Clinical trial NCT06845748: Muscle Aging Evaluation
Official title: Assessment of Physical and Physiological Changes in Muscle Aging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preventing Age-Related Muscle Loss: the Role of Exercise in Improving Strength, Function, and Well-being
Keywords: sarcopenia
aging
Frailty prevention
Exercise
interventional study
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in handgrip strength at 12 and 48 weeks
timeFrame: Baseline, Week 12, and Week 48
Secondary outcomes:
measure: Change in muscle mass
timeFrame: Baseline, Week 12, and Week 48
measure: Change in Lower Limb Strength (Knee Extension Isometric Force, N) at 12 and 48 weeks
timeFrame: Baseline, Week 12, and Week 48
measure: Change in Physical Performance (Six-Minute Walk Test, meters) at 12 and 48 weeks
timeFrame: Baseline, Week 12, and Week 48
measure: Change in Functional Mobility (Chair Stand Test, repetitions) at 12 and 48 weeks
timeFrame: Baseline, Week 12, and Week 48
measure: Change in Balance and Postural Control (Mini-BESTest Score) at 12 and 48 weeks
timeFrame: Baseline, Week 12, and Week 48
measure: Change in Quality of Life (SF-12 Health Survey Score) at 12 and 48 weeks
timeFrame: Baseline, Week 12, and Week 48
measure: Change in Cognitive Function (Trail Making Test, A & B) at 12 and 48 weeks
timeFrame: Baseline, Week 12, and Week 48
measure: Change in Psychological Well-being (Profile of Mood States - POMS) at 12 and 48 weeks
timeFrame: Baseline, Week 12, and Week 48
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Università degli Studi di Milano
Study officials:
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citation: Sousa-Santos AR, Amaral TF. Differences in handgrip strength protocols to identify sarcopenia and frailty - a systematic review. BMC Geriatr. 2017 Oct 16;17(1):238. doi: 10.1186/s12877-017-0625-y.