Study and Design of New Sustainable Exercise and Dietary-nutritional Programs for the Treatment of Metabolic Disorders in Elderly Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
This study aims to evaluate the impact of sustainable diet and exercise programs on metabolic health and quality of life in older women. Participants will be assigned to different intervention groups including supervised physical training, personalized dietary guidance based on the Mediterranean dietary pattern, or a combination of both. The programs will be implemented over several weeks, with continuous monitoring of variables such as body composition, functional capacity, strength, fatigue perception, sleep quality, and emotional well-being. The project also includes the development of a digital platform to support remote engagement and long-term health behavior change.
详细描述
This is a multi-phase interventional study designed to evaluate the impact of sustainable dietary and physical activity programs on metabolic health, functional capacity, and quality of life in older women. The target population includes women aged 65 and older, both with and without metabolic alterations.
The study comprises three phases:
Phase 1 includes initial assessments and an observational comparison between healthy older women and those with metabolic alterations.
Phase 2 implements three 12-week intervention programs: (1) a sustainable dietary strategy based on the Mediterranean diet, (2) a structured physical exercise program (both supervised and unsupervised), and (3) a combined intervention integrating both diet and exercise. Participants are assigned to groups based on their health status and intervention type.
Phase 3 focuses on knowledge transfer through the development of practical guidelines and a digital platform to facilitate remote monitoring and promote long-term adherence to healthy behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researcher performing the statistical analysis will not know which intervention each group received.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 65 years or older
- •Ability to walk independently or with assistive device
- •Capacity to provide informed consent
- •For groups with metabolic alterations: clinical diagnosis of metabolic syndrome based on standard criteria
- •For healthy volunteers: absence of diagnosed metabolic or cardiovascular disease
排除标准
- •Diagnosed cognitive impairment or dementia
- •Unstable cardiovascular, respiratory, or musculoskeletal condition
- •Participation in another structured lifestyle intervention during the study
- •Any medical contraindication for physical exercise
- •Severe mobility limitation preventing safe participation
结局指标
主要结局
Weight
时间窗: Baseline (Week 0) and Week 12
Measured in kilograms using a calibrated digital scale.
Heigth
时间窗: Baseline (Week 0) and Week 12
Measured in centimeters using a fixed wall-mounted stadiometer.
BMI
时间窗: Baseline (Week 0) and Week 12
Calculated as weight (kg) divided by height squared (m²), using measurements taken as above.
Waist circunference
时间窗: Baseline (Week 0) and Week 12
Measured in centimeters using a flexible, non-elastic anthropometric tape at the midpoint between the last rib and the iliac crest.
Body fat percentage
时间窗: Baseline (Week 0) and Week 12
Measured using multifrequency bioelectrical impedance.
Health-related quality of life (SF-36 score)
时间窗: Baseline (Week 0) and Week 12
Measured using the 36-Item Short Form Health Survey (SF-36), validated in Spanish (Vilagut, 2005), which assesses 8 domains of quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Fatigue and perceived effort
时间窗: Baseline (Week 0) and Week 12
Measured with the Fatigue Severity Scale (FSS), a validated questionnaire that includes 9 items rated on a 7-point Likert scale. Scores range from 1 to 7, with higher scores indicating greater fatigue and perceived effort.
Energy intake (kcal/day)
时间窗: Baseline (Week 0) and Week 12
Total daily energy intake assessed through 3-day dietary records and a validated food frequency questionnaire for the Spanish population. Energy intake will be calculated in kilocalories per day (kcal/day) using standardized nutrient databases.
Carbohydrate intake
时间窗: Baseline (Week 0) and Week 12
Average daily carbohydrate intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater carbohydrate consumption.
Protein intake
时间窗: Baseline (Week 0) and Week 12
Average daily protein intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater protein consumption.
Fat intake
时间窗: Baseline (Week 0) and Week 12
Average daily fat intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater fat consumption.
Daily step count
时间窗: Baseline (Week 0) and Week 12
Average number of steps per day measured with an accelerometer-based activity tracker. Higher scores indicate higher physical activity levels.
Active minutes per day
时间窗: Baseline (Week 0) and Week 12
Daily time spent in moderate to vigorous physical activity, measured in minutes per day using an accelerometer. Higher scores indicate higher physical activity levels.
Sedentary time per day
时间窗: Baseline (Week 0) and Week 12
Average number of minutes per day spent in sedentary behavior (e.g., sitting or lying down), measured via accelerometer. Higher scores indicate greater sedentary behavior (worse outcome).
Sleep quality (PSQI total score)
时间窗: Baseline (Week 0) and Week 12
Measured using the Pittsburgh Sleep Quality Index (PSQI), which provides a global score based on 19 items grouped into 7 components. Total scores range from 0 to 21, where higher scores indicate poorer sleep quality. PSQI score (range: 0-21).
Gait speed (10-meter walk test)
时间窗: Baseline (Week 0) and Week 12
Assessed by measuring the time to walk 10 meters at usual pace using infrared photocells (Chronojump, Barcelona, Spain).
Cardiovascular endurance (6-minute walk test)
时间窗: Baseline (Week 0) and Week 12
Evaluated using the 6-minute walk test (6MWT). Distance walked in 6 minutes on a flat surface, timed with a chronometer. Conducted on the athletics track at the University of Alicante.
Handgrip strength
时间窗: Baseline (Week 0) and Week 12
Measured using a digital hand dynamometer. Maximum isometric voluntary contraction recorded in the dominant hand.
Lower-limb isometric strength
时间窗: Baseline (Week 0) and Week 12
Assessed through maximum isometric voluntary contraction of the lower limbs using Kinvent force sensors and biofeedback platform.
Sarcopenia diagnosis
时间窗: Baseline (Week 0) and Week 12
Assessed according to the European Working Group on Sarcopenia in Older People criteria (EWGSOP, Cruz-Jentoft et al., 2010), using muscle strength, muscle mass and functional performance.
Basal metabolic rate
时间窗: Baseline (Week 0) and Week 12
Measured using indirect calorimetry
Systolic and diastolic blood pressure
时间窗: Baseline (Week 0) and Week 12
Assessed using an automatic digital sphygmomanometer (Omron Healthcare, Osaka, Japan), following standardized measurement protocol.
Cholesterol
时间窗: Baseline (Week 0) and Week 12
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Triglycerides
时间窗: Baseline (Week 0) and Week 12
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Glucose
时间窗: Baseline (Week 0) and Week 12
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
次要结局
未报告次要终点
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Alejandro Martínez-Rodríguez
University of Alicante