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

Universidad San Sebastián

Status: Completed

Conditions: Cardiometabolic Risk Factors

Treatments: Behavioral: High-Intensity Interval Training; Behavioral: Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06201273

1662023

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

192 participants in 3 patient groups

High-Intensity Interval Training

Experimental group

Description:

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.

Treatment:

Behavioral: High-Intensity Interval Training

Resistance Training

Experimental group

Description:

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.

Treatment:

Behavioral: Resistance Training

Control

No Intervention group

Description:

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.