Effects of Two Modalities of Physical Exercise on Physiological Adaptation Capacity, Metabolic Flexibility, and Non-oncological Chronic Pain in Patients Living With Cardiovascular Risk Factors
Phase: NA
Conditions: Cardiometabolic Risk Factors
Sponsor: Universidad San Sebastián

 
Faculty of Dentistry and  
Rehabilitation Sciences  
Kinesiology  
Valdivia Campus 
 
 
 
 
 
PROJECT: EFFECTS OF TWO PHYSICAL EXERCISE MODALITIES ON 
WORKLOAD ADAPTATION CAPACITY, METABOLIC FLEXIBILITY, AND NON-
ONCOLOGIC CHRONIC PAIN IN PATIENTS OF THE CARDIOVASCULAR 
HEALTH PROGRAM AT THE EXTERNAL CESFAM VALDIVIA 
 
 
 
 
 
Klgo. MSc. Johnattan Cano Montoya 
Klga. MSc. Carolina Núñez Vergara 
Klgo. MSc. Sebastián Báez Vargas 
Klga. MSc. Marcela Rojas Vargas    
 
 
 
22.12.20203 
Valdivia, Chile  
 
 
 
 

Problem Statement and State of the Art 
As the global population ages, disease patterns shift, and cardiovascular risk factors 
(CRFs) increase (1). The onset of CRFs at an earlier age has been reported, and 
according to the 2017 Chilean National Health Survey, there is a high prevalence of 
physical inactivity (86.7%), overweight (39.8%), obesity (31.2%), morbid obesity 
(3.2%), suspected hypertension (27.6%), and type 2 diabetes mellitus (12.3%) (2). 
Physical inactivity, defined as not meeting international physical activity 
recommendations (≥ 150 minutes of moderate to vigorous physical activity per week, 
or achieving an energy expenditure ≥ 600 MET/min/week) (3), has been shown to 
be a predominant factor for the earlier onset of CRFs (4). Inactivity leads to early 
onset of insulin resistance at the muscular level and the shift of muscle fibers from 
oxidative to glycolytic, decreasing the use of lipids as an energy substrate. These 
unoxidized lipids accumulate in central and peripheral adipose tissue and organs as 
ectopic fat, which increases sympathetic activity and inflammatory response; 
processes associated with alterations in metabolic flexibility (5, 6) and high risk of 
hypertension, type 2 diabetes mellitus, dyslipidemia, obesity (7, 8), and non-
oncologic chronic pain (9, 10, 11). 
Specifically, metabolic flexibility is defined as the ability to efficiently adapt our 
metabolism through the detection, trafficking, storage, and utilization of energy 
substrates, depending on availability and requirements (12). It has been described 
that metabolic disorders, as mentioned earlier, limit this capacity for physiological 
adaptability (13); this metabolically 'inflexible' state is characterized by inefficient 
glucose transport, reduced fatty acid turnover, and diminished oxidative capacity, 
favoring the accumulation of ectopic lipids and the early onset of metabolic syndrome 
(14). 
Regarding non-oncologic chronic pain, it is recognized as a disease in its own right 
(15), with a prevalence of 32.1% in the Chilean population (16), becoming a public 
health issue, negatively impacting quality of life, user function, representing a high 
socioeconomic burden (17, 18). Some metabolic disorders (e.g., diabetes mellitus, 
hypertension, and obesity) have been linked to the development and progression of 
non-oncologic chronic pain (9, 10, 11). Furthermore, individuals with non-oncologic 
chronic pain and cardiovascular diseases experience greater pain severity and 
disability than those with chronic pain alone (19). People with chronic pain often 
experience functional limitation, which is associated with low levels of physical 
activity, sedentary behavior, increasing the risk of developing cardiovascular 
diseases (19). 

In this context, individuals with CRFs may enter the Cardiovascular Health Program 
(PSCV), which aims to reduce the incidence of cardiovascular events through the 
control and compensation of CRFs in primary care through the following actions: 
• 
Reducing the cardiovascular risk of controlled individuals. 
• 
Promoting healthy lifestyles. 
• 
Achieving control of risk factors. o Achieving optimal blood pressure levels. o 
Improving metabolic control in people with diabetes. o Improving cholesterol 
levels in individuals with dyslipidemia. 
Complementing the actions of the PSCV, physical exercise becomes a cornerstone 
for the control of these CRFs (20), improvement in metabolic flexibility (21), and 
reduction of non-oncologic chronic pain associated with CRFs (22, 23). Moderate-
intensity aerobic exercise for 30 to 60 minutes every day of the week has been 
described as the most used alternative for controlling these risk factors (24); 
however, achieving this volume of exercise is very difficult in a clinical setting. Since 
lifestyle change is not easy for the population, adherence to some aerobic exercise 
programs decreases up to 50% in the first 3 months (25). Factors responsible for 
this low adherence include session duration, the presence of disease or post-
exercise pain, and lack of time reported by users (26). 
Thus, time-effective exercise alternatives (≤ 10 minutes of effective work) could 
address this reported lack of time by users and achieve control of CRFs. Among the 
time-effective exercise modalities for controlling CRFs, high-intensity interval training 
(HIIT) (27) has been reported, consisting of repeated short periods of high-intensity 
exercise followed by passive or active low-intensity breaks (28), and muscle 
resistance exercises with elastic materials (ERE) which is a method that uses elastic 
devices as resistance, which are low-cost, portable, and can be used almost 
anywhere. Elastic devices allow for modulating training intensity by changing the 
resistance provided by the bands (29). 
Positive results have been reported from HIIT and ERE exercise programs for 
reducing blood pressure (27, 29), improving glycemic control (30, 31), body 
composition (27, 32), metabolic flexibility (21), physical function (32, 33), and 
reducing non-oncologic chronic pain (34, 35) in users of this cohort. 
An important aspect that reveals the true effect of an exercise program is the 
adaptations to workload understood as the physiological changes or adjustments 
resulting from a physical training program that promotes optimal functioning of the 
organism (36). Adaptations are determined by events that result in the activation 
and/or repression of specific signaling pathways that regulate exercise-induced gene 
expression and protein synthesis/degradation (37). The functional consequences of 

these adaptations are determined by the training volume, intensity, and frequency, 
and the half-life of the protein (38). Moreover, many characteristics of training 
adaptation are specific to the type of stimulus, such as the mode of exercise (38). 
HIIT-type exercise induces a variety of metabolic and morphological changes, 
including mitochondrial biogenesis, fiber type transformation from fast to slow, and 
substrate metabolism (39). In contrast, resistance exercise (ERE) stimulates the 
synthesis of contractile proteins responsible for muscle hypertrophy and increases 
the production of maximum contractile force (37, 38). 
Generally, the results of exercise programs show the final changes after an 
intervention, leaving aside the capacity for adaptation to workload during the 
intervention. The processes of adaptation to exercise are studied mainly in athletes; 
however, little is known about the adaptability capacity, in special populations, 
regarding CRFs, metabolic flexibility, physical function, and non-oncologic chronic 
pain, specifically in users belonging to the Cardiovascular Health Program of the 
External CESFAM of Valdivia, subjected to two types of exercise. 
Despite knowing the link between non-oncologic chronic pain and the presence of 
cardiovascular diseases, the individual relationship between different cardiovascular 
risk factors and pain intensity is still uncertain. 
Thus, implementing a physical exercise program associated with the PSCV will 
improve the possibility of controlling CRFs, improving metabolic flexibility, reducing 
non-oncologic chronic pain, and promoting lifestyle change difficult to achieve in 
users of this cohort. On the other hand, the External CESFAM will be recognized as 
a pioneering establishment in the implementation of non-pharmacological 
alternatives (personalized and expert-guided physical exercise) to improve the 
health and quality of life of PSCV users, which will not generate extra costs to the 
establishment for its application. 
 
Objectives  
General 
• 
Objective 1: Evaluate the effects of a 12-week HIIT and ERE program on the 
workload adaptation capacity in cardiometabolic risk factors, physical 
function, and non-oncologic chronic pain in users of the Cardiovascular 
Health Program at the External CESFAM of Valdivia. 
• 
Objective 2: Determine the relationship between cardiovascular risk factors 
and non-oncologic chronic pain in users of the Cardiovascular Health 
Program at the External CESFAM of Valdivia.  

Specific 
• 
Objective 1.1: Analyze the effects of a 12-week HIIT and ERE program on the 
workload adaptation capacity in cardiometabolic risk factors, physical 
function, and non-oncologic chronic pain in users of the Cardiovascular 
Health Program at the External CESFAM of Valdivia. 
• 
Objective 1.2: Compare the effects of a 12-week HIIT and ERE program on 
the workload adaptation capacity in cardiometabolic risk factors, physical 
function, and non-oncologic chronic pain in users of the Cardiovascular 
Health Program at the External CESFAM of Valdivia. 
• 
Objective 2.1: Determine the relationship between the number of 
cardiovascular risk factors and the presence of non-oncologic chronic pain in 
users of the PSCV at the External CESFAM of Valdivia. 
• 
Objective 2.2: Determine the relationship between the number of 
cardiovascular risk factors and the intensity of non-oncologic chronic pain in 
users of the PSCV at the External CESFAM of Valdivia. 
• 
Objective 2.3: Associate the presence of non-oncologic chronic pain with 
other chronic diseases. 
Methodology 
The project formulation, planning, and management, the application of assessments, 
and exercise protocols will be carried out by a team of kinesiologists experienced in 
physical exercise and control of CRFs, supported by the Kinesiology school of the 
Universidad San Sebastián, Valdivia campus. This project will complement the 
actions of the PSCV of the External CESFAM of Valdivia. All evaluations and 
interventions will contribute to the Monthly Statistical Register (REM) of the PSCV, 
specifically, in the REM A27 (health education) section C (group physical activity for 
the cardiovascular health program) and, depending on the case, in REM A04 section 
B: Consultation with non-medical professionals. Both records will be collected by the 
providers (USS) and sent to the PSCV reference of the External CESFAM, ideally 
on the last day of the month, to contribute to REM. The results obtained during the 
intervention could be published in press articles, conferences, and renowned 
scientific journals to disseminate the good practices carried out by the CESFAM. The 
population will correspond to adult users of the PSCV enrolled in the External 
CESFAM of Valdivia with CRFs, the sample will be obtained through a public call 
inviting participation in HIIT or ERE exercise 3 sessions weekly for 12 weeks at the 
San Sebastián University Physical Fitness and Exercise Facility. The Cardiovascular 
Health Program team (Medical Director Osvaldo Elgueta) will identify eligible users 

for the study within the records (clinical file and health controls) of the program, then 
the PSCV team will extend the invitation to users to participate in the project. 
Inclusion and Exclusion Criteria  
Inclusion: a) Being physically inactive (not performing 300 or 150 min of moderate 
or vigorous intensity physical activity respectively per week measured with the IPAQ 
questionnaire); b) BMI between 25 and 39.9 kg/m2; c) Belonging to the 
cardiovascular health program of the External CESFAM of Valdivia d) Presenting 
with or without non-oncologic chronic pain.  
Exclusion: a) Bone disease; b) Ischemic disease or arrhythmia and c) Chronic 
respiratory disease d) Uncontrolled chronic diseases f) People unable to understand 
instructions, g) People who do not speak Spanish h) History of previous oncological 
disease or under study for suspected neoplastic disease in any part of the body i) 
Low adherence to training (< 70% or non-attendance at 4 continuous sessions).  
Included users will be divided into 3 groups: HIIT, ERE, and Control. All subjects will 
be evaluated at four times: pre-intervention (week 0 – time 1), week 4 (time 2), week 
8 (time 3), and post-intervention (week 12 – time 4). Only the evaluation of metabolic 
flexibility and direct oxygen consumption will be carried out pre (week 0) and post-
intervention (week 12). 
Data Collection Techniques and Instruments 
Clinical Record Information Collection The following information will be obtained from 
each participant's clinical record: 
• 
Sociodemographic Background: o Gender o Age o Ancestry o Education 
• 
Medical Background o Time within the cardiovascular health program o 
Morbid history o Medications and dosage o Time using medications o 
Laboratory tests (fasting glucose, glycosylated hemoglobin, lipid profile)  
Physical Activity Level and Quality of Life  
The international physical activity questionnaire (IPAQ) (40) will be applied to 
estimate the level of physical activity prior to the intervention. Health-related quality 
of life will be measured using the SF36 questionnaire (41) before and after the 
intervention.  
Physical Function Physical function will be measured through the Six-Minute Walk 
Test, and grip dynamometry.  
Six-Minute Walk Test 

The Six-Minute Walk Test (6MWT) is a simple and effective submaximal exercise 
test used to assess aerobic functional capacity, especially in patients with 
cardiopulmonary and respiratory diseases. The main objective of this test is to 
measure the distance an individual can walk over a span of six minutes on a flat, 
hard surface. This test is widely used because it is easy to perform, does not require 
sophisticated equipment, and reflects activities of daily living. 
The general protocol of the 6MWT includes the following steps: 
1. Preparation: Before the test, the procedure is explained to the patient, and 
consent is obtained. Baseline measurements such as heart rate, blood 
pressure, and oxygen saturation should be recorded. 
2. Instructions: The patient is instructed to walk at their own pace but to try to 
cover the greatest distance possible in six minutes. They are allowed to slow 
down or stop if necessary. 
3. Conducting the Test: During the test, the patient walks along a marked 
hallway, turning around at the end of each stretch. The evaluator follows the 
patient to assist if necessary but without encouragement to not influence 
performance. 
4. Post-test: Immediately after the test, heart rate, blood pressure, and oxygen 
saturation are re-measured. The total distance covered is also recorded. 
5. Results Analysis: The distance walked is compared to reference values based 
on the patient's age, gender, and other variables to assess their functional 
capacity. 
Grip Dynamometry 
Grip strength will be assessed using the CAMRY Model EH101 dynamometer (46) 
following the Southampton protocol. The procedure begins with the subject seated 
with forearms resting on the chair, the wrist just over the end of the chair arm, in a 
neutral position, with the thumb up and feet flat on the floor, they are asked to 
squeeze the dynamometer as hard as they can for as long as they can. Three 
attempts will be made with each hand and the best attempt of the 6 total will be 
recorded (47). 
Metabolic Flexibility – Indirect Calorimetry 
To assess the balance of energy substrates during exercise, indirect calorimetry 
measurement will be used; this measurement provides minute-to-minute energy 
expenditure data that make it the most valuable tool for distinguishing the various 
components of energy expenditure associated with the energy cost of a given activity 
(48). 

Body Composition and Waist Circumference  
Height will be measured using a precision stadiometer 0.1 cm (Seca Bodymeter 206) 
(49), weight, percentage of fat and lean mass will be measured using a 
bioimpedance meter (TANITA BC-534) (50). BMI will be estimated using the kg/m2 
formula. Waist circumference will be measured at the midpoint between the costal 
margin and the iliac crest, with a non-deformable precision tape measure 0.1 cm 
Seca 201(49). It will be performed in a standing position, and at the end of a normal 
expiration.  
Cardiovascular Parameters  
Systolic and diastolic blood pressure and heart rate will be measured using an 
automatic monitor (Omron HEM 7130™; Omron Healthcare Inc., Lake Forest, IL) 
(51) at rest following the standard seated procedure after 15 minutes of rest, being 
done before and after 15 min of each session. 
 
Metabolic Parameters 
Fasting glucose, cholesterol, and triglyceride values will be obtained through tests 
requested in the controls of the Cardiovascular Health Program. 
 
Pain Intensity 
 
The Chronic Pain Grading Scale will be applied to assess pain intensity (52). 
 
Pressure Pain Threshold 
 
The Pressure Pain Threshold (PPT) is defined as the minimum amount of pressure 
that elicits the first sensation of pain, and will be measured using a pressure 
algometer (53). 
 
Pain Characterization 
 
The modified DN4 questionnaire will be applied to determine the characteristics of 
pain prior to the intervention (54). 
 
 
Adaptation Capacity to Workload 
 
The capacity to adapt to workloads will be evaluated through the changes observed 
in the tests described above at four times: pre-intervention, week 4, week 8, and 
post-intervention (week 12). 

High-Intensity Interval Training (HIIT) 
 
During HIIT, 8-10 intervals/session will be performed on a cycle ergometer, at an 
intensity of 80-100% of the theoretical maximum heart rate (MHR) according to 
Karvonen, equating to a bicycle load of 8 to 10 points on the modified Borg scale of 
1-10 points (55). Each interval will consist of 1 minute of cycling, followed by 2 
minutes of inactive rest, similar to previous protocols (27). Every two weeks, the 
bicycle load will be adjusted (increasing the resistance to pedaling of the bicycle) 
due to normal physiological adaptations and improvement of the patient's baseline 
threshold, always exercising the patient in each effort interval at a muscular intensity 
of 8 to 10 points according to the modified Borg scale similar to previous studies 
(27). 
 
Resistance Exercise with Elastic Materials (REM) 
 
During REM, participants will perform concentric and eccentric contractions with 
Theraband CLX elastic bands for 1 minute at an intensity of 8-10 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: bicep curls, horizontal rowing 
in a chair, and wide squat. The exercise load will be modified every two weeks 
according to the physiological adaptations of the subjects to the training, in order to 
adjust the loads to the new thresholds and always work at an intensity of 8-10 on the 
OMNI-RES scale. 
 
Control Group: 
Participants in the control group will be requested to maintain their current lifestyle 
and exercise habits throughout the duration of the study. This includes adhering to 
their usual regimen of prescribed medication. 
 
 
Statistical Analysis 
 
The sample size will be calculated as follows: (1) ANOVA for repeated measures 
with intra-inter-group interaction, (2) three groups, (3) type I error: 5%, (4) type II 
error: 20%, (5) statistical test power: 80%, and (6) effect size (ES): 0.10 according 
to Cohen's classification (1988). Using these parameters, the total sample size 
recommended by G*Power software (Version 3.1.9.2) was 174 (58 per group). 
Assuming a 10% dropout, the total was calculated at 192, with 64 participants 
randomly assigned to each group. The concealment of allocation will be conducted 
by a researcher not involved in the clinical procedures of the intervention using the 

method of opaque, sealed, and consecutively numbered envelopes. The random 
sequence and allocation concealment allow for the control of selection bias. 
 
For enhanced bias control, the data analysis will be performed by a researcher 
blinded to the intervention groups. Dependent variables will be described in terms of 
mean and standard deviation. Assumptions of normality and homoscedasticity for all 
data will be verified using the Shapiro-Wilk test and the Levene's test, respectively. 
To address General Objective 1, the Student's t-test will be used to detect baseline 
differences between groups, and a repeated measures ANOVA (group x time) to 
determine differences in all dependent variables between training prior, and at 4, 8, 
and 12 weeks afterwards. The Bonferroni post hoc test will be used to test 
differences between groups. Additionally, the Cohen's d test will be applied to 
determine the effect size. To address the General Objective, the Pearson correlation 
test will be used to determine the relationship between MHR and the presence and 
intensity of non-oncological chronic pain. The level for statistical significance was set 
at p < 0.05. Statistical analyses will be performed using SPSS software version 21 
(SPSS™ Inc., Chicago, IL, USA). 
 
Expected Results 
 
Following the training application, we expect that the measured variables will modify 
their values on average in favor of greater adaptation to workloads, improved health 
condition, better quality of life, and a reduction in the pharmacological arsenal used 
before the intervention. Additionally, implementing a physical exercise program 
associated with the PSCV will improve the possibilities of controlling MHR and 
promote lifestyle changes in users of this population. Moreover, the CESFAM 
Externo will be showcased as a pioneering establishment in the implementation of 
non-pharmacological alternatives (personalized physical exercise and guided by 
experts in physical exercise and health) to improve the health and quality of life of 
PSCV users, which will not generate extra expenses for its application. On another 
front, the results obtained during the intervention could be published in press articles, 
congresses, and scientific journals to disseminate the good practices carried out by 
CESFAM and the Universidad San Sebastián. 
 
Work Plan (Gantt Chart)  
 
Month 1  
 
• Logistical meeting and coordination with the head of the Cardiovascular Health 
Program and Director.  
• Presentation of the project to the Scientific Ethics Committee  

 
Month 2  
• Patient eligibility process o Contact from CESFAM to eligible users o On-site 
recruitment at CESFAM Externo or invitation to the project by phone call o Signing 
of informed consent o Collection of sociodemographic information  
 
Month 3  
 
• Pre-intervention evaluation (IPAQ, SF36, Cardiometabolic Variables, Metabolic 
Flexibility, and Pain)  
• Exercise familiarization  
 
Months 4, 5, and 6  
 
• Application of training protocols  
• Evaluation of workload adaptation every 4 weeks, until week 12 (Cardiometabolic 
Variables, Pain).  
 
Month 7  
 
• Tabulation of results in Excel spreadsheets  
• Delivery of preliminary results to CESFAM Externo.  
• Time for unforeseen events in the application of the protocol 
 
 
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PARTICIPANT INFORMATION DOCUMENT AND INFORMED CONSENT FORM 
 
Informed Consent Document for Users of the External CESFAM Cardiovascular Health 
Program 
 
Johnattan Cano Montoya - Universidad San Sebastián 
 
Effects of Two Modalities of Physical Exercise on Workload Adaptation Capacity, 
Metabolic Flexibility, and Non-Oncologic Chronic Pain in Patients of the External CESFAM 
Cardiovascular Health Program of Valdivia. Version 1 
 
This Informed Consent Document consists of two parts: 
• 
Information (providing details about the study) 
• 
Consent Form (to be signed if you agree to participate) A copy of the complete 
Informed Consent Document will be provided to you. 
 
PART I: Information 
 
Introduction 
 
I am Johnattan Cano Montoya, working with the School of Kinesiology at Universidad San 
Sebastián. We are researching the effects of Physical Exercise on Cardiovascular Risk Factors. I 
will provide you with information and invite you to participate in this research. You do not need to 
decide today whether to participate. Before deciding, you may discuss the research with someone 
you feel comfortable with. If there are words you do not understand, please stop me as I inform 
you to allow time for explanation. If you have questions later, you can ask me or members of the 
team. 
 
Purpose 
 
Hypertension, diabetes, high cholesterol, and pain are common diseases in the region. The 
cardiovascular health program you belong to helps control these diseases, but physical exercise 
is an effective alternative that could enhance the program's actions. Therefore, the purpose of this 
project is to investigate the relationship between the presence and intensity of pain and chronic 
diseases and the role of a 12-week exercise program as therapy to improve physical condition, 
cardiovascular health, and quality of life. 
 
Type of Research Intervention 
 
This intervention will include reviewing information from your clinical file, evaluating your physical 
abilities, an intervention with physical exercise three times a week for 12 weeks, and re-evaluations 
every four weeks of the data taken at the beginning. 
Participant Selection 
We are inviting all users of the External CESFAM Cardiovascular Health Program of Valdivia to 
participate in the research on the effects of an exercise program for controlling hypertension, 
diabetes, and high cholesterol. 

 
Voluntary Participation 
 
Your participation in this research is entirely voluntary. You can choose whether or not to 
participate. Whether you choose to participate or not, all services you receive at CESFAM will 
continue unchanged. You can change your mind later and stop participating even after you have 
previously accepted. 
Procedures and Protocol 
 
A. Unknown Procedures 
 
We need to observe the effects of two types of training because we do not know how effective they 
are compared to your usual treatment. To do this, participants will be divided into three groups. 
The groups are selected at random, like flipping a coin. All participants will receive the intervention, 
but two groups will start training within the next two weeks, and one group will start training in three 
more months. The group that will not train in the first three months will have monthly follow-ups 
where their physical capabilities will be evaluated, and physical activity recommendations will be 
given. This is the best way we have to conduct research without being influenced by what we think 
or expect to happen. Then we will compare which of the two types of training gives better results. 
The research team will be closely observing you and the other participants during the study. If there 
is anything that concerns or bothers you about the research, please talk to me or one of the other 
researchers. 
If the training causes discomfort, we will use what is called rescue kinesiotherapy. Kinesiotherapy 
sessions will be provided to reduce the negative effects of training, such as fatigue or muscle pain. 
If you find the kinesiotherapy sessions do not stop the discomfort and are too uncomfortable for 
you, we will stop the exercise sessions. 
 
B. Process Description 
 
During the research, you will participate in 39 sessions at the San Sebastián University Health 
Center. 
• 
The first session will be at the Health Center of Universidad San Sebastián. Here, an 
evaluation of resting energy expenditure called Indirect Calorimetry will be carried out. The 
center's address is Vicente Pérez Rosales 1095. 
• 
The second session will take place at the San Sebastián University Health Center in 
Valdivia. Here, the level of physical activity, health-related quality of life, vital signs, body 
composition, muscle strength, pain, and cardiorespiratory capacity will be evaluated. The 
gym's address is Viel 99, Isla Teja. 
• 
Sessions 3 to 39 will be held at the San Sebastián University Health Center. The training 
will be applied. 
• 
Sessions 15, 27, and 39 will be held at the San Sebastián University Health Center. The 
level of physical activity, health-related quality of life, vital signs, body composition, muscle 
strength, pain, and cardiorespiratory capacity will be reevaluated. 
 
Duration 
 
The research will last a total of three months. During this time, you will need to attend the San 
Sebastián University Health Center three days a week, for one hour each day, and one session at 
the University Health Center of Universidad San Sebastián. In total, you will be asked to attend 39 
sessions over three months. At the end of the three months of intervention, the research will 
conclude. 
 
Side Effects 
 
Performing physical exercise should not report side effects, however, we will monitor this and keep 
a record of any unwanted effects or problems. We may stop applying physical exercise if an 

unknown problem appears. If this is necessary, we will discuss it with you, and you will always be 
consulted before continuing with the next step. 
 
Risks 
 
By participating in this research, you may be exposed to minimal risk. The possible risks of  
performing physical exercise include post-exercise fatigue and/or muscle pain that could last up to 
48 hours. Although the likelihood of this happening is low, you should still be aware of this 
possibility. To minimize the risk, you will receive education on the muscular effects of physical 
exercise and post-exercise regenerative exercises; you will have kinesiotherapy sessions aimed 
at reducing fatigue and muscle pain in case of no muscle recovery post-exercise sessions. 
 
Discomforts 
 
By participating in this research, you may experience discomforts such as having your blood 
pressure and oxygen saturation taken several times, in addition to traveling on your own to the 
exercise location. 
 
Benefits 
 
If you participate in this research, you may potentially benefit from improved physical condition, 
cardiovascular, metabolic health, and health-related quality of life. 
 
Incentives 
 
This research does not offer any incentives. 
 
Confidentiality 
 
Your identity will not be disclosed, taking all necessary measures to protect the confidentiality of 
clinical and experimental data. A code will be assigned to you, avoiding the use of your personal 
data. The information obtained from the evaluations will be stored in a database created by the 
Responsible Researcher for a period of 4 years, after which it will be handed over to the External 
CESFAM. This information will be stored in digital format (Excel) on the Responsible Researcher's 
computer, which has an access password granted by the USS (Universidad San Sebastián), and 
in physical format, in filing cabinets within the premises of Universidad San Sebastián, Valdivia 
campus, office of the director of the Kinesiology career. 
 
Sharing the Results 
 
The knowledge we gain from conducting this research will be shared with you before it becomes 
available to the public. No confidential information will be shared. There will be small meetings in 
the community, and these will be announced. After these meetings, 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 you in any way in being treated at CESFAM. You will still have all the benefits you would 
otherwise have at CESFAM. You can stop participating in the research at any time you wish without 
losing your rights as a user here. Your treatment at this CESFAM will not be affected in any way. 
 
Who to Contact 
 
If you have any questions, you can ask them now or later, even after the study has started. If you 
wish to ask questions later, you can contact the Responsible Researcher: Johnattan Cano 
Montoya, Academic Researcher of the School of Kinesiology, Faculty of Dentistry and 
Rehabilitation Sciences, Universidad San Sebastián Seda Valdivia: cell  one: +56962382339 

email: johnattan.cano@uss.cl. 
 
This project has been reviewed and approved by the Scientific Ethical Committee of the 
Valdivia Health Service. This Committee is accredited and functions to safeguard the rights 
of people as research subjects. If you wish to learn more about this committee, contact 
telephone: 63-2281784 or at Prales Building, Vicente Pérez Rosales 560, office 307, 3rd 
Floor, Valdivia, Chile. 
 
 
 
PART II: Informed Consent Form 
 
I have been invited to participate in a research project titled "Effects of Two Physical Exercise 
Modalities on Workload Adaptation Capacity, Metabolic Flexibility, and Non-Oncologic Chronic Pain 
in Patients of the Cardiovascular Health Program at the External CESFAM of Valdivia." The 
purpose of this project is to investigate whether there is a relationship between the presence and 
intensity of pain and chronic diseases, and the role of a 12-week exercise program as a therapy to 
improve my physical condition, cardiovascular health, and quality of life. 
 
I understand that my physical abilities will be assessed and I will undergo an exercise program 
three times a week for three months. 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 and metabolic health, and health-related quality of life. I will not receive incentives 
for my participation. I have been provided the name of a researcher who can be easily contacted 
using the name and address given to me for that person. 
 
I have read or had the information provided to me read. I have had the opportunity to ask questions 
about it and my questions have been satisfactorily answered. 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 
 
For Illiterate Participants 
 
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 freely given 
consent. 
 
Witness's Name 
Participant's Fingerprint Witness's Signature 
Date  
 
I have read accurately or witnessed the accurate reading of the informed consent document for the 
potential participant, and the individual has had the opportunity to ask questions. I confirm that the 
individual has freely given consent. 
 
Researcher's Name 
Researcher's Signature  
Date 
 
Name of the Head of the Establishment, Delegate or Minister of Faith  
Signature 
Date (Day/Month/Year) 

 
A copy of this Informed Consent Document has been provided to the participant (Initials of 
researcher/assistant)