Cardiometabolic Risk FactorsNCT06201273
Physical Exercise on Physiological Adaptation Capacity and Chronic Pain in Individuals With Cardiovascular Risk
A study testing High-Intensity Interval Training and Resistance Training in people with Cardiometabolic Risk Factors, run by Universidad San Sebastián at 1 site in Chile.
Trial summary
This research focuses on studying the effects of a 12-week exercise program on the health of individuals at risk of heart disease. The program includes High-Intensity Interval Training (HIIT) and Muscle Endurance Resistance Exercise (ERE). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiometabolic Risk Factors
- What is being tested?
- High-Intensity Interval Training and Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChile
- Study dates
- 1 May 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physically inactive: Not engaging in 300 minutes of moderate or 150 minutes of vigorous physical activity per week, measured with the IPAQ questionnaire.
- BMI between 25 and 39.9 kg/m².
- Belonging to the cardiovascular health program of External Family Health Center Valdivia.
- Presenting or not presenting chronic non-cancerous pain.
Who cannot join
- Bone disease.
- Ischemic disease or arrhythmia.
- Chronic obstructive pulmonary disease (COPD) or asthma.
- Uncontrolled chronic diseases.
- Individuals unable to understand instructions.
- Individuals who do not speak Spanish.
- History of previous oncological disease or under investigation for suspected neoplastic disease in any part of the body.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This research focuses on studying the effects of a 12-week exercise program on the health of individuals at risk of heart disease. The program includes High-Intensity Interval Training (HIIT) and Muscle Endurance Resistance Exercise (ERE). The researchers aim to observe the impact of these exercises on physiological adaptability, physical capacity, cardiovascular risk factors, metabolism, body composition, and chronic pain.
The participants will be inactive adults with a Body Mass Index (BMI) between 25 and 39.9, who are enrolled in a cardiovascular health program. Individuals with certain serious conditions, such as bone or heart problems, pulmonary diseases, cancer, or those who do not adequately understand instructions or Spanish, are ineligible to participate.
Patients will be selected by the program team and divided into three groups: one will perform HIIT, another will engage in ERE, and a control group will continue their usual treatment. Participants will be assessed at different times: before starting, at 4 weeks, at 8 weeks, and at the end of the program. Various health aspects will be measured, including physical activity, quality of life, physical capacity, cardiovascular risk factors, metabolism, body composition, and pain level.
- Conditions
- Cardiometabolic Risk Factors
- Being tested
- High-Intensity Interval Training, Resistance Training
- Keywords
- Exercise, High-Intensity Interval Training, Resistance Training, Interindividual Variability, Intraindividual Variability, Physiological Adaptation, Cardiometabolic Risk Factors, Pain, Chronic Pain, Musculoskeletal Pain, Pain Threshold, Pain Perception, Exercise-Induced Hypoalgesia, Metabolic Flexibility, Indirect Calorimetry, Body Composition, Cardiorespiratory Fitness, Muscle Strength
- Medical subject headings
- Motor Activity, Pain, Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
This High-Intensity Interval Training (HIIT) program, structured to span 12 weeks, incorporates three sessions per week. Each session comprises 8 to 10 exercise intervals on a cycle ergometer. During these intervals, participants are required to reach an intensity level between 8 and 10 points, based on the modified Borg scale, which ranges from 1 to 10 points. A typical interval involves 1 minute of intensive pedaling, followed by a 2-minute rest period without any activity. To facilitate progressive development, the resistance of the cycle ergometer will be adjusted biweekly to increase the pedaling challenge. Despite these adjustments, participants should consistently maintain their effort intensity within the 8 to 10 point range on the modified Borg scale for each interval.
Resistance TrainingBehavioural
This training protocol, spanning a duration of 12 weeks, consists of three weekly sessions. In each session, participants will engage in Elastic Resistance Exercises (ERE) using Theraband CLX elastic bands. The focus will be on both concentric and eccentric contractions, maintaining an intensity level of 8 to 10 as per the OMNI-RES scale. Each exercise will be conducted for 1 minute, followed by a 2-minute rest period. Each exercise will be repeated three times within the session.
The specific exercises include bicep curls, seated horizontal rows, and wide squats. To ensure proper progression and adaptation, the exercise load will be adjusted biweekly. This adjustment will be based on the physiological adaptations of the subjects to the training, aiming to recalibrate the loads to new resistance thresholds and maintain a consistent intensity of 8 to 10 on the OMNI-RES scale for each exercise.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training | Experimental | This High-Intensity Interval Training (HIIT) program, structured to span 12 weeks, incorporates three sessions per week. Each session comprises 8 to 10 exercise intervals on a cycle ergometer. During these intervals, participants are required to reach an intensity level between 8 and 10 points, based on the modified Borg scale, which ranges from 1 to 10 points. A typical interval involves 1 minute of intensive pedaling, followed by a 2-minute rest period without any activity. To facilitate progressive development, the resistance of the cycle ergometer will be adjusted biweekly to increase the pedaling challenge. Despite these adjustments, participants should consistently maintain their effort intensity within the 8 to 10 point range on the modified Borg scale for each interval. Receives: Behavioral: High-Intensity Interval Training |
| Resistance Training | Experimental | This training protocol, spanning a duration of 12 weeks, consists of three weekly sessions. In each session, participants will engage in Elastic Resistance Exercises (ERE) using Theraband elastic bands (CLX). The focus will be on both concentric and eccentric contractions, maintaining an intensity level of 8 to 10 as per the Resistance Exercise Scale (OMNI-RES). Each exercise will be conducted for 1 minute, followed by a 2-minute rest period. Each exercise will be repeated three times within the session.
The specific exercises include bicep curls, seated horizontal rows, and wide squats. To ensure proper progression and adaptation, the exercise load will be adjusted biweekly. This adjustment will be based on the physiological adaptations of the subjects to the training, aiming to recalibrate the loads to new resistance thresholds and maintain a consistent intensity of 8 to 10 on the OMNI-RES scale for each exercise. Receives: Behavioral: Resistance Training |
| Control | No intervention | Participants in the control group will be instructed to maintain their current lifestyle and exercise habits throughout the duration of the study. This includes adhering to their prescribed medication regimen as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic Blood Pressure
Pressure in the arteries during and between heartbeats. (mmHg)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Heart Rate
Number of heartbeats per minute. (bpm)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Body Composition
Percentage of Fat and Lean Mass: Proportion of fat and lean mass in the body. (%)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Metabolic Flexibility
Indirect Calorimetry: Measurement of energy expenditure and substrates balance. (kcal)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Pain Intensity:
The Chronic Pain Grade Scale is a self-report instrument assessing the intensity and disability associated with chronic pain. It comprises 8 items, 7 of which are in an 11-point Likert format, totaling a range from 0 to 70 points. The final score is derived from summing items 2 to 8.
Items 2, 3, and 4 address pain intensity, while items 5, 6, 7, and 8 pertain to disability related to chronic pain.
Chronic pain grading based on this scale is classified as:
Grade I (low intensity): considering less than 15 points in pain intensity items and less than 17 points in disability items.
Grade II (high intensity): 15 points or more in pain intensity items and less than 17 points in disability items.
Grade III (moderately limiting): 17 to 24 points in disability items.
Grade IV (severely limiting): 25 to 40 points in disability items.
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Pressure Pain Threshold (PPT):
Pressure Algometer Measurement: Minimum amount of pressure that induces pain. (kg)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Pain Characterization:
The characterization of chronic pain will be conducted using questions 15 and 16 (based on the neuropathic pain 4 questionnaire) from the 2013 validated Chilean survey of non-oncological chronic pain.
These questions allow for the categorization of pain as either somatic or neuropathic, as detailed below:
Somatic Pain: Sharp, widespread (in a nonspecific area), a specific area related to some movement, a squeeze.
Neuropathic Pain: Burning, cold pain, electric, tingling, prickling, itching, needle sensation, numbness.
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Handgrip strength
Handgrip Dynamometry: Measurement of handgrip strength. (kgf or N)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Cardiorespiratory fitness
6-minute walk test: The objective is to assess an individual's functional capacity and cardiorespiratory endurance. The primary measurement unit is the distance covered in meters during the 6 minutes
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Fasting Glucose
Blood glucose level after a fasting period. (mg/dL)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Glycated Hemoglobin (HbA1c):
Percentage of glucose-bound hemoglobin in the blood. (%)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Lipid Profile
Set of tests to measure cholesterol and triglycerides. (mg/dL)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Secondary outcomes (7)
Sociodemographic and Medical Background
- Gender: Biological classification of the individual. (No unit of measure)
- Age: Number of complete years since birth. (Years)
- Ancestry: Ethnic or racial origin of the individual. (No unit of measure)
- Education Level: Highest level of education achieved. (No unit of measure)
- Duration in Cardiovascular Health Program: Length of participation in the program. (Months or Years)
- Morbid Background: History of previous diseases and medical conditions. (No unit of measure)
- Medications and Dosage: Description of used medications and their dosages. (mg/day or as prescribed)
- Duration of Medication Use: Length of time medications have been used. (Months or Years)
Measured: Pre-Intervention: Initial assessment before the training
Physical Activity Level
The International Physical Activity Questionnaire (IPAQ) is a recognized instrument for assessing physical activity in adults. This survey outlines the frequency (measured in days per week) and duration (hours and minutes per day) of physical activities categorized into four intensity levels: sedentary, walking, moderate physical activity, and vigorous physical activity.
For each intensity level, the units of measurement are expressed in days per week and hours or minutes per day, with specific Metabolic Equivalent Task (METs) values assigned to each activity (Walking: 3.3 METs, Moderate Physical Activity: 4 METs, Vigorous Physical Activity: 8 METs). The responses can be converted into MET-minutes/week, enabling a quantitative and consistent comparison of total physical activity, encompassing various types and intensities.
Measured: Pre-Intervention: Initial assessment before the training.
Health-related quality of life
The (Short Form Health Survey - 36 is a questionnaire designed to measure health-related quality of life. It consists of 36 items covering eight health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each domain is scored separately, and the scores are transformed into a 0 to 100 scale, where a higher score indicates better quality of life or less impact of the illness in that dimension.
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Height
Individual's height. (cm)
Measured: Pre-Intervention: Initial assessment before the training.
Weight
Total body mass. (kg)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Body Mass Index
The Body Mass Index (BMI) is a metric used to assess the relationship between an individual's weight and height, thereby estimating their weight category, which can range from underweight to obesity. It is calculated by dividing a person's weight in kilograms by the square of their height in meters.
The formula is: BMI = weight (kg) / [height (m)]^2
The unit of measurement for BMI is kg/m² (kilograms per square meter).
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Waist Circumference
Measurement of the abdominal circumference. (cm)
Measured: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 May 2023
- Primary completion15 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Sebastián
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnattan Cano Montoya, Universidad San Sebastián
- Investigators
- Johnattan Cano Montoya, Principal investigator, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201273
- Sponsor's protocol ID
- 1662023
- Status last verified
- Jun 2024
- First submitted
- 22 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cano-Montoya J, Rojas Vargas M, Baez Vargas S, Nunez Vergara C, Martinez Huenchullan S, Gallegos F, Alvarez C, Izquierdo M. Impact of resistance and high-intensity interval training on body composition, physical function, and temporal dynamics of adaptation in older women with impaired cardiometabolic health: a randomized clinical trial. BMC Sports Sci Med Rehabil. 2025 Apr 11;17(1):78. doi: 10.1186/s13102-025-01119-0.
PubMed 40217506
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06201273
- Acronym / sponsor ID
- 1662023
- Conditions
- Cardiometabolic Risk Factors
- Keywords
- Exercise, High-Intensity Interval Training, Resistance Training, Interindividual Variability, Intraindividual Variability, Physiological Adaptation, Cardiometabolic Risk Factors, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Universidad San SebastiánUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research focuses on studying the effects of a 12-week exercise program on the health of individuals at risk of heart disease. The program includes High-Intensity Interval Training (HIIT) and Muscle Endurance Resistance Exercise (ERE). The researchers aim to observe the impact of these exercises on physiological adaptability, physical capacity, cardiovascular risk factors, metabolism, body composition, and chronic pain.
The participants will be inactive adults with a Body Mass Index (BMI) between 25 and 39.9, who are enrolled in a cardiovascular health program. Individuals with certain serious conditions, such as bone or heart problems, pulmonary diseases, cancer, or those who do not adequately understand instructions or Spanish, are ineligible to participate.
Patients will be selected by the program team and divided into three groups: one will perform HIIT, another will engage in ERE, and a control group will continue their usual treatment. Participants will be assessed at different times: before starting, at 4 weeks, at 8 weeks, and at the end of the program. Various health aspects will be measured, including physical activity, quality of life, physical capacity, cardiovascular risk factors, metabolism, body composition, and pain level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training | Experimental | Behavioral: High-Intensity Interval TrainingThis High-Intensity Interval Training (HIIT) program, structured to span 12 weeks, incorporates three sessions per week. Each session comprises 8 to 10 exercise intervals on a cycle ergometer. During these intervals, participants are required to reach an intensity level between 8 and 10 points, based on the modified Borg scale, which ranges from 1 to 10 points. A typical interval involves 1 minute of intensive pedaling, followed by a 2-minute rest period without any activity. To facilitate progressive development, the resistance of the cycle ergometer will be adjusted biweekly to increase the pedaling challenge. Despite these adjustments, participants should consistently maintain their effort intensity within the 8 to 10 point range on the modified Borg scale for each interval. |
| Resistance Training | Experimental | Behavioral: Resistance TrainingThis training protocol, spanning a duration of 12 weeks, consists of three weekly sessions. In each session, participants will engage in Elastic Resistance Exercises (ERE) using Theraband elastic bands (CLX). The focus will be on both concentric and eccentric contractions, maintaining an intensity level of 8 to 10 as per the Resistance Exercise Scale (OMNI-RES). Each exercise will be conducted for 1 minute, followed by a 2-minute rest period. Each exercise will be repeated three times within the session. The specific exercises include bicep curls, seated horizontal rows, and wide squats. To ensure proper progression and adaptation, the exercise load will be adjusted biweekly. This adjustment will be based on the physiological adaptations of the subjects to the training, aiming to recalibrate the loads to new resistance thresholds and maintain a consistent intensity of 8 to 10 on the OMNI-RES scale for each exercise. |
| Control | No intervention | –Participants in the control group will be instructed to maintain their current lifestyle and exercise habits throughout the duration of the study. This includes adhering to their prescribed medication regimen as usual. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physically inactive: Not engaging in 300 minutes of moderate or 150 minutes of vigorous physical activity per week, measured with the IPAQ questionnaire.
- BMI between 25 and 39.9 kg/m².
- Belonging to the cardiovascular health program of External Family Health Center Valdivia.
- Presenting or not presenting chronic non-cancerous pain.
Key exclusion criteria (7 listed)
- Bone disease.
- Ischemic disease or arrhythmia.
- Chronic obstructive pulmonary disease (COPD) or asthma.
- Uncontrolled chronic diseases.
- Individuals unable to understand instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval TrainingThis High-Intensity Interval Training (HIIT) program, structured to span 12 weeks, incorporates three sessions per week. Each session comprises 8 to 10 exercise intervals on a cycle ergometer. During these intervals, participants are required to reach an intensity level between 8 and 10 points, based on the modified Borg scale, which ranges from 1 to 10 points. A typical interval involves 1 minute of intensive pedaling, followed by a 2-minute rest period without any activity. To facilitate progressive development, the resistance of the cycle ergometer will be adjusted biweekly to increase the pedaling challenge. Despite these adjustments, participants should consistently maintain their effort intensity within the 8 to 10 point range on the modified Borg scale for each interval. | Behavioural | High-Intensity Interval Training |
| Resistance TrainingThis training protocol, spanning a duration of 12 weeks, consists of three weekly sessions. In each session, participants will engage in Elastic Resistance Exercises (ERE) using Theraband CLX elastic bands. The focus will be on both concentric and eccentric contractions, maintaining an intensity level of 8 to 10 as per the OMNI-RES scale. Each exercise will be conducted for 1 minute, followed by a 2-minute rest period. Each exercise will be repeated three times within the session. The specific exercises include bicep curls, seated horizontal rows, and wide squats. To ensure proper progression and adaptation, the exercise load will be adjusted biweekly. This adjustment will be based on the physiological adaptations of the subjects to the training, aiming to recalibrate the loads to new resistance thresholds and maintain a consistent intensity of 8 to 10 on the OMNI-RES scale for each exercise. | Behavioural | Resistance Training |
Primary outcome
Systolic and Diastolic Blood Pressure
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Pressure in the arteries during and between heartbeats. (mmHg)
Heart Rate
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Number of heartbeats per minute. (bpm)
Body Composition
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Percentage of Fat and Lean Mass: Proportion of fat and lean mass in the body. (%)
Metabolic Flexibility
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Indirect Calorimetry: Measurement of energy expenditure and substrates balance. (kcal)
Pain Intensity:
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
The Chronic Pain Grade Scale is a self-report instrument assessing the intensity and disability associated with chronic pain. It comprises 8 items, 7 of which are in an 11-point Likert format, totaling a range from 0 to 70 points. The final score is derived from summing items 2 to 8. Items 2, 3, and 4 address pain intensity, while items 5, 6, 7, and 8 pertain to disability related to chronic pain. Chronic pain grading based on this scale is classified as: Grade I (low intensity): considering less than 15 points in pain intensity items and less than 17 points in disability items. Grade II (high intensity): 15 points or more in pain intensity items and less than 17 points in disability items. Grade III (moderately limiting): 17 to 24 points in disability items. Grade IV (severely limiting): 25 to 40 points in disability items.
Pressure Pain Threshold (PPT):
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Pressure Algometer Measurement: Minimum amount of pressure that induces pain. (kg)
Pain Characterization:
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
The characterization of chronic pain will be conducted using questions 15 and 16 (based on the neuropathic pain 4 questionnaire) from the 2013 validated Chilean survey of non-oncological chronic pain. These questions allow for the categorization of pain as either somatic or neuropathic, as detailed below: Somatic Pain: Sharp, widespread (in a nonspecific area), a specific area related to some movement, a squeeze. Neuropathic Pain: Burning, cold pain, electric, tingling, prickling, itching, needle sensation, numbness.
Handgrip strength
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Handgrip Dynamometry: Measurement of handgrip strength. (kgf or N)
Cardiorespiratory fitness
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
6-minute walk test: The objective is to assess an individual's functional capacity and cardiorespiratory endurance. The primary measurement unit is the distance covered in meters during the 6 minutes
Fasting Glucose
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Blood glucose level after a fasting period. (mg/dL)
Glycated Hemoglobin (HbA1c):
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Percentage of glucose-bound hemoglobin in the blood. (%)
Lipid Profile
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Set of tests to measure cholesterol and triglycerides. (mg/dL)
7 secondary outcomes
Sociodemographic and Medical Background
Time frame: Pre-Intervention: Initial assessment before the training
Physical Activity Level
Time frame: Pre-Intervention: Initial assessment before the training.
Health-related quality of life
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Height
Time frame: Pre-Intervention: Initial assessment before the training.
Weight
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Body Mass Index
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Waist Circumference
Time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 40217506Cano-Montoya J, Rojas Vargas M, Baez Vargas S, Nunez Vergara C, Martinez Huenchullan S, Gallegos F, Alvarez C, Izquierdo M. Impact of resistance and high-intensity interval training on body composition, physical function, and temporal dynamics of adaptation in older women with impaired cardiometabolic health: a randomized clinical trial. BMC Sports Sci Med Rehabil. 2025 Apr 11;17(1):78. doi: 10.1186/s13102-025-01119-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnattan Cano Montoya principal investigator
Universidad San Sebastián
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and Resistance Training in people with Cardiometabolic Risk Factors, run by Universidad San Sebastián at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and Diastolic Blood Pressure (time frame: Pre-Intervention: Initial assessment before the training. Week 4: Mid-program evaluation. Week 8: Eight-week assessment. Post-Intervention (Week 12): Final evaluation after 12 weeks.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.