Group-Based Exercise Intervention to Prevent Cognitive and Motor Decline

March 19, 2026 updated by: Francesca Morganti, University of Bergamo

Effects of the Ideomotor Group Program Exercise on Cognitive Functioning, Motor Functioning and Overall Well-being in Community-Dwelling Older Adults

The goal of this clinical trial is to evaluate the efficacy of the Ideomotor Program in healthy older adults living in the community. The main research questions are:

1) Is the Ideomotor Program effective in improving cognitive function? 2) Is the Ideomotor Program effective in improving motor function? 3) Is the Ideomotor Program effective in improving overall well-being?

Researchers will compare the Ideomotor Program to a community group cognitive training program to determine whether the effects are superior. Participants will: undergo assessments at baseline, at the mid-intervention point, and upon program completion; participate in a 16-week group exercise program in a community gym two times per week; keep a diary to monitor the number of falls and any adverse events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • BG
      • Bergamo, BG, Italy, 24124
        • Not yet recruiting
        • University of Bergamo - S. Agostino
        • Contact:
    • Bergamo
      • Bergamo, Bergamo, Italy, 24129
        • Recruiting
        • Centre for Healthy Longevity
        • Contact:
        • Principal Investigator:
          • Inaihá L Benincá, PhD Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • At least 50 years old;
  • Able to move independently;
  • Live in the community;
  • Demonstrated ability to comprehend complex verbal instructions.

Exclusion Criteria:

  • Presence of severe neurological and psychological conditions;
  • Less than 9,36 score in the FAB15;
  • Lack of medical clearance to participate in an exercise program;
  • Less than 75% of attendance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ideomotor Group Exercise Program
The intervention group will follow the Ideomotor Program, attending group sessions with a maximum of 12 participants over a period of 16 weeks. The protocol is structured into two weekly sessions, each lasting 60 minutes. The workout combines physical and cognitive exercises using a mind-motor training approach, incorporating aerobic and functional activities, except for one quarter of the weekly training, which consists of high-velocity muscle power exercises performed without a cognitive component.
Other: Ideomotor

The Ideomotor Program sessions will include the following:

  1. Warm-up Light-intensity physical-cognitive exercises.

  2. Work-out 1 Mind-Motor:

    Stimulates physical and cognitive abilities through functional exercises.

  3. Work-out 2 3.1) Mind-Motor: stimulate physical and cognitive abilities through aerobic exercises (once a week) 3.2) Work-out 2 Motor only: high-velocity muscle power exercises (once a week).
  4. Cool-down: light-intensity walking or dynamic stretching combined with breathing
  5. Socialization: dedicated moment to encourage socialization. Participants' feedback will be received once a month.
Other Names:
  • Ideomotor Group Exercise Program
Active Comparator: Cognitive training program
The control group will participate in a group-based cognitive training program without a motor component. This training matches the experimental group in terms of cognitive training dose, session duration, and number of participants. The program is based on cognitive exercises considered the gold standard for cognitive training.
Other: Control

The Group-based cognitive training will include the following:

  1. Warm-up: cognitive exercises designed for training basic cognitive abilities in adults and older adults;
  2. Work-out: cognitive exercises designed for training complex cognitive abilities in adults and older adults;
  3. Cool-down: moment for discussion of the exercises and their possible solutions;
  4. Socialization: dedicated moment to encourage socialization. Participants' feedback will be received once a month.
Other Names:
  • Group-based cognitive training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Executive functions
Time Frame: At baseline and at the end of the intervention period (week 17)
The Frontal Assessment Battery-15 will be used to access changes from baseline in executive functions (score range: 0-15, higher scores mean a better outcome)
At baseline and at the end of the intervention period (week 17)
Cognitive flexibility
Time Frame: At baseline and at the end of the intervention period (week 17)
Wisconsin Card Sorting Test will be used to assess changes from baseline in cognitive flexibility (score range perseverative errors: 0-64, higher scores mean a worse outcome)
At baseline and at the end of the intervention period (week 17)
Short-term and working memory
Time Frame: At baseline and at the end of the intervention period (week 17)
The Digit span test (forward and backward) will be used to assess from baseline changes in short-term and working memory (foward score range: 3-9, backward score range: 3-8; higher scores mean a better outcome)
At baseline and at the end of the intervention period (week 17)
Visuo-spatial short term working memory
Time Frame: At baseline and at the end of the intervention period (week 17)
The Corsi Block-Tapping Test will be used to assess changes from baseline in visuo-spatial short term working memory (score range: 2-9, higher scores mean a better outcome)
At baseline and at the end of the intervention period (week 17)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Movement Quality
Time Frame: At baseline and at the end of the intervention period (week 17)
Instrumented motion analysis will be conducted through the usage of inertial sensors to assess changes from baseline in spatiotemporal and kinematics parameters during walking, turning and stepping tasks
At baseline and at the end of the intervention period (week 17)
Balance
Time Frame: At baseline and at the end of the intervention period (week 17)
The Mini-BESTest: Balance Evaluation Systems Test will be used to measure changes from baseline in balance (score range: 0-28, higher scores mean a better outcome)
At baseline and at the end of the intervention period (week 17)
Endurance
Time Frame: At baseline and at the end of the intervention period (week 17)
The 2-minute Step Test will be used to assess changes from baseline in aerobic capacity
At baseline and at the end of the intervention period (week 17)
Lower limb strength and power
Time Frame: At baseline and at the end of the intervention period (week 17)
The 30s Sit to Stand will be used to assess changes from baseline in lower limb strength and power
At baseline and at the end of the intervention period (week 17)
Hand grip strength
Time Frame: At baseline and at the end of the intervention period (week 17)
The Hand Grip strength Test will be used to assess changes from baseline in hand grip strength
At baseline and at the end of the intervention period (week 17)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: At baseline and at the end of the intervention period (week 17)
The WHOQOL-BREF will be used to assess changes from baseline in quality of life (score range: 4-20 for each domain, higher scores mean a better outcome)
At baseline and at the end of the intervention period (week 17)
Depression symptoms
Time Frame: At baseline and at the end of the intervention period (week 17)
The Geriatric Depression Scale will be used to assess changes from baseline in depressive symptoms (score range: 0-15, higher scores mean a worse outcome)
At baseline and at the end of the intervention period (week 17)
Anxiety symptoms
Time Frame: At baseline and at the end of the intervention period (week 17)
The State-Trait Anxiety Inventory will be used to assess changes in anxiety symptoms from baseline (score range: 0-20, higher scores mean a worse outcome)
At baseline and at the end of the intervention period (week 17)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bergamo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CUS - Sports Centre of the University of Bergamo
ACLI provinciali di Bergamo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024_04_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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