Fine-tuned Physical Training to Improve Quality of Life in Older Individuals

NCT07546734 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-29

No results posted yet for this study

Summary

The overall aim of this project, which is based upon the interdisciplinary expertise of four research groups within the University of Rome Foro Italico, in the macro-areas of psychology, bioengineering, physiology, and internal medicine, is to improve the overall health and well-being of community-dwelling frail older adults, who are often suffering from non-communicable diseases, by means of an integration of innovative cognitive and resistance-core training. Forty-five frail or pre-frail community-dwelling older adults aged ≥65 years will be randomly assigned to three 8-week intervention groups: A) resistance training; B) resistance-core training; C) cognitive-resistance-core training. Comparison between groups C and B will show the effects of an innovative cognitive-motor dual-task training method, which will incorporate principles of modern psychotherapeutic approaches to boost physical training, and to improve cognitive, emotional, and mood disturbances in older ages.

Comparison between groups B and A will focus on the motor component of the intervention, showing the effects of adding specific core-exercises to a traditional resistance training program on muscle strength, power, and the ability to safely carry out functional abilities of daily life.

As outcomes, clinical and psychological scales, cognitive tasks, and their underlying cortical mechanisms will be measured. In addition, state-of-art physiological and biomechanical methods will be used to study human kinematics, muscle synergies, and cortico-muscular coherence furthering some important neurophysiological mechanisms of motor control underlying the execution of functional tasks.

The results of this project, therefore, will be of great relevance for the advancement of training-exercise methodology as well as unravelling central and peripheral mechanisms underlying frailty with the final goal of improving the quality of life in older individuals.

Conditions

  • Frail Elderly
  • Elderly
  • Aging
  • Aging Frailty
  • Sarcopenia in Elderly

Interventions

OTHER

Resistance Training (RT)

Basic routine of resistance training based on multi-articular and mono-articular exercises, such as leg press, shoulder press, leg extension, leg curl, biceps curl, triceps pushdown, calf raises.

OTHER

Resistance training + CORE (RT+CORE)

This core-focused motor training followed a motor program emphasizing trunk stability and postural control. Exercises targeted core muscle activation, postural alignment, and coordination during standing and walking tasks, while maintaining the same overall level of physical effort and safety constraints as the general motor training group.

OTHER

CMDT training

Cognitive-Motor Dual-Task Training (CMDT) program in which physical exercises were systematically combined with concurrent cognitive demands. The CMDT protocol was designed to simultaneously engage motor performance, executive functions, and attentional control, thereby enhancing the integration of cognitive and motor processes.

Sponsors & Collaborators

  • University of Rome Foro Italico

    lead OTHER

Principal Investigators

  • Francesco Di Russo, PhD · University of Rome 'Foro Italico'

  • Chiara Fossati, MD, PhD · University of Rome 'Foro Italico'

  • Andrea Macaluso, MD, PhD · University of Rome 'Foro Italico'

  • Arnaldo Zelli, PhD · University of Rome 'Foro Italico'

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-12
Primary Completion
2026-04-30
Completion
2026-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546734 on ClinicalTrials.gov