Effects of Concurrent Training on Metabolic Profile, Lung Function, Quality of Life and Stress in Sedentary Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Inflammatory Profile at Week 16
研究概览
简要总结
Physical inactivity and sedentary time are highly prevalent worldwide and are associated with many adverse health outcomes. Workers adults spend two-thirds of their workday sitting, so they are particularly at risk. Exercise is considered a preventive and treatment tool for diseases, however, the effects of Concurrent Training (that is, aerobic plus resistance training) are not well established in healthy adults.
This research project aims to analyze the effects of a concurrent training program on metabolic profile, lung function, stress and quality of life, as well as body composition and physical fitness in sedentary adults.
This is a single-blinded two-arm RCT with parallel groups. After completion of baseline assessments, eligible participants will be randomized in a 1:1 ratio to participate in concurrent training group or control group. Repeat assessments will be taken immediately post 8 weeks and post 16 weeks of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with ages between 40 to 64 years old
- •Physically inactive adults
- •Full-time workers in a sedentary job
- •BMI between 18 and 35 kg/m2
- •Maintain the current diet and undergo all testing procedures
排除标准
- •Chronic disease (e.g., diabetes, cardiovascular disease, pulmonary disease)
- •Cognitive impairments and/or psychiatric conditions that could interfere with the study outcomes
- •Take any medication that could interfere with the study outcomes
- •Limitations that prevent them from practicing exercise
- •History of heart failure/myocardial infarction
- •Uncontrolled or abnormal blood pressure
研究组 & 干预措施
Control Group
Maintain their usual habits/activities, including not participate in any type of physical exercise.
Concurrent Training Group
The experimental group will perform 16-weeks of the concurrent training exercise.
干预措施: Concurrent training program (Behavioral)
结局指标
主要结局
Change from Baseline in the Inflammatory Profile at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
The cytokines IL-1β, IL-1ra, IL-10, IL-6, TNF-α, TGF-β, adiponectin and leptin will be analyzed. These outcome measures have the same units of measure (pg/ml).
Change from Baseline in Salivary Stress Hormones at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
Salivary levels of cortisol, α-amylase, immunoglobulin A, and Lysozyme will be analyzed.
Change from Baseline in the "World Health Organization Quality of Life Instruments - Bref" at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
The World Health Organization Quality of Life Instruments - Bref, assesses the subjective quality of life and consists of 26 questions with responses on a 5-point Likert scale. Each domain is made up of questions where the scores vary between 1 and 5. The mean score in each domain represents the perception of the subject of their satisfaction with each aspect of quality of life. The higher the score, the better is their perception. There are no cut-points above or below which quality of life could be classified as "poor" or "good".
Change from Baseline in the Blood Pressure at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
The systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) will be measure through an automated oscillometric cuff.
Change from Baseline in the "Satisfaction with Life" at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
The "Satisfaction with Life Scale" questionnaire consists of 5-item formulated in the positive sense, that are answered using a 7-point Likert scale, where 1=strongly disagree and 7= strongly agree. Final scores range between 5 (low satisfaction) to 35 (high satisfaction).
Change from Baseline in the Fasting Insulin at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
Insuline will be expressed in mU/L.
Change from Baseline in the "Perceived Stress" at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
The Perceived Stress Scale measures the perception of stress. Seven out of the 14-items are considered negative and seven as positive rated on a 5-point Likert scale. Final scores range between 0 to 56 points, with a higher score representing higher stress.
Change from Baseline in the "36-Item Short Form Survey (SF-36)" at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
The 36-Item Short Form Survey is a generic instrument to evaluate health-related quality of life. SF-36 comprises 36 questions that cover 8 domains of health. Response choices for the items were on 2-, 3-, 5- or 6-point scales. Two-component scores are derived from 8 subdomains: a physical component (PC) and a mental component (MC). Higher scores on all subscales represent better health and functioning (\>50).
Change from Baseline in the Lipid Profile at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
The levels of total cholesterol, LDL-C, HDL-C, triglycerides, HbA1c, and glucose will be analyzed. These outcome measures have the same units of measure (mg/dL).
Change from Baseline in the Spirometric Values at Week 16
时间窗: Baseline (Week 0) to follow-up (Week 16)
Spirometry will be performed to obtain the Forced Vital Capacity, Peak Expiratory Flow, and Forced Expiratory Volume in 1s. These outcome measures have the same units of measure, i.e., %predicted.
次要结局
- Change from Baseline in the Flexibility at Week 16(Baseline (Week 0) to follow-up (Week 16))
- Change from Baseline in the Body Composition at Week 16(Baseline (Week 0) to follow-up (Week 16))
- Change from Baseline in the Muscular Strength at Week 16(Baseline (Week 0) to follow-up (Week 16))
- Change from Baseline in the Cardiorespiratory Fitness at Week 16(Baseline (Week 0) to follow-up (Week 16))
- Change from Baseline in the Levels of Physical Activity at Week 16(Baseline (Week 0) to follow-up (Week 16))
研究者
Fernanda Maria Antunes da Silva
MSc Fernanda Silva
University of Coimbra