Efficacy of a Personalized Concurrent Exercise Prescription Guide for Controlling Cardiovascular Risk and Enhancing Physical Fitness in Adults From a Cardiovascular Health Program: A Pilot Randomized Controlled Clinical Trial.
Phase: NA
Conditions: Cardiovascular Syndrome, Metabolic
Sponsor: Universidad San Sebastián

 
Faculty of Dentistry and  
Rehabilitation Sciences  
Kinesiology  
Valdivia Campus 
 
 
 
 
 
PROJECT: EFFICACY OF A PERSONALIZED CONCURRENT EXERCISE 
PRESCRIPTION GUIDE ON THE CONTROL OF CARDIOVASCULAR RISK 
FACTORS AND PHYSICAL CAPACITY IN ADULT USERS OF THE 
CARDIOVASCULAR HEALTH PROGRAM AT CESFAM EXTERNO DE 
VALDIVIA. A PILOT RANDOMIZED CONTROLLED TRIAL 
 
 
 
 
 
 
 
 
 
 
 
 
 
23.05.2024 
Valdivia, Chile  

FAPPE Project: EFFICACY OF A PERSONALIZED CONCURRENT EXERCISE 
PRESCRIPTION GUIDE ON THE CONTROL OF CARDIOVASCULAR RISK FACTORS 
AND PHYSICAL CAPACITY IN ADULT USERS OF THE CARDIOVASCULAR HEALTH 
PROGRAM AT CESFAM EXTERNO DE VALDIVIA. A PILOT RANDOMIZED 
CONTROLLED TRIAL 
1. RELEVANCE, PROBLEM STATEMENT, AND SOLUTION 
1.1 RELEVANCE OF THE TOPIC 
Cardiovascular risk factors (CRF) have become a significant global health problem. In 
Chile, the National Health Survey (ENS) 2016-2017 reveals a high prevalence of 
cardiovascular risk factors, highlighting physical inactivity as one of the primary 
triggers. 
The rise in cardiovascular risk factors among the Chilean adult population, both men 
and women, has become a priority issue requiring attention in current public policies. 
Evidence shows that the increase in these factors is directly associated with a higher 
risk of developing cardiovascular diseases, cerebrovascular diseases, and cancer. 
According to the study conducted by Yusuf et al., which included 155,722 subjects from 
21 countries, including Chile, approximately 70% of cardiovascular disease cases and 
deaths in the study were attributed to modifiable risk factors. Notably, individuals with 
low physical activity levels (less than 600 METs minutes per week) had a 20% higher risk 
of developing cardiovascular disease (Hazard Ratio [HR] of 1.20, 95% CI 1.10-1.30) and 
a 39% higher risk of mortality (HR 1.39, 95% CI 1.28-1.50), compared to those with high 
physical activity levels (more than 3000 METs minutes per week). 
Regarding associated costs, in Chile, it is estimated that physical inactivity and its 
health consequences generate an expense of US$ 103 million, with a direct cost of US$ 
69.2 million. The public sector covers 47.4% of these costs, while 31.7% fall on the 
users. The economic burden of physical inactivity represents between 1% and 3% of 
total annual healthcare costs. On the other hand, increasing moderate physical activity 
in sedentary adults can reduce direct medical costs by US$ 300 to US$ 1,053 per 
person per year. 
Physically inactive adults have been observed to have a higher risk of hospitalization 
and surgery, often requiring stays in high-dependency or intensive care units. This stay 
in high-complexity services is associated with an increase in complications and related 
healthcare costs. Conversely, physically active users, if hospitalized or undergoing 
surgery, tend to experience a faster and less costly recovery. 

Currently, there are primary healthcare initiatives for the control of cardiovascular risk 
factors, notably the Cardiovascular Health Program (CHP). This program aims to 
reduce the incidence of cardiovascular events by controlling and managing 
cardiovascular risk factors in primary healthcare. It offers a comprehensive approach, 
including free access to clinical controls, medications, and counseling on healthy 
lifestyles. 
In terms of the relevance and currentness of the topic, it is important to highlight that 
12,966,079 people are registered in one of the 1,890 primary health establishments 
nationwide. Of this population, 2,351,646 are under control in the CHP, with 873,835 
(37%) men and 1,477,811 (63%) women. In the Los Ríos Region, approximately 300,000 
users are registered in primary care establishments, of which 60,102 are under control 
in the CHP, with 22,892 (38%) men and 37,210 (62%) women. According to these data, 
1 in 5 users in Chile and in the Los Ríos region is under control in the CHP, with a higher 
proportion of women. Regarding specific risk factors in the Los Ríos region, there are 
50,291 users with hypertension, 22,669 with type 2 diabetes mellitus, and 35,980 with 
dyslipidemia, of which about 56% (1 in 2) have compensated factors. 
In this context, it is essential to offer therapeutic alternatives for managing these 
cardiovascular risk factors that align with the National Health Strategy for the health 
objectives by 2030. This will reduce associated diseases, lower health costs, and 
improve the quality of life for these users. The national health strategy specifically seeks 
to improve lifestyles, increase the prevalence of physical activity in the population, 
prevent and reduce morbidity, disability, and premature mortality from non-
communicable chronic diseases, reduce health inequalities arising from social and 
economic determinants, and strengthen health research. 
Providing therapeutic strategies such as personalized physical exercise prescription for 
controlling cardiovascular risk factors in primary healthcare would advance towards a 
profile of healthier users with a better quality of life. 
1.2 PROBLEM STATEMENT AND LITERATURE REVIEW 
Over the past century, cardiovascular diseases (CVD) have evolved parallel to the 
epidemiological transition and global economic growth. By the end of the 20th century, 
CVD emerged as the leading cause of death and premature morbidity worldwide. This 
rapid change in the epidemiological profile, shifting from infectious diseases to 
cardiovascular diseases, can be attributed to a health transition marked by unchecked 
urbanization and the adoption of unhealthy lifestyles, resulting in a general decline in 
physical activity. 

Currently, there is a concerning decline in physical activity levels globally, affecting all 
genders and ages. This situation is identified as a modifiable risk factor that can 
precipitate the onset of cardiovascular risk factors (CRF), which could be mitigated by 
increasing overall physical activity. Physical inactivity can trigger muscle insulin 
resistance and alter muscle fibers from oxidative to glycolytic, reducing the use of lipids 
as an energy source. These unmetabolized lipids accumulate in central and peripheral 
adipose tissues and organs as ectopic fat, increasing sympathetic activity and the 
inflammatory response, associated with a higher risk of Hypertension (HTN), Type 2 
Diabetes Mellitus (DM2), and Dyslipidemia (DLP). 
In addition to low physical activity levels, other factors such as abnormal lipids, 
smoking, HTN, DM2, and abdominal obesity constitute the majority of myocardial 
infarction risk globally, across all genders and ages. Approximately 70% of CVD cases 
and deaths in the general population could be attributed to modifiable risk factors. In 
Chile, a high prevalence of physical inactivity (86.7%) has been reported, correlating 
with an increase in CRF prevalence, especially in adults, and with considerable 
associated healthcare costs. 
The 2017 National Health Survey revealed a high prevalence of CRF, including 
overweight, obesity, morbid obesity, and elevated levels of total cholesterol, LDL, and 
triglycerides, as well as HTN and DM2. These factors tend to concentrate from 
adulthood to old age. Regarding acute myocardial infarction (AMI), there is a high 
incidence, especially in older age groups. 
In Chile, it has been identified that low socioeconomic and educational levels are 
social determinants of health that negatively impact, with higher rates of overweight, 
physical inactivity, hypertension, and diabetes observed in lower-income groups. 
These individuals often rely on the public health system. 
Within the public health system, upon detecting these risk factors, individuals can 
access the Cardiovascular Health Program (CHP), which aims to reduce the incidence 
of cardiovascular events by controlling and compensating CRF in primary healthcare. 
This program offers comprehensive risk factor management, including access to 
clinical control, medications, and counseling on healthy lifestyles. Patients are 
classified according to their risk of having a cardiovascular event in the next ten years 
(CVR) as low, moderate, and high, with specific therapeutic goals set for each category. 
Once the goals are defined according to the CVR level, a therapeutic management is 
established consisting of two phases: the compensation phase, aimed at achieving 
therapeutic goals, and the follow-up phase for the compensated patient. In the 
compensation phase, recommendations on healthy lifestyles are made, and 

pharmacological treatment is prescribed according to the risk level. It is expected that 
in the first two to three months from joining the program and receiving medications, the 
patient will compensate their blood pressure, glycemia, glycated hemoglobin, and 
cholesterol levels. In the follow-up stage, controls are suggested according to an 
individualized intervention plan based on cardiovascular risk: high risk every 3 months, 
moderate risk every 6 months, and low risk every 6-12 months, either with a doctor, 
nurse, nutritionist, or senior nursing technician. Among the interventions to promote a 
healthy lifestyle, the promotion of regular moderate-intensity physical activity stands 
out. 
The cardiovascular health program serves a wide range of users with various 
conditions, from individuals with only smoking habits to those who have suffered an 
acute myocardial infarction or have chronic kidney disease. This diversity poses a 
challenge in promoting physical activity for controlling and compensating CRF due to 
the multiple conditions associated with the users. Despite this, the benefits of physical 
exercise in controlling CRF and preventing cardiovascular diseases have been widely 
documented both globally and locally, showing a positive relationship between the 
volume of exercise performed and the benefits observed. In particular, primary 
prevention through the prescription of personalized physical exercise could control and 
compensate CRF, delaying the onset of pathologies such as acute myocardial 
infarction or chronic kidney disease, which is an important factor when evaluating the 
effectiveness of the CHP in compensating users, reducing the demand for care in the 
public health system, and lowering associated healthcare costs. 
Locally, CESFAM Externo de Valdivia has 3764 users enrolled in the CHP, mostly from 
low socioeconomic backgrounds. The CHP promotes physical activity through 
counseling during scheduled check-ups, based on the technical guidelines of the CHP. 
The counseling, conducted by CHP professionals at all check-ups, consists of 
suggesting that users engage in regular moderate-intensity physical activity, without a 
defined dose or a mechanism for evaluating effectiveness, except for achieving the 
therapeutic goals defined upon joining the CHP. Thus, personalized physical exercise is 
not prescribed as an adjunct therapy to the CHP to improve the control and 
compensation of CRF in these users. 
In this context, it has been reported that referral to physical exercise increases the 
likelihood of reaching a recommended level of physical activity to maintain health, with 
a relative risk (RR) of 1.16 [95% CI: 1.03 to 1.30] compared to usual care or simple 
counseling. Other studies have shown an increase of 55 minutes in weekly physical 
activity in users who were referred to an exercise program compared to those who only 
received counseling. 

There are international success stories in this area, such as "Exercise is Medicine" in 
the United States, "Green Prescription Process for Primary Health Care" in New 
Zealand, the exercise prescription of the National Health Board in Sweden, and the 
"Exercise Referral" model in the United Kingdom. All these initiatives focus on improving 
the lifestyles of people with health conditions similar to CHP users, highlighting the 
written prescription of personalized physical exercise as an effective therapeutic 
measure for controlling CRF. 
In Chile, specific exercise programs have been implemented to improve the quality of 
life and physical condition of adults with overnutrition, linked to the CHP. Notable 
examples are the “Cardiosalud” Program of the Ñuble Health Service, lasting seven 
months, and the Personalized Exercise Program of the Castro Municipal Corporation, 
lasting three months. Although results from these programs have not yet been 
published, in the Los Ríos Region, specifically in the commune of Los Lagos, positive 
effects of personalized physical exercise have been observed in CHP users at CESFAM 
Tomas Rojas, including the reduction of blood pressure, improvement of glycemia, lipid 
profile, and physical activity level. 
Among the exercise modalities, concurrent exercise—which combines muscular 
strength and aerobic exercise in the same program—has proven effective in reducing 
CRF and improving physical capacity. The benefits include metabolic and 
morphological changes at the muscular level, such as mitochondrial biogenesis, the 
transformation of muscle fibers from fast to slow, and a more efficient substrate 
metabolism. Additionally, strength exercise promotes the synthesis of contractile 
proteins, increasing maximum strength. These changes favor the recovery of lost 
metabolic flexibility in these users, regulating the glycemic, lipid, and blood pressure 
profiles. 
However, there is an underutilization of personalized physical exercise as a therapeutic 
strategy within the CHP of CESFAM Externo de Valdivia. Therefore, it is crucial to 
enhance CHP actions, integrating personalized physical exercise to promote better 
CRF control. This aligns with the strategic objectives of the National Health Strategy for 
2030, including: 
1. Prevention and reduction of morbidity, disability, and premature mortality from 
non-communicable chronic diseases, especially increasing the control of 
hypertension and diabetes mellitus. 
2. Promotion of healthy habits and lifestyles, such as increasing the prevalence of 
physical activity. 

3. Reduction of health inequalities, providing therapeutic strategies to reduce 
sedentary 
lifestyles, 
hypertension, 
and 
diabetes, 
especially 
in 
low 
socioeconomic CHP users in Valdivia. 
4. Strengthening health research, proposing projects focused on evaluating the 
effectiveness of therapeutic interventions to address primary health issues in 
primary care, such as CRF control in the Cardiovascular Health Program. 
1.3 PROPOSED SOLUTION AND EXPECTED CONTRIBUTION 
The proposed solution involves evaluating the efficacy of a personalized concurrent 
exercise prescription guide, specifically designed to suit the cardiovascular risk and 
physical capacity levels of adult CHP users. This tool aims to provide a protocol of 
aerobic and strength exercises, which when performed systematically, will improve the 
cardiovascular health and physical capacity of users. 
Based on current protocols and models for exercise prescription in CRF control, the 
guide will implement a concurrent exercise protocol. This approach, including aerobic 
exercises (such as walking or jogging) and strength exercises using body weight, will be 
applied to a selected sample of the CHP population at CESFAM Externo. Its main 
advantage lies in minimizing resource use, and it has been proven to induce positive 
changes in CRF control and physical capacity improvement. 
Action Plan: 
1. Evaluation of cardiovascular risk factors and physical capacity in volunteer 
users. 
2. Written prescription of a personalized concurrent exercise protocol, adapted to 
cardiovascular risk and physical capacity levels of each user. 
3. Biweekly follow-up via phone calls to assess adherence to the protocol. 
4. Reevaluation of cardiovascular risk factors and physical capacity. 
The absence of this project would mean that CHP users would not have access to an 
essential tool for improving cardiovascular health and physical capacity, perpetuating 
current compensation levels, which are approximately 54%. Moreover, without this 
project, a crucial opportunity to align with the National Health Strategy for 2030 would 
be lost. This strategy not only advocates for lifestyle improvements and reduction of 
non-communicable chronic diseases but also emphasizes empowering individuals in 
managing their own health. Additionally, it underscores the need to implement 
evidence-based actions that enhance quality and safety in healthcare. 

2. SCIENTIFIC COMPONENT, METHODOLOGY, ETHICS, AND PLANNING 
2.1 RESEARCH QUESTION AND HYPOTHESIS 
Research Question: What is the efficacy of a personalized concurrent exercise 
prescription guide combined with pharmacological treatment, compared to 
pharmacological treatment alone, in controlling cardiovascular risk factors and 
physical capacity in adult users of the Cardiovascular Health Program at CESFAM 
Externo de Valdivia during 2024? 
Hypothesis: 
• 
H1: The efficacy of a personalized concurrent exercise prescription guide 
combined with pharmacological treatment is greater than pharmacological 
treatment alone in controlling CRF and physical capacity in adult users of the 
Cardiovascular Health Program at CESFAM Externo de Valdivia during 2024. 
(hypothesis of group difference) 
• 
H0: The efficacy of a personalized concurrent exercise prescription guide 
combined with pharmacological treatment is equal to pharmacological 
treatment alone in controlling CRF and physical capacity in adult users of the 
Cardiovascular Health Program at CESFAM Externo de Valdivia during 2024. 
(hypothesis of group difference) 
Statistical Hypothesis: 
• 
Group Difference Hypothesis: 
• 
H0: μA = μB 
• 
H1: μA > μB 
2.2 OBJECTIVES 
2.2.1 GENERAL OBJECTIVE Determine the efficacy of a personalized concurrent 
exercise prescription guide combined with pharmacological treatment, compared to 
pharmacological treatment alone, in controlling cardiovascular risk factors and 
physical capacity in adult users of the Cardiovascular Health Program at CESFAM 
Externo de Valdivia during 2024. 
2.2.2 SPECIFIC OBJECTIVES 
• 
Describe the effects of applying a personalized concurrent exercise prescription 
guide on cardiovascular risk factors in adult users of the Cardiovascular Health 
Program at CESFAM Externo de Valdivia. 

• 
Describe the effects of applying a personalized concurrent exercise prescription 
guide on physical capacity in adult users of the Cardiovascular Health Program 
at CESFAM Externo de Valdivia. 
• 
Evaluate adherence to the personalized concurrent exercise guide and 
pharmacological treatment in adult users of the Cardiovascular Health Program 
at CESFAM Externo de Valdivia. 
• 
Describe the clinical significance of interventions through effect size calculation 
and perceived clinical relevance by participants regarding the interventions. 
2.3 METHODOLOGY AND PROCEDURES 
Research Design: The research design corresponds to a Pilot Randomized Controlled 
Trial (RCT), with parallel groups and superiority. The design aligns with the general 
objective and proposed hypothesis as it will evaluate the efficacy of a personalized 
concurrent exercise prescription guide combined with pharmacological treatment, 
compared to pharmacological treatment alone, in controlling cardiovascular risk 
factors and physical capacity. 
Study Variables: Primary variables include the standard CHP control parameters: 
blood pressure, fasting glucose, total cholesterol, and triglycerides. Secondary 
variables include sociodemographic and medical background, physical activity level, 
muscular strength, cardiorespiratory capacity, body composition, adherence to the 
exercise guide, and patient perception of changes due to the intervention. 
Population: The population will consist of adult users of the CHP registered at CESFAM 
Externo de Valdivia. The research team will invite users directly during their regular 
controls at CESFAM Externo. The research team, identified as staff from Universidad 
San Sebastián, will provide detailed information about the study, the exercise 
prescription guide, program duration, benefits, and risks in a designated space. 
Interested individuals will be asked to sign an informed consent form. The recruitment 
period will be necessary to obtain the total sample, with a maximum of 1 month. If the 
sample is not obtained within this period, recruitment will be extended by 1 month. 
Selection Criteria: Inclusion: 
• 
Physically inactive (not engaging in 300 or 150 min. of moderate or vigorous 
physical activity per week, respectively, measured with the IPAQ questionnaire) 
• 
Body mass index (BMI) between 25 and 39.9 kg/m2 
• 
Registered in the Cardiovascular Health Program 

• 
Diagnosis of Hypertension with the use of 1 and/or 2 antihypertensive 
medications 
• 
Diagnosis of Type 2 Diabetes Mellitus with the use of 1 oral hypoglycemic, non-
insulin-dependent 
• 
Diagnosis of Dyslipidemia with the use of 1 lipid-lowering medication 
• 
Having a phone device 
Exclusion: 
• 
Bone disease 
• 
Ischemic disease or arrhythmia 
• 
Chronic respiratory disease 
• 
Uncontrolled chronic diseases 
• 
Inability to provide informed consent or comply with tests and exercise protocol 
for any reason 
• 
History of oncological disease or undergoing investigation for suspected 
neoplastic disease 
• 
Female participants who are pregnant 
Sample Size Calculation: The sample size calculation will be based on literature 
recommendations for pilot studies and includes: 
1. T-test – Means: difference between two independent means 
2. Type I error: 5% 
3. Statistical power: 80% 
4. Effect size (ES): 0.5 according to Cohen's classification. Using these 
parameters, the recommended total sample size is 15 subjects per group. 
Assuming a 30% dropout rate, the total population will be 39 participants. After 
the eligibility process, participants will be randomly assigned to an experimental 
group (EG) and a control group (CG) using a 1:1 ratio online system 
(https://www.randomizer.org/). Assignment concealment will be carried out by 
an investigator not involved in the clinical procedures of the RCT using opaque, 
sealed, and consecutively numbered envelopes. The random sequence and 
assignment concealment will control selection bias. 

The experimental group will receive the intervention based on the personalized exercise 
prescription guide plus their usual pharmacological treatment associated with the 
CHP, and the control group will maintain their usual pharmacological treatment 
associated with the CHP. 
Data Collection Techniques: All evaluations will be conducted pre- and post-
intervention in the experimental and control groups. 
Clinical Record Information Review: The CHP medical manager, with authorization 
from the CESFAM Externo management and approval from the Ethics Committee of the 
Valdivia Health Service, will review the clinical records of participants, gathering the 
following information: 
• 
Sociodemographic and medical background: sex, age, education level, duration 
in the cardiovascular health program, comorbidities, medications, dosage, and 
duration of medication use. These variables will be used to characterize the 
study sample. 
Cardiovascular Risk Factor Evaluation: Evaluations and user follow-up will be 
conducted by physical therapists trained in evaluation techniques, exercise 
prescription, and cardiovascular risk factors, at the Universidad San Sebastián Health 
Center located at Pérez Rosales 1095, Valdivia. A physical therapist will measure 
variables and be blinded to the participant's intervention assignment. 
Cardiovascular Variables Evaluation: Blood pressure (systolic and diastolic) and 
heart rate will be measured using an automatic monitor (Omron HEM 7130™) following 
the standard procedure in a seated position after 15 minutes of rest, conducted before 
and after the intervention. 
Metabolic Variables Evaluation: Blood Glucose: Blood glucose will be measured 
after a 12-hour fasting period using the Accu-Chek Instant device, developed by Roche 
Diabetes Care. This device is known for its speed and accuracy in measurements, 
offering results in less than four seconds and storing up to 720 results. Accu-Chek 
Instant complies with international standards ISO 15197:2013/EN ISO 15197:2015, 
ensuring reliability and precision. This device has been validated for clinical use. 
Triglycerides and Cholesterol: Triglycerides and cholesterol levels will be measured 
using the Accutrend® Plus device (Roche, Belgium), which employs an advanced 
reflectance photometry method. The device's parameters for analysis are: 
• 
Cholesterol measurement range: 150 to 300 mg/dl, with a measurement time of 
180 seconds and a required sample volume of 15 to 40 µl. 

• 
Triglycerides measurement range: 70 to 600 mg/dl, with a measurement time of 
174 seconds and a required sample volume of 10 to 40 µl. The Accutrend® Plus 
device has been validated for clinical use. 
Health-Related Physical Capacity Evaluation: Physical Activity Level: The 
International Physical Activity Questionnaire (IPAQ) will be used to estimate the 
physical activity level before the intervention. 
Isometric Muscle Strength: Handgrip Dynamometry: Handgrip strength will be 
assessed using a CAMRY dynamometer (CAMRY EH101), following the Southampton 
protocol. The procedure involves the subject sitting with their forearms supported on 
the chair, wrist at the edge of the armrest, in a neutral position with the thumb up, and 
feet on the ground. The subject is asked to squeeze the dynamometer as hard as 
possible for as long as possible. Three attempts are made with each hand, and the best 
attempt out of six is recorded. 
Cardiorespiratory Capacity: Two-Minute Step Test: Preparation: Before starting the 
test, the height the participant's knee needs to rise will be measured by running a string 
from the iliac crest to the midpoint of the patella, doubling the string and marking a 
point on the thigh indicating the knee height for the march. The height of the step will 
be transferred to the wall for the participant to reference. 
Procedure: 
• 
At the signal "go," the participant begins marching in place as many times as 
possible for 2 minutes. 
• 
Both knees should reach the indicated height, counting the number of times the 
right knee reaches the set height. 
• 
If the participant does not reach the mark, they will be asked to reduce the pace 
for a valid test without stopping the time. 
Scoring: The score will be the total number of complete steps in 2 minutes, counted as 
the number of times the right knee reaches the set height. Only one attempt will be 
made on the test day. 
Safety norms: Participants with balance issues should be near a wall or chair for 
support in case of balance loss. The examiner will supervise all participants for signs of 
excessive exertion. After the test, participants will walk slowly for one minute. 
The equation to estimate peak oxygen consumption is: VO2 (mLkg-1min-1) = 13.341 + 
0.138 * total steps – (0.183 * BMI). 

Body Composition: Height will be measured with a precision stadiometer (Seca 
Bodymeter 206), and weight, fat mass percentage, and lean mass percentage will be 
measured using a bioimpedance meter (TANITA BC-534). BMI will be estimated using 
the formula kg/m2. 
Treatment Adherence: Adherence to the treatment refers to the degree to which 
participants follow the prescribed physical exercise guide. This variable will be 
operationalized as compliance with at least 70% of the scheduled exercise sessions. 
Measurement Method: Adherence will be measured using two primary mechanisms: 
1. Biweekly Phone Calls: A follow-up protocol will be established, with calls made 
every two weeks to participants to gather self-reported compliance data with 
exercise sessions. These interactions will also identify potential barriers or 
facilitators of adherence, allowing proactive adjustments to the intervention if 
necessary. 
2. Exercise Logbooks Review: Each participant will maintain a detailed logbook of 
exercise sessions performed, including date, duration, and type of exercise. 
Reviewing these records will provide an objective measure of adherence, 
complementing the data obtained through phone calls. 
Adherence Criteria: A participant will be considered "adherent" if they comply with at 
least 70% of the scheduled exercise sessions, calculated by dividing the number of 
completed sessions by the total number of scheduled sessions and multiplying the 
result by 100. 
Global Rating Scale: The Global Rating Scale (GRS) will be applied as an essential 
instrument for evaluating the patient's perception of changes experienced in their 
health status, functionality, or symptoms. This evaluation will be conducted mainly at 
two key points: before and after the proposed clinical intervention. 
The GRS methodology involves asking patients to provide a rating of their current health 
status compared to an established reference point, which, in our case, will be the 
study's start. This comparison will allow a quantitative and qualitative appreciation of 
the changes perceived by the patient. 
To ensure a precise and adaptable evaluation, the GRS will be presented in two formats: 
1. Numerical: Offering a range that can vary, for example, from -7 (much worse) to 
+7 (much better), allowing a gradable assessment of changes. 

2. Descriptive: Providing qualitative terms such as "much worse," "no change," or 
"much better," facilitating patients' expression of change perception in a more 
narrative manner. 
The GRS implementation will not only contribute to evaluating the intervention's 
effectiveness from the patient's perspective but also offer a valuable indicator of the 
clinical impact of the treatment. This patient-centered approach is fundamental for a 
comprehensive understanding of treatment outcomes, enabling adjustments and 
improvements in therapeutic strategies based on patient experiences and feedback. 
Intervention 
Experimental Group: Application of the exercise guide plus pharmacological 
treatment. 
Exercise Guide Application: Cardiovascular Risk Classification for Exercise: 
Cardiovascular risk and physical capacity levels will be assessed using previously 
described procedures to provide a written personalized exercise protocol. 
Exercise Protocol: According to the recommendations for exercise prescription for 
people with cardiovascular risk factors published by MINSAL, a protocol will be applied 
as follows: 
• 
Protocol duration: 6 weeks. 
• 
Frequency: 3 to 5 times per week. 
• 
Exercise type: Concurrent, combining aerobic and muscular resistance 
exercises within the same program. 
Aerobic Exercise: Participants will perform 5-10 intervals/session of walking or jogging 
at moderate to high intensity, with a rating of 5 to 8 points on the modified Borg scale 
(1-10 points). Each interval will consist of 1 minute of walking or jogging, followed by 2 
minutes of inactive rest. Every 2 weeks, the load (cadence) will be adjusted due to 
normal physiological adaptations, always exercising at an intensity of 5-8 points on the 
modified Borg scale, similar to previous studies. 
Muscular Resistance Exercise: Participants will perform concentric, eccentric, 
and/or isometric contractions for 1 minute at an intensity of 5-10 according to the 
OMNI-RES scale. The rest period will last 2 minutes, and each exercise will be repeated 
3 times. Three exercises will be performed per session: squats, push-ups, and planks. 
Exercise difficulty (load) will be adjusted according to the user's abilities. The exercise 
load may be modified every two weeks according to the physiological adaptations of 

the subjects, to adjust the loads to the new thresholds, always working at an intensity 
of 5-10 on the OMNI-RES scale. 
Pharmacological Treatment: Participants will be asked to maintain their lifestyle, 
including taking prescribed medications as usual. 
Participants will be asked to complete a "control diary" with the sessions and exercises 
performed during the intervention, noting any medication changes, illnesses, and 
additional physical activity. 
Control Group: Pharmacological treatment. 
Participants in the control group will be asked to maintain their current lifestyle and 
exercise habits throughout the study, including taking prescribed medications as usual. 
They will complete a "control diary" to note any exercise, medication changes, 
illnesses, and relevant information. Once control participants complete post-
intervention evaluations, they will be offered the opportunity to complete the same 
intervention as the exercise group. 
Statistical Analysis: In this study, dependent variables will be described using mean 
and standard deviation. Normality and homoscedasticity assumptions will be verified 
using the Shapiro-Wilk test for all data. 
To identify group differences at baseline and post-intervention, the Student's t-test for 
independent samples will be used, complemented by Levene's test for variance 
comparison between groups. 
A two-way repeated measures ANOVA will be used to determine intra-group and inter-
group differences. Model effects will include Group (CG and EG), Time (Pre-test, Post-
test), and their interaction over time (Group x Time). Tukey's post hoc test will be used 
for variables with Group × Time interaction. Data analysis will be conducted by an 
investigator blinded to the intervention groups. Intention-to-treat analysis will be 
considered using the multiple imputation method for handling missing data and 
incomplete datasets. 
The clinical significance of the interventions will be determined by effect size using 
Cohen's “d” (<0.2=negligible, 0.2-0.49=small, 0.5-0.79=moderate, ≥0.8=large). The 
clinical relevance of interventions will be assessed based on perceived therapeutic 
changes by participants using the Global Rating Scale (GRS). The GRS will evaluate the 
intervention's impact on relevant domains from the user's perspective and experience, 
using a 15-point Likert scale (-7=much worse, 0=no change, +7=much better). 
Differences interpretation: 1-3 points=small, 4-5=moderate, 6-7=significant. 

All statistical analyses will be conducted using SPSS version 26 (SPSS™ Inc., Chicago, 
IL, USA). 
2.4 ETHICAL IMPLICATIONS ANALYSIS 
Risk-Benefit Analysis: This study adheres to the Declaration of Helsinki, ensuring that 
all participants provide informed consent before commencing the project. The 
intervention will be conducted in both experimental and control groups. Evaluations 
will include health status (through clinical record review), cardiovascular parameters, 
metabolic parameters, and physical capacities. These activities present minimal risk 
to participants. The intervention has been carefully designed to ensure safety, 
respecting the user's right to withdraw from the test and/or exercise program at any 
time. However, users may experience post-exercise muscle fatigue, which could last 
up to 48 hours. To mitigate this risk, education on exercise effects will be provided. 
Safety criteria for not engaging in physical exercise have been established based on the 
Ministry of Health's physical activity recommendations for individuals with 
comorbidities. 
Benefits include updating knowledge on participants' health status and physical 
capacity. Personalized physical exercise has been demonstrated as an effective tool for 
controlling cardiovascular risk factors, such as reducing blood pressure, improving 
glycemic control, lipid profile, and physical function. Consequently, the intervention 
presents a favorable risk-benefit balance due to minimal exposure to risk situations 
and the positive effects of personalized physical exercise. 
Confidentiality Protection: The clinical record review will be conducted at CESFAM 
Externo by the CHP manager, and physical evaluations will be performed at the 
Universidad San Sebastián Health Center facilities, located at Pérez Rosales 1094, 
Valdivia, by the research team. Each participant will be assigned a unique code to 
preserve anonymity. The informed consent will clarify that their data will not be used for 
purposes other than the study. The information collected will be stored in a database 
by the Principal Investigator for four years, after which it will be handed over to CESFAM. 
This information will be kept both in digital format on the Principal Investigator's 
equipment and in physical format, in file cabinets, within the Universidad San 
Sebastián, Valdivia campus, General Lagos 1163. To prevent misuse of data, only the 
research team will have access to the results, upon request to the Principal 
Investigator. 
 
 

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INFORMATION DOCUMENT FOR PARTICIPANTS AND INFORMED CONSENT FORM 
Informed Consent Document for Users of the Cardiovascular Health Program at 
CESFAM Externo 
Johnattan Cano Montoya - Universidad San Sebastián 
Efficacy of a Personalized Concurrent Exercise Prescription Guide on the Control 
of Cardiovascular Risk Factors and Physical Capacity in Adult Users of the 
Cardiovascular Health Program at CESFAM Externo de Valdivia. A Pilot 
Randomized Controlled Trial. Version 1 
This Informed Consent Document has two parts: 
• 
Information (provides information about the study) 
• 
Consent Form (to sign if you agree to participate) 
You will be given a copy of the complete Informed Consent Document. 
PART I: Information 
Introduction 
I am Johnattan Cano Montoya, working for the School of Kinesiology at Universidad San 
Sebastián. We are researching the effects of Physical Exercise on Cardiovascular Risk 
Factors and Physical Capacity. I will provide information and invite you to participate in 
this research. You do not have to decide today whether or not to participate. Before 
making your decision, you can talk to anyone you feel comfortable with about the 
research. There may be some words you do not understand. Please stop me as I 
explain, and I will take the time to explain them. If you have questions later, you can ask 
me or any team members. 
Purpose 
Hypertension, diabetes, and high cholesterol are common diseases in the region. The 
Cardiovascular Health Program you belong to helps control these diseases; however, 
physical exercise is an effective alternative to improving cardiovascular health and 
physical capacity. Therefore, the purpose of this project is to investigate whether an 
Exercise Guide applied for six weeks improves your cardiovascular health and physical 
condition. 
Type of Research Intervention 

 
This intervention will include a review of information from your clinical record, 
evaluation of your blood pressure, glucose, cholesterol, triglycerides, physical 
capacities, and global change rating, application of a personalized physical exercise 
program that you will perform at home for six weeks, biweekly phone check-ups, and a 
reevaluation of your initial data. 
Participant Selection 
We are inviting all users of the Cardiovascular Health Program at CESFAM Externo de 
Valdivia to participate in research on the effects of an exercise guide for controlling 
hypertension, diabetes, and high cholesterol. 
Voluntary Participation 
Your participation in this research is entirely voluntary. You may choose to participate 
or not. Whether you choose to participate or not, you will continue to receive all the 
services you currently receive at CESFAM, and nothing will change. You may change 
your mind later and stop participating even if you agreed before. 
Procedures and Protocol 
A. Unknown Procedures 
We need to observe the effects of an exercise guide because we do not know how 
effective it is compared to your usual treatment. To do this, we will divide the 
participants into two groups. The groups are selected randomly, like flipping a coin. All 
participants will receive the intervention; however, one group will start training within 
the next two weeks, and one group will start training in two months. The group not 
training in the first two months will undergo two evaluations measuring cardiovascular 
risk factors and physical capacities. This is the best way we have to conduct the 
research without being influenced by what we think or expect to happen. We will then 
compare whether the exercise guide produces better results than the usual treatment 
of the cardiovascular health program. 
The research team will be carefully observing you and the other participants during the 
study. If there is anything that worries or bothers you about the research, please talk to 
me or any other researchers. 
If the training causes you discomfort, we will use what is called rescue kinesitherapy. 
Kinesitherapy sessions will be provided via video call to reduce negative effects like 

 
fatigue or muscle pain. If you find that kinesitherapy sessions do not alleviate the 
discomfort and are very uncomfortable for you, we will stop the exercise sessions. 
B. Process Description 
During the research, you will follow an exercise protocol according to the exercise guide 
for six weeks. 
• 
The first session will be at the Health Center of Universidad San Sebastián, 
where your cardiovascular risk factors and physical capacity will be evaluated. 
The Center's address is Vicente Pérez Rosales 1095. 
• 
For six weeks, you will follow an exercise protocol at home based on the exercise 
guide. 
• 
Every two weeks, you will be contacted by phone to evaluate if the protocol suits 
you and your adherence to the exercise sessions. 
• 
After the six-week training period, your cardiovascular risk factors and physical 
capacity will be re-evaluated at the Health Center of Universidad San Sebastián. 
The Center's address is Vicente Pérez Rosales 1095. 
Duration 
The research will last a total of eight weeks. During this time, you will need to attend the 
Health Center of Universidad San Sebastián twice for pre- and post-intervention 
evaluations. The home-based exercise protocol will last for six weeks. The research will 
conclude after the post-intervention evaluation. 
Side Effects 
Engaging in physical exercise should not cause side effects; however, we will monitor 
this and keep a record of any unwanted effects or problems. We may stop the physical 
exercise if an unknown problem arises. If this is necessary, we will discuss it with you 
and always consult you before proceeding to the next step. 
Risks 
By participating in this research, you may be exposed to minimal risk. Possible risks for 
measuring glucose, cholesterol, and triglycerides include infection at the puncture site, 
especially if strict hygiene practices are not followed. In patients with coagulation 
disorders, there is a risk of prolonged bleeding after the puncture. Additionally, 
improper use of lancets, such as reuse or unsafe disposal, can pose risks of cross-

 
infection, highlighting the importance of using single-use lancets and properly 
disposing of them after each measurement. Regarding physical exercise, risks include 
post-exercise fatigue and/or muscle pain, which may last up to 48 hours. Although the 
likelihood of this occurring is low, you should still be aware of this possibility. To 
minimize the risk of physical exercise, you will receive education on the muscular 
effects of physical exercise and post-exercise recovery exercises; kinesitherapy 
sessions via tele-rehabilitation will be available to reduce fatigue and muscle pain if 
muscle recovery is not achieved after exercise sessions. 
Discomfort 
By participating in this research, you may experience discomfort, such as having your 
blood pressure taken. The measurement of glucose, cholesterol, and triglycerides may 
include pain and discomfort at the puncture site, resulting from the finger prick to 
obtain the blood sample. Additionally, this procedure can induce anxiety or anticipatory 
fear in some patients, especially those apprehensive about needles or medical 
procedures. Abnormal glucose measurement results can also cause stress or anxiety, 
depending on the patient's interpretation and concern about their health status. 
Additionally, traveling to the evaluation site on your own may cause discomfort. 
Benefits 
If you participate in this research, you will potentially benefit from improved physical 
condition, cardiovascular health, metabolic health, and quality of life. 
Incentives 
This research does not offer any incentives. 
Confidentiality 
Your identity will not be disclosed, and all necessary measures will be taken to protect 
the confidentiality of clinical and experimental data. You will be assigned a code to 
avoid using your personal data. The information obtained from the evaluations will be 
stored in a database created by the Principal Investigator for four years and then 
handed over to CESFAM Externo. This information will be stored in digital format (Excel) 
on the Principal Investigator's computer, which has a password provided by 
Universidad San Sebastián (USS), and in physical format, in file cabinets within the 
facilities of Universidad San Sebastián, Valdivia campus, office of the Director of the 
Kinesiology program. 

 
Sharing the Results 
The knowledge we gain from conducting this research will be shared with you before it 
becomes publicly available. Confidential information will not be shared. A report with 
the results will be provided to CESFAM Externo. After this, the results will be published 
so that other interested parties can learn from our research. 
Right to Refuse or Withdraw 
You do not have to participate in this research if you do not wish to, and refusing to 
participate will not affect your treatment at CESFAM in any way. You will still have all the 
benefits you would otherwise have at CESFAM. You may stop participating in the 
research at any time without losing your rights as a user here. Your treatment at this 
CESFAM will not be affected in any way. 
Contact Information 
If you have any questions, you can ask them now or later, even after the study has 
begun. If you want to ask questions later, you can contact the Principal Investigator: 
Johnattan Cano Montoya, Academic Researcher at the School of Kinesiology, Faculty 
of Dentistry and Rehabilitation Sciences, Universidad San Sebastián, Valdivia campus: 
cell phone: +56962382339, email: johnattan.cano@uss.cl. 
This project has been reviewed and approved by the Scientific Ethical Committee of the 
Los Ríos Health Service. This Committee is accredited and is responsible for 
safeguarding the rights of individuals as research subjects. If you wish to learn more 
about this committee, contact c.e. cecsslr@redsalud.gob.cl, phone 632281784, or visit 
Prales Building, Vicente Pérez Rosales 560, office 307, 3rd floor, Valdivia, Chile. 
PART II: Consent Form 
I have been invited to participate in a research project titled "Efficacy of a Personalized 
Concurrent Exercise Prescription Guide on the Control of Cardiovascular Risk Factors 
and Physical Capacity in Adult Users of the Cardiovascular Health Program at CESFAM 
Externo de Valdivia. A Pilot Randomized Controlled Trial." The purpose of this project is 
to investigate the efficacy of an exercise prescription guide in controlling 
cardiovascular risk factors and physical capacity. 
I understand that my cardiovascular risk factors and physical capacities will be 
evaluated, and I will follow an exercise program for six weeks. I have been informed that 
the risks are minimal and may include only muscle pain or fatigue. The potential 

 
benefits are improved physical condition, cardiovascular health, metabolic health, and 
quality of life. I will not receive any incentives for my participation. I have been provided 
with the name of a researcher who can be easily contacted using the provided name 
and contact information. 
I have read the provided information, or it has been read to me. I have had the 
opportunity to ask questions about it, and my questions have been answered 
satisfactorily. 
I voluntarily consent to participate in this research as a participant and understand that 
I have the right to withdraw from the research at any time without affecting my medical 
care in any way. 
Participant’s 
Name 
Participant’s 
Signature 
Date 
Day/Month/Year 
If illiterate I have witnessed the accurate reading of the consent document to the 
potential participant, and the individual has had the opportunity to ask questions. I 
confirm that the individual has given consent freely. 
Witness’s 
Name 
Participant’s 
Fingerprint 
Witness’s 
Signature 
Date 
Day/Month/Year 
I have read the consent document accurately or witnessed its accurate reading to the 
potential participant, and the individual has had the opportunity to ask questions. I 
confirm that the individual has given consent freely. 
Investigator’s 
Name 
Investigator’s 
Signature 
Date 
Day/Month/Year 
Name of the Establishment Director, Delegate, or Notary Signature Date 
Day/Month/Year 
A copy of this Informed Consent Document has been provided to the participant 
(initials of researcher/assistant).