Sustainable Exercise and Nutrition Programs for Managing Metabolic Disorders in Older Women
- Conditions
- Metabolic SyndromeAgingSarcopeniaObesityChronic DiseaseFrailty
- Registration Number
- NCT07015307
- Lead Sponsor
- University of Alicante
- Brief Summary
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.
- Detailed Description
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.
Primary and secondary outcomes include anthropometric measurements, body composition, handgrip strength, lower limb strength, walking speed, cardiovascular endurance, basal metabolic rate, blood pressure, blood biomarkers (glucose, cholesterol, triglycerides), fatigue perception, sleep quality, stress levels, emotional well-being, and health-related quality of life. Validated tools such as indirect calorimetry, digital hand dynamometers, functional capacity tests, and the SF-36 questionnaire will be employed.
The results are expected to support the design of sustainable, non-pharmacological strategies for the prevention and management of metabolic disorders and functional decline in aging women.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Weight Baseline (Week 0) and Week 12 Measured in kilograms using a calibrated digital scale.
Heigth Baseline (Week 0) and Week 12 Measured in centimeters using a fixed wall-mounted stadiometer.
BMI Baseline (Week 0) and Week 12 Calculated as weight (kg) divided by height squared (m²), using measurements taken as above.
Waist circunference 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 Baseline (Week 0) and Week 12 Measured using multifrequency bioelectrical impedance.
Health-related quality of life (SF-36 score) 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 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) 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 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 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 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 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 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 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) 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) 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) 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 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 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 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 Baseline (Week 0) and Week 12 Measured using indirect calorimetry
Systolic and diastolic blood pressure Baseline (Week 0) and Week 12 Assessed using an automatic digital sphygmomanometer (Omron Healthcare, Osaka, Japan), following standardized measurement protocol.
Cholesterol Baseline (Week 0) and Week 12 Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Triglycerides Baseline (Week 0) and Week 12 Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Glucose Baseline (Week 0) and Week 12 Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
European Institute Of Exercise and Health
🇪🇸Elche, Alicante, Spain