Muscle Aging Evaluation

Official title

Assessment of Physical and Physiological Changes in Muscle Aging

Overview

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.

Interventions

• 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

Primary outcome measures

• Change in handgrip strength at 12 and 48 weeks [Time frame: Baseline, Week 12, and Week 48]

Secondary outcome measures (8)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Italy · 1 center

• Università degli Studi di Milano — Milan

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. PMID 30124583
• Balsalobre-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. PMID 25555023
• ATS 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. PMID 12091180
• Seo 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. PMID 24149193
• Lohman TG. Skinfolds and body density and their relation to body fatness: a review. Hum Biol. 1981 May;53(2):181-225. No abstract available. PMID 7239496
• Bisio 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. PMID 29037155

Identifiers

NCT: NCT06845748 · PSR2023_BONATO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗