Muscle Aging Evaluation

February 19, 2025 updated by: Matteo Bonato, University of Milan

Assessment of Physical and Physiological Changes in Muscle Aging

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Universita degli Studi di Milano
        • Contact:
          • Matteo Bonato, Ph.D., Associate Professor, Ph.D.
          • Phone Number: +39 02503 14641
          • Email: matteo.bonato@unimi.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity group

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.
Other: Physical activity Group

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.

Other Names:
  • Exercise intervention
No Intervention: Control Group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in handgrip strength at 12 and 48 weeks
Time Frame: Baseline, Week 12, and Week 48
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.
Baseline, Week 12, and Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle mass
Time Frame: Baseline, Week 12, and Week 48
Body composition, including lean muscle mass, will be assessed using bioelectrical impedance analysis (BIA) to evaluate changes in muscle preservation and hypertrophy.
Baseline, Week 12, and Week 48
Change in Lower Limb Strength (Knee Extension Isometric Force, N) at 12 and 48 weeks
Time Frame: Baseline, Week 12, and Week 48
Maximal isometric knee extension force will be measured using a dynamometer to assess improvements in lower limb muscle strength.
Baseline, Week 12, and Week 48
Change in Physical Performance (Six-Minute Walk Test, meters) at 12 and 48 weeks
Time Frame: Baseline, Week 12, and Week 48
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.
Baseline, Week 12, and Week 48
Change in Functional Mobility (Chair Stand Test, repetitions) at 12 and 48 weeks
Time Frame: Baseline, Week 12, and Week 48
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.
Baseline, Week 12, and Week 48
Change in Balance and Postural Control (Mini-BESTest Score) at 12 and 48 weeks
Time Frame: Baseline, Week 12, and Week 48
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.
Baseline, Week 12, and Week 48
Change in Quality of Life (SF-12 Health Survey Score) at 12 and 48 weeks
Time Frame: Baseline, Week 12, and Week 48
Quality of life will be assessed using the SF-12 questionnaire, which evaluates both physical and mental health components.
Baseline, Week 12, and Week 48
Change in Cognitive Function (Trail Making Test, A & B) at 12 and 48 weeks
Time Frame: Baseline, Week 12, and Week 48
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.
Baseline, Week 12, and Week 48
Change in Psychological Well-being (Profile of Mood States - POMS) at 12 and 48 weeks
Time Frame: Baseline, Week 12, and Week 48
Mood states will be assessed using the Profile of Mood States (POMS) questionnaire, measuring anxiety, fatigue, vigor, depression, and confusion.
Baseline, Week 12, and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSR2023_BONATO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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