This study aims to assess the effects of physical activity in counteracting muscle aging. The increasing life expectancy worldwide has led to a rise in age-related muscle decline, which negatively impacts strength, function, and overall quality of life. Sedentary lifestyles further accelerate this process, increasing the risk of frailty, falls, fractures, and disability. This randomized controlled trial (RCT) will investigate whether a structured exercise program can help reduce muscle deterioration. The study will involve 200 participants, divided into three age groups: i) Young adults (18-35 years); ii) Middle-aged adults (35-65 years); iii) Older adults (\>65 years). Participants will be assigned to either a physical activity intervention group or a control group. The intervention group will follow a 48-week structured program including, muscle-strengthening sessions (bodyweight exercises at home) and aerobic sessions (moderate-intensity cardio exercise). The control group will not receive any exercise prescription. The primary objective is to evaluate whether physical activity improves muscle strength, measured through handgrip strength at 12 and 48 weeks. Secondary objectives include: i) assessing changes in muscle mass, function, and quality of life; ii) measuring improvements in physical performance (aerobic capacity, balance, and mobility tests); iii) evaluating psychological and cognitive well-being. This 48-week trial will consist of: i) baseline assessments (body composition, strength tests, physical and cognitive evaluations); ii) intervention period (12 weeks of structured training for the experimental group); iii) follow-up assessments (at 12 and 48 weeks). All participants will undergo periodic evaluations, including anthropometric and body composition measurements (weight, BMI, muscle mass), aerobic and muscle strength tests (handgrip, knee extension, 1-rep max tests), functional mobility assessments (six-minute walking test, chair-stand test), psychological and cognitive evaluations (mood profiles, quality of life surveys, cognitive tests). Engaging in regular exercise may help participants: i) maintain muscle mass and strength; ii) improve physical function and balance; iii) enhance overall well-being and independence; iv) reduce the risk of age-related disabilities. Additionally, the study aims to provide valuable insights into the role of exercise in healthy aging, helping healthcare providers develop personalized interventions for older adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
This intervention consists of a 48-week structured physical activity program designed to counteract age-related muscle decline. Participants assigned to this group will engage in a home-based exercise program, including muscle-strengthening exercises (bodyweight exercises targeting major muscle groups; progressive difficulty based on individual capacity; designed for feasibility in daily life, requiring no specialized equipment) and aerobic exercise (moderate-intensity cardiovascular activity (e.g., brisk walking, cycling); target heart rate between 65-75% of the estimated maximum heart rate). The program follows guidelines from the American College of Sports Medicine (ACSM) and aims to improve muscle strength, function, and quality of life. It is distinct from other studies as it specifically targets preventing sarcopenia and muscle loss through a practical, home-based, and scalable intervention. Participants will be monitored through periodic assessments.
Università degli Studi di Milano
Milan, Milan, Italy
Change in handgrip strength at 12 and 48 weeks
Handgrip strength will be measured using a hand dynamometer to assess the maximal isometric force of the dominant hand. The mean of three trials will be recorded, with 60-second rest intervals between attempts. An increase in handgrip strength over time will indicate the effectiveness of the physical activity intervention in maintaining or improving muscle function in aging adults.
Time frame: Baseline, Week 12, and Week 48
Change in muscle mass
Body composition, including lean muscle mass, will be assessed using bioelectrical impedance analysis (BIA) to evaluate changes in muscle preservation and hypertrophy.
Time frame: Baseline, Week 12, and Week 48
Change in Lower Limb Strength (Knee Extension Isometric Force, N) at 12 and 48 weeks
Maximal isometric knee extension force will be measured using a dynamometer to assess improvements in lower limb muscle strength.
Time frame: Baseline, Week 12, and Week 48
Change in Physical Performance (Six-Minute Walk Test, meters) at 12 and 48 weeks
Walking endurance will be assessed using the Six-Minute Walk Test (6MWT) following the American Thoracic Society guidelines, measuring the total distance covered in six minutes.
Time frame: Baseline, Week 12, and Week 48
Change in Functional Mobility (Chair Stand Test, repetitions) at 12 and 48 weeks
The 30-second Chair Stand Test will evaluate lower limb strength and endurance by counting the number of times a participant can rise from a chair within 30 seconds.
Time frame: Baseline, Week 12, and Week 48
Change in Balance and Postural Control (Mini-BESTest Score) at 12 and 48 weeks
Balance and postural control will be measured using the Mini Balance Evaluation Systems Test (Mini-BESTest), which assesses postural adjustments, sensory orientation, and gait stability.
Time frame: Baseline, Week 12, and Week 48
Change in Quality of Life (SF-12 Health Survey Score) at 12 and 48 weeks
Quality of life will be assessed using the SF-12 questionnaire, which evaluates both physical and mental health components.
Time frame: Baseline, Week 12, and Week 48
Change in Cognitive Function (Trail Making Test, A & B) at 12 and 48 weeks
Executive function and processing speed will be evaluated using the Trail Making Test (TMT A \& B), where participants connect numbered and lettered sequences as quickly as possible.
Time frame: Baseline, Week 12, and Week 48
Change in Psychological Well-being (Profile of Mood States - POMS) at 12 and 48 weeks
Mood states will be assessed using the Profile of Mood States (POMS) questionnaire, measuring anxiety, fatigue, vigor, depression, and confusion.
Time frame: Baseline, Week 12, and Week 48
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