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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Pain Intensity:
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Intensity:
时间窗: 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.
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.
Fasting Glucose
时间窗: 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.
Blood glucose level after a fasting period. (mg/dL)
Glycated Hemoglobin (HbA1c):
时间窗: 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.
Percentage of glucose-bound hemoglobin in the blood. (%)
Lipid Profile
时间窗: 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.
Set of tests to measure cholesterol and triglycerides. (mg/dL)
Systolic and Diastolic Blood Pressure
时间窗: 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 in the arteries during and between heartbeats. (mmHg)
Metabolic Flexibility
时间窗: 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.
Indirect Calorimetry: Measurement of energy expenditure and substrates balance. (kcal)
Pressure Pain Threshold (PPT):
时间窗: 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 Algometer Measurement: Minimum amount of pressure that induces pain. (kg)
Pain Characterization:
时间窗: 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.
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.
Heart Rate
时间窗: 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.
Number of heartbeats per minute. (bpm)
Body Composition
时间窗: 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.
Percentage of Fat and Lean Mass: Proportion of fat and lean mass in the body. (%)
Cardiorespiratory fitness
时间窗: 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.
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
Handgrip strength
时间窗: 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 Dynamometry: Measurement of handgrip strength. (kgf or N)
次要结局
- Height(Pre-Intervention: Initial assessment before the training.)
- 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.)
- 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.)
- Body Mass Index(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.)
- Waist Circumference(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.)
研究者
Johnattan Cano Montoya
Academic Researcher
Universidad San Sebastián