targeting the main joints, performed 
to the maximum (from 1 to 3 sets), while avoiding pain. The duration will gradually increase from 
30 to 60 seconds per repetition, repeating from one to three times. Recovery intervals of 30 to 60 
seconds will be allowed between sets and exercises. 
The isometric training will focus on exercises targeting different muscle groups (8 exercises): 
quadriceps (isometric leg extension/wall squat), biceps brachii (isometric dumbbell curl), shoulders 
(isometric lateral raises with dumbbells), triceps brachii (isometric French press with dumbbells), 
pectoralis major (isometric dumbbell chest press/dumbbell flyes), latissimus dorsi (isometric 
dumbbell rows). The isometric training program will follow the principle of gradual progressive 
loading. Initially, participants will perform one set of 30 seconds, which will increase to three sets of 
30 seconds over the course of the intervention. Load adjustments will be made to ensure that the 
perceived effort (RPE) stays between 13 and 15 on the Borg Scale (6-20). During the protocol, 
participants will be given recovery intervals of 60 to 120 seconds between sets and exercises. To 
prevent early muscle fatigue, exercises will be performed using an alternating training method based 
on splitting muscle groups (upper body exercises will be performed in the first session and lower 
body exercises in the second). 
The cool-down period will consist of breathing exercises and stretching. Stretching will be performed 
seeking maximum elongation of all major muscle groups (from 1 to 3 sets per muscle group), avoiding 
joint pain. The duration will gradually increase from 10 to 30 seconds per stretch, repeating from one 
to three times for a total of 60 seconds per exercise. 
 
EXPECTED RESULTS AND RELEVANCE 
 
Although the positive effect of physical activity in individuals with a history of cardiovascular 
problems, even in stable conditions, has already been demonstrated, the impact of integrating multiple 
exercise modalities in a MCT or IMCT in the field of cardiovascular diseases (CVDs) remains 
underexplored. It is still not entirely clear what the most efficient protocol might be for improving 
physiological and psychological parameters in individuals with a history of cardiovascular issues, 
currently stabilized. At the end of this exercise program, we expect to observe a general improvement 
in physiological, motor, and psychological parameters, with a greater increase in the IMCT group, 
particularly in relation to physiological parameters. Furthermore, we believe that this new research 
modality could offer a novel approach to proposing a physical activity that is particularly engaging, 
motivating, and designed to improve the quality of life (both physiologically and psychologically). 

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To date, physical exercise remains a crucial factor for promoting psychological and biological 
improvements with profound implications for public health. Indeed, physical activity promises to be 
an important tool to be used alone or in combination with traditional therapies (such as drugs or 
medications), to enhance the effectiveness of prevention and treatment strategies for various chronic 
non-communicable diseases. 
 
 
Critical Situations and Potential Negative Effects 
 
The main risks, though rare, but considered, may include: 
 
• Acute cardiovascular events: participants with a history of pre-existing cardiovascular 
conditions, currently stabilized, may, in rare cases, experience episodes of angina, 
arrhythmias, or increased blood pressure during the training sessions. 
 
• Falls or injuries: the exercises proposed, if performed incorrectly or without supervision, 
could pose a risk of falls or musculoskeletal injuries. 
 
Risk Management Strategies 
 
• Continuous monitoring during sessions: each training group will be supervised by 
professionals specialized in adapted physical activity (APA). The Borg scale will be used to 
monitor the perceived effort during the exercise, keeping it within a moderate range (13-15 
points). 
 
• Emergency procedures: to ensure safety, an emergency plan will be in place. APA operators 
are adequately trained to recognize any symptoms of fatigue or cardiovascular discomfort and 
to intervene promptly if necessary. 
 
 
• Medical support: before starting, participants will provide an exercise clearance evaluation 
signed by the attending doctor/cardiologist, ensuring they are fit to participate. Additionally, 
the proximity (about 3 minutes by car, 1.4 km) to the main local medical facility (Policlinico 
di Bari – University Hospital Consortium, Piazza Giulio Cesare, 11, 70124, Bari) has been 

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considered to allow for quick access to emergency services. 
 
Documentation in the Research Protocol 
 
All preventive measures and management strategies are included in the protocol: 
 
• In the "intervention" section, the structure of the training sessions, the control of exercise 
intensity, and supervision by qualified personnel are provided. 
 
• The management of cardiovascular and musculoskeletal risks is addressed in the 
inclusion/exclusion criteria, which exclude participants with acute or unstable conditions 
to ensure the safety of the study sample. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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