Effectiveness of a Physical Exercise Prescription Program in Primary Care to Improve Physical Fitness and Quality of Life in Adults Aged 65 Years and Older in a Rural Health Area: PREFIS-AP Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change in Quality of Life
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of an individualized Physical Exercise Prescription Program delivered in Primary Care for adults aged 65 years and older. The intervention includes a structured assessment of physical fitness, muscle function and mass, physical activity level, and quality of life, followed by a tailored exercise plan encompassing aerobic, strength, respiratory, flexibility, and balance training. Outcomes will be compared with a control group receiving standard health advice to walk briskly for at least 30 minutes daily. The study also explores associations between polypharmacy, muscle function, physical performance, and quality of life.
详细描述
Sedentary behavior is strongly associated with multiple adverse health outcomes, particularly in older adults. Conventional lifestyle advice alone has shown limited effectiveness in increasing physical activity levels. Exercise prescription delivered through structured evaluation, individualized planning, and scheduled follow-up may lead to clinically significant improvements in physical function and quality of life.
This study will recruit 210 adults aged ≥65 years from a rural Primary Care center. Participants will undergo baseline assessments including sociodemographic variables, anthropometric measures, muscle strength (handgrip dynamometry and chair stand test), aerobic capacity (6-minute walk test), muscle mass (calf circumference and ultrasound of rectus femoris), physical activity level (GPAQ), and quality of life (SF-36). After randomization (1:1), the intervention group will receive a personalized exercise prescription generated through the MEDORA Primary Care electronic system and supervised by a qualified Exercise Technician. The control group will receive routine health advice.
After three months, all participants will be reassessed using the same measures. The study will analyze the effect of the intervention on physical fitness, physical activity, muscle mass and function, and quality of life, including sex-specific differences and the role of polypharmacy. The project incorporates a partial masking strategy and uses REDCap for data management and anonymization.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years
- •Motivated to participate and able to provide informed consent
- •Able to attend baseline assessment and follow-up
- •Clinical stability allowing participation in exercise evaluation
排除标准
- •Recent myocardial infarction
- •Unstable angina
- •Uncontrolled arrhythmias (symptomatic or hemodynamically compromising)
- •Acute endocarditis, myocarditis, or pericarditis
- •Severe or symptomatic aortic stenosis
- •Uncontrolled heart failure
- •Recent pulmonary thromboembolism or pulmonary infarction
- •Lower-limb thrombosis
- •Severe aortic stenosis or suspected dissecting aortic aneurysm
- •Uncontrolled asthma
- •Pulmonary edema
- •Acute respiratory failure
- •Acute non-cardiopulmonary illness that impairs exercise capacity (e.g., infection, thyrotoxicosis, acute renal failure)
- •Mental disorder that prevents adequate cooperation.
研究组 & 干预措施
Physical Exercise Prescription Program
Participants undergo a structured, individualized 12-week Physical Exercise Prescription Program developed after a comprehensive baseline assessment of physical fitness, muscle strength, muscle mass, and physical activity levels. The prescription is generated through the MEDORA Primary Care electronic system and includes five exercise components.
干预措施: Physical Exercise Prescription Program (Behavioral)
Standard Health Advice
Participants receive general advice to engage in brisk walking on flat terrain for at least 30 minutes daily, consistent with typical Primary Care counseling. No structured exercise plan is provided.
结局指标
主要结局
Change in Quality of Life
时间窗: Baseline to 3 months.
Quality of Life will be measured by the SF-36 questionnaire. The SF-36 questionnaire is a widely used, patient-reported questionnaire measuring health-related quality of life. It uses points to assess health, with responses on Likert scales (e.g., 0 to 100) transformed into scores for 8 health domains: physical functioning, role limitations (physical/emotional), bodily pain, general health, vitality, social functioning, and mental health, where higher scores mean better health, ranging from 0 (maximum disability) to 100 (no disability).
次要结局
- Physical Activity Level (GPAQ)(Baseline to 3 months.)
- Aerobic Capacity (6-Minute Walk Test)(Baseline to 3 months.)
- Muscle Strength - Handgrip Dynamometry(Baseline to 3 months.)
- Muscle Strength - Chair Stand Test(Baseline to 3 months.)
- Muscle Mass - Calf Circumference(Baseline to 3 months.)
- Muscle Mass - Ultrasound of Rectus Femoris(Baseline to 3 months.)
- Sex Differences in Response to the Exercise Prescription Program (Standardized Change Score)(Baseline to 3 months.)
- Correlation Between Polypharmacy and Change in Handgrip Strength(Baseline to 3 months)
- Correlation Between Polypharmacy and Change in Appendicular Skeletal Muscle Mass(Baseline to 3 months)
- Correlation Between Polypharmacy and Change in Physical Performance(Baseline to 3 months)
- Correlation Between Polypharmacy and Change in Quality of Life(Baseline to 3 months)