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

NCT07546734 | Enrolling By Invitation

• 1 other identifier: Ricerca_di_Ateneo_DM737Elderly
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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; Aging; Aging Frailty; Sarcopenia in Elderly; Elderly

Keywords

Dual-task training; Resistance training; Core-stability training; Cognitive training; Functional mobility; Cognitive functions; Quality of life; High-resolution EEG; Event-Related Potentials (ERP); Muscle synergy analysis; Cortico-muscular coherence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Balance

  At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)

Study Arms (3)

Resistance Training (RT)

ACTIVE COMPARATOR

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)

Resistance training + CORE (RT+CORE)

EXPERIMENTAL

Other: Resistance training + CORE (RT+CORE)

Resistance training + CORE + EMDR (RT+CORE+EMDR)

EXPERIMENTAL

Other: CMDT training

Interventions

Resistance Training (RT) OTHER

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.

Resistance Training (RT)

Resistance training + CORE (RT+CORE) OTHER

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.

Resistance training + CORE (RT+CORE)

CMDT training OTHER

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.

Resistance training + CORE + EMDR (RT+CORE+EMDR)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rome Foro Italico: lead

Study Sites (1)

University of Rome 'Foro Italico'

Rome, Rome, 00135, Italy

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Francesco Di Russo, PhD

  University of Rome 'Foro Italico'

  STUDY CHAIR

• 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'

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: this is a 3-arm study but the two motor-only interventions could bemerged into a single control group. This is justified by their functional equivalence and by the need to optimize statistical power and interpretability when comparing cognitive-motor training with motor-only exercise.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: April 23, 2026
• Study Start: April 12, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

IT (1)