Physical Exercise on Physiological Adaptation Capacity and Chronic Pain in Individuals With Cardiovascular Risk

Cardiometabolic Risk Factors Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06201273
• Other study ID #: 1662023
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Universidad San Sebastián
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: January 30, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cardiometabolic Risk Factors
• Chronic Pain

Intervention

Behavioral:
• High-Intensity Interval Training
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 Training
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.

Locations

Country	Name	City	State
Chile	Universidad San Sebastián	Valdivia	Región De Los Ríos

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Sebastián

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic and Diastolic Blood Pressure	Pressure in the arteries during and between heartbeats. (mmHg)	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.
Primary	Heart Rate	Number of heartbeats per minute. (bpm)	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.
Primary	Body Composition	Percentage of Fat and Lean Mass: Proportion of fat and lean mass in the body. (%)	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.
Primary	Metabolic Flexibility	Indirect Calorimetry: Measurement of energy expenditure and substrates balance. (kcal)	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.
Primary	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.	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.
Primary	Pressure Pain Threshold (PPT):	Pressure Algometer Measurement: Minimum amount of pressure that induces pain. (kg)	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.
Primary	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.	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.
Primary	Handgrip strength	Handgrip Dynamometry: Measurement of handgrip strength. (kgf or N)	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.
Primary	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	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.
Primary	Fasting Glucose	Blood glucose level after a fasting period. (mg/dL)	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.
Primary	Glycated Hemoglobin (HbA1c):	Percentage of glucose-bound hemoglobin in the blood. (%)	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.
Primary	Lipid Profile	Set of tests to measure cholesterol and triglycerides. (mg/dL)	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	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)	Pre-Intervention: Initial assessment before the training
Secondary	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.	Pre-Intervention: Initial assessment before the training.
Secondary	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.	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	Height	Individual's height. (cm)	Pre-Intervention: Initial assessment before the training.
Secondary	Weight	Total body mass. (kg)	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	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).	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	Waist Circumference	Measurement of the abdominal circumference. (cm)	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.