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

Combining Principles of Psychological Sciences and Fine-tuned Physical Training to Improve Quality of Life in Frail Older Individuals: a Psychological, Neurocognitive, Neuromechanical, and Clinical Perspective

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aging; Elderly; Frail Elderly; Aging Frailty; Sarcopenia in Elderly
• Intervention / Treatment: Other: Resistance Training (RT); Other: Resistance training + CORE (RT+CORE); Other: CMDT training

Detailed Description

The study sought to exploit a method known as Bilateral Alternating Stimulation (BAS), which was introduced within the framework of Eye Movement Desensitisation and Reprocessing (EMDR) psychotherapy as a central component of a protocol designed to facilitate the processing of traumatic memories. Subsequently, this procedure was incorporated into the Adaptive Information Processing (AIP) model, according to which bilateral stimulation promotes the integration of dysfunctional information within adaptive memory networks. Various theoretical interpretations have been proposed to explain the underlying mechanisms, including the model of interhemispheric interaction, which suggests an enhancement of communication between the cerebral hemispheres (Christman et al., 2003). Furthermore, alternating bilateral stimulation modulates interhemispheric coherence, suggesting a reorganisation of communication processes between hemispheres that could facilitate the integration of cognitive and emotional information. It also modulates prefrontal cortex activity and fronto-limbic connectivity, suggesting a reorganisation of cognitive and emotional control processes. More recent electroencephalographic (EEG) evidence confirms the involvement of frontal areas, in line with theoretical models that attribute these effects to the modulation of attentional and executive systems.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome
    • Rome, Rome, Italy, 00135
      • University of Rome 'Foro Italico'

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pre-frail/frail community-dwelling older adults
• Aged ≥65 years
• Community-dwelling

Exclusion Criteria:

• Cognitive decline (mini-mental state examination <25/30)
• Neurological disorders
• Conditions impairing the ability to carry out exercise training (e.g., Parkinson's disease; multiple sclerosis; stroke)
• Depression treated with pharmacological therapy or that have incurred in falls in the last two years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 (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.
Experimental: Resistance training + CORE (RT+CORE)	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.
Experimental: Resistance training + CORE + EMDR (RT+CORE+EMDR)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety levels	Anxiety levels were assessed using the State-Trait Anxiety Inventory, Form Y (STAI). The STAI is widely considered a standard instrument for the assessment of anxiety and consists of two self-report subscales designed to measure state anxiety and trait anxiety. State anxiety (STAI-Y1) refers to a transient emotional condition characterized by feelings of tension, apprehension, and heightened autonomic activity. In contrast, trait anxiety (STAI-Y2) reflects a relatively stable personality disposition associated with a tendency to perceive situations as threatening and to respond with persistent worry, agitation, and nervousness. Total scores for each subscale range from 20 to 80, with commonly adopted interpretative thresholds indicating low or absent anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80).	At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)
Depression level	Depression levels were assessed using the Beck Depression Inventory-II (BDI-II), which is a self-report instrument used to assess the severity of depressive symptoms in adolescents and adults. The questionnaire consists of 21 items that investigate cognitive, affective, and somatic symptoms of depression. Each item is rated on a scale of 0 to 3, with reference to the last two weeks. The total score, obtained from the sum of the responses (range 0-63), reflects the severity of depressive symptoms. According to standard interpretative guidelines, scores are classified as no or minimal (0-13) depression, mild (14-19), moderate (20-28), and severe (29-63) depression. Participants completed the questionnaires independently.	At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)
Cognitive test during EEG recording	A visuomotor discrimination response task (DRT), based on a Go/No-go paradigm, was included to assess executive control processes involved in task anticipation, including both cognitive and motor preparation, which are known to be particularly sensitive to aging and to cognitive-motor training effects. This task is particularly well-suited for electrophysiological investigation, as it reliably elicits pre-stimulus anticipatory ERP components, such as the Bereitschaftspotential (BP) and the prefrontal negativity (pN). These components index motor preparation and top-down cognitive control, respectively, allowing the assessment of predictive brain activity preceding action execution. For this reason, during the DRT, high-density EEG was also recorded.	At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	Balance was assessed using the Berg Balance Scale (BBS), which is a standardized clinical tool used to assess static and dynamic balance in older adults. It consists of 14 functional tasks representative of everyday activities; each is scored on a 5-point scale (0-4). Total scores range from 0 to 56, with higher scores indicating better balance and lower fall risk (41-56: low fall risk, 21-40: medium fall risk, 0-20: high fall risk). The BBS is widely used in clinical and research settings due to its high reliability and validity in aging populations. The BBS was administered according to standardized procedures by trained evaluators.	At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)

Collaborators and Investigators

• Sponsor: University of Rome Foro Italico
• Investigators: Study Chair: Francesco Di Russo, PhD, University of Rome 'Foro Italico'; Principal Investigator: Chiara Fossati, MD, PhD, University of Rome 'Foro Italico'; Principal Investigator: Andrea Macaluso, MD, PhD, University of Rome 'Foro Italico'; Principal Investigator: Arnaldo Zelli, PhD, University of Rome 'Foro Italico'

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 17, 2025
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Functional mobility; Resistance training; Cognitive training; Dual-task training; Cognitive functions; Event-Related Potentials (ERP); Core-stability training; High-resolution EEG; Muscle synergy analysis; Cortico-muscular coherence
• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: Ricerca_di_Ateneo_DM737Elderly

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