Frail ElderlyNCT07546734
Fine-tuned Physical Training to Improve Quality of Life in Older Individuals
A study testing Resistance Training (RT), Resistance training + CORE (RT+CORE) and CMDT training in people with Frail Elderly and Elderly, run by University of Rome Foro Italico at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly, Elderly, Aging
- What is being tested?
- Resistance Training (RT), Resistance training + CORE (RT+CORE) and CMDT training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2024to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Pre-frail/frail community-dwelling older adults
- Aged ≥65 years
- Community-dwelling
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Frail Elderly, Elderly, Aging, Aging Frailty, Sarcopenia in Elderly
- Being tested
- Resistance Training (RT), Resistance training + CORE (RT+CORE), CMDT training
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 + 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.
CMDT trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Resistance Training (RT) |
| Resistance training + CORE (RT+CORE) | Experimental | Not described Receives: Other: Resistance training + CORE (RT+CORE) |
| Resistance training + CORE + EMDR (RT+CORE+EMDR) | Experimental | Not described Receives: Other: CMDT training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)
Secondary outcomes (1)
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.
Measured: At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start12 Apr 2024
- Primary completion20 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Foro Italico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Di Russo, PhD, Study chair, University of Rome 'Foro Italico'Chiara Fossati, MD, PhD, Principal investigator, University of Rome 'Foro Italico'Andrea Macaluso, MD, PhD, Principal investigator, University of Rome 'Foro Italico'Arnaldo Zelli, PhD, Principal investigator, University of Rome 'Foro Italico'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546734
- Sponsor's protocol ID
- Ricerca_di_Ateneo_DM737Elderly
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07546734
- Acronym / sponsor ID
- Ricerca_di_Ateneo_DM737Elderly
- Conditions
- Frail Elderly, Elderly, Aging, Aging Frailty, Sarcopenia in Elderly
- Keywords
- Dual-task training, Resistance training, Core-stability training, Cognitive training, Functional mobility, Cognitive functions, Quality of life, High-resolution EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Rome Foro ItalicoUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 23 Apr 2026 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training (RT) | Active comparator | 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. |
| Resistance training + CORE (RT+CORE) | Experimental | Other: Resistance training + CORE (RT+CORE) |
| Resistance training + CORE + EMDR (RT+CORE+EMDR) | Experimental | Other: CMDT training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Pre-frail/frail community-dwelling older adults
- Aged ≥65 years
- Community-dwelling
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 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) |
| 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 | Resistance training + CORE (RT+CORE) |
| CMDT trainingCognitive-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. | Other | Resistance training + CORE + EMDR (RT+CORE+EMDR) |
Primary outcome
Anxiety levels
Time frame: At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)
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).
Depression level
Time frame: At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)
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.
Cognitive test during EEG recording
Time frame: At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)
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.
1 secondary outcome
Balance
Time frame: At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Francesco Di Russo, PhD study chair
University of Rome 'Foro Italico'
Chiara Fossati, MD, PhD principal investigator
University of Rome 'Foro Italico'
Andrea Macaluso, MD, PhD principal investigator
University of Rome 'Foro Italico'
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training (RT), Resistance training + CORE (RT+CORE) and CMDT training in people with Frail Elderly and Elderly, run by University of Rome Foro Italico 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety levels (time frame: At T0 (enrollment), T1 (4 weeks), T1 (8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.