Preventing Age-Related Muscle Loss: the Role of Exercise in Improving Strength, Function, and Well-beingNCT06845748
Muscle Aging Evaluation
A study testing Physical activity Group in people with Preventing Age-Related Muscle Loss: the Role of Exercise in Improving Strength, Function, and Well-being, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preventing Age-Related Muscle Loss: the Role of Exercise in Improving Strength, Function, and Well-being
- What is being tested?
- Physical activity Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Università degli Studi di Milano
Milan, Milan, 20133
Matteo Bonato, Ph.D., Associate Professor, Ph.D., +39 02503 14641, matteo.bonato@unimi.it
About this study
Official title: 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).
Read more
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.
- Being tested
- Physical activity Group
- Keywords
- sarcopenia, aging, Frailty prevention, Exercise, interventional study
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity GroupOther
Also called Exercise intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity group | Experimental | 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. Receives: Other: Physical activity Group |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12, and Week 48
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Preventing Age-Related Muscle Loss: the Role of Exercise in Improving Strength, Function, and Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Bonato, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845748
- Sponsor's protocol ID
- PSR2023_BONATO
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jaeger J. Digit Symbol Substitution Test: The Case for Sensitivity Over Specificity in Neuropsychological Testing. J Clin Psychopharmacol. 2018 Oct;38(5):513-519. doi: 10.1097/JCP.0000000000000941.
PubMed 30124583Balsalobre-Fernandez C, Glaister M, Lockey RA. The validity and reliability of an iPhone app for measuring vertical jump performance. J Sports Sci. 2015;33(15):1574-9. doi: 10.1080/02640414.2014.996184. Epub 2015 Jan 2.
PubMed 25555023ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Seo DI, Kim E, Fahs CA, Rossow L, Young K, Ferguson SL, Thiebaud R, Sherk VD, Loenneke JP, Kim D, Lee MK, Choi KH, Bemben DA, Bemben MG, So WY. Reliability of the one-repetition maximum test based on muscle group and gender. J Sports Sci Med. 2012 Jun 1;11(2):221-5. eCollection 2012.
PubMed 24149193Lohman TG. Skinfolds and body density and their relation to body fatness: a review. Hum Biol. 1981 May;53(2):181-225. No abstract available.
PubMed 7239496Bisio A., Bove M. (2018) Cognitive Strategies to Enhance Motor Performance: Examples of Applying Action Observation, Motor Imagery and Psyching-up Techniques. Chapter 12 (pp. 248-281) of Handbook of Sport Neuroscience and Psychophysiology. Ed. Routledge.
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.
PubMed 29037155
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical and Physiological Changes in Muscle Aging
- ClinicalTrials.gov ID
- NCT06845748
- Acronym / sponsor ID
- PSR2023_BONATO
- Keywords
- sarcopenia, aging, Frailty prevention, Exercise, interventional study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity group | Experimental | Other: Physical activity GroupParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity GroupAlso: Exercise interventionThis 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 | Physical activity group |
Primary outcome
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.
8 secondary outcomes
Change in muscle mass
Time frame: 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
Change in Physical Performance (Six-Minute Walk Test, meters) at 12 and 48 weeks
Time frame: 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
Change in Balance and Postural Control (Mini-BESTest Score) at 12 and 48 weeks
Time frame: 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
Change in Cognitive Function (Trail Making Test, A & B) at 12 and 48 weeks
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 30124583Jaeger J. Digit Symbol Substitution Test: The Case for Sensitivity Over Specificity in Neuropsychological Testing. J Clin Psychopharmacol. 2018 Oct;38(5):513-519. doi: 10.1097/JCP.0000000000000941.
- Background: PubMed 25555023Balsalobre-Fernandez C, Glaister M, Lockey RA. The validity and reliability of an iPhone app for measuring vertical jump performance. J Sports Sci. 2015;33(15):1574-9. doi: 10.1080/02640414.2014.996184. Epub 2015 Jan 2.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 24149193Seo DI, Kim E, Fahs CA, Rossow L, Young K, Ferguson SL, Thiebaud R, Sherk VD, Loenneke JP, Kim D, Lee MK, Choi KH, Bemben DA, Bemben MG, So WY. Reliability of the one-repetition maximum test based on muscle group and gender. J Sports Sci Med. 2012 Jun 1;11(2):221-5. eCollection 2012.
- Background: PubMed 7239496Lohman TG. Skinfolds and body density and their relation to body fatness: a review. Hum Biol. 1981 May;53(2):181-225. No abstract available.
- BackgroundBisio A., Bove M. (2018) Cognitive Strategies to Enhance Motor Performance: Examples of Applying Action Observation, Motor Imagery and Psyching-up Techniques. Chapter 12 (pp. 248-281) of Handbook of Sport Neuroscience and Psychophysiology. Ed. Routledge.
- Background: PubMed 29037155Sousa-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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity Group in people with Preventing Age-Related Muscle Loss: the Role of Exercise in Improving Strength, Function, and Well-being, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Bonato, Ph.D., Associate Professor (+39 02503 14641, matteo.bonato@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in handgrip strength at 12 and 48 weeks (time frame: Baseline, Week 12, and Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06845748, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.