Clinical trial NCT06201273: Physical Exercise on Physiological Adaptation Capacity and Chronic Pain in Individuals With Cardiovascular Risk
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk Factors
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
Lead sponsor: Universidad San Sebastián
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 192
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Systolic and Diastolic Blood Pressure
timeFrame: 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.
measure: Heart Rate
timeFrame: 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.
measure: Body Composition
timeFrame: 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.
measure: Metabolic Flexibility
timeFrame: 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.
measure: Pain Intensity:
timeFrame: 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.
measure: Pressure Pain Threshold (PPT):
timeFrame: 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.
measure: Pain Characterization:
timeFrame: 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.
measure: Handgrip strength
timeFrame: 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.
measure: Cardiorespiratory fitness
timeFrame: 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.
measure: Fasting Glucose
timeFrame: 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.
measure: Glycated Hemoglobin (HbA1c):
timeFrame: 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.
measure: Lipid Profile
timeFrame: 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:
measure: Sociodemographic and Medical Background
timeFrame: Pre-Intervention: Initial assessment before the training
measure: Physical Activity Level
timeFrame: Pre-Intervention: Initial assessment before the training.
measure: Health-related quality of life
timeFrame: 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.
measure: Height
timeFrame: Pre-Intervention: Initial assessment before the training.
measure: Weight
timeFrame: 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.
measure: Body Mass Index
timeFrame: 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.
measure: Waist Circumference
timeFrame: 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.
Other outcomes:
Locations:
city: Valdivia
country: Chile
facility: Universidad San Sebastián
state: Región De Los Ríos
Study officials:
affiliation: Universidad San Sebastián
name: Johnattan Cano Montoya
role: PRINCIPAL_INVESTIGATOR
References: