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

NCT06201273 | Completed

• 1 other identifier: 1662023
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (7)

• Sociodemographic and Medical Background

  Pre-Intervention: Initial assessment before the training

• Physical Activity Level

  Pre-Intervention: Initial assessment before the training.

• Health-related quality of life

  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

  Pre-Intervention: Initial assessment before the training.

• Weight

  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.

Study Arms (3)

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.

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.

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.

Interventions

High-Intensity Interval Training BEHAVIORAL

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.

High-Intensity Interval Training

Resistance Training BEHAVIORAL

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.

Resistance Training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad San Sebastián: lead

Study Sites (1)

Universidad San Sebastián

Valdivia, Los Ríos Region, Chile

Location

Related Publications (1)

• 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.

  PMID: 40217506 DERIVED

MeSH Terms

Conditions

Motor Activity; Pain; Chronic Pain; Musculoskeletal Pain

Interventions

High-Intensity Interval Training; Resistance Training

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Johnattan Cano Montoya

  Universidad San Sebastián

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Researcher

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 11, 2024
• Study Start: May 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 30, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)