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

NCT ID: NCT06201273

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

High-Intensity Interval Training

Intervention Type: 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.

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 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.

Group Type: EXPERIMENTAL

Resistance Training

Intervention Type: 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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad San Sebastián

OTHER

Sponsor Role: lead

Responsible Party

Johnattan Cano Montoya

Academic Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johnattan Cano Montoya

Role: PRINCIPAL_INVESTIGATOR

Universidad San Sebastián

Locations

Universidad San Sebastián

Valdivia, Los Ríos Region, Chile

Countries

Chile

References

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.

Reference Type: DERIVED

PMID: 40217506 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1662023

Identifier Type: -

Identifier Source: org_study_id