Muscle Aging Evaluation

University of Milan

Status: Not yet enrolling

Conditions: Preventing Age-Related Muscle Loss: the Role of Exercise in Improving Strength, Function, and Well-being

Treatments: Other: Physical activity Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06845748

PSR2023_BONATO

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18 years and older.
• Must be able to engage in physical activity as prescribed in the study protocol.
• No pre-existing musculoskeletal conditions that would prevent safe participation.
• No history of hospitalization in the six weeks prior to enrollment.
• No acute or uncontrolled medical conditions that could interfere with exercise participation.
• Willing to sign an informed consent form before participation.

Exclusion criteria

• Severe Medical Conditions (cardiovascular diseases, severe respiratory diseases, neurological disorders)
• Cognitive and Psychological Conditions (severe cognitive impairment or dementia, psychiatric disorders)
• Pregnancy
• Use of anabolic or muscle-enhancing substances (use of steroids, testosterone therapy, or other performance-enhancing drugs within the past 6 months)
• Participation in ther Clinical Trials

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Physical activity group

Experimental group

Description:

Participants in this group will follow a structured physical activity program for 48 weeks. The intervention consists of muscle-strengthening sessions (bodyweight exercises at home) and aerobic sessions (moderate-intensity cardio exercise). The program is designed to improve muscle strength, mass, and function, aiming to counteract age-related muscle decline. Participants will undergo periodic assessments to measure physical performance, cognitive function, and quality of life.

Treatment:

Other: Physical activity Group

Control Group

No Intervention group

Description:

Participants in this group will not receive a structured exercise program. They will continue their usual lifestyle without specific physical activity recommendations. The control group will undergo the same periodic assessments as the experimental group to evaluate changes in muscle strength, function, body composition, and overall well-being over the 48-week study period.