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NCT Number: NCT07494149

Group-Based Exercise Intervention to Prevent Cognitive and Motor Decline

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.

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Key information

Conditions

Healthy Behavior Motor Activity Older Adults Personal Satisfaction Psychological Well-Being

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergamo - S. Agostino, Bergamo, BG, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ideomotor

Other

The Ideomotor Program sessions will include the following:

  • Warm-up Light-intensity physical-cognitive exercises.
  • Work-out 1 Mind-Motor:

Stimulates physical and cognitive abilities through functional exercises.

  • 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).
  • Cool-down: light-intensity walking or dynamic stretching combined with breathing
  • Socialization: dedicated moment to encourage socialization. Participants' feedback will be received once a month.

Other names: Ideomotor Group Exercise Program

Control

Other

The Group-based cognitive training will include the following:

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

Other names: Group-based cognitive training

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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)

  2. 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)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Inaihá L. Benincá, PhD student

CONTACT

[email protected]

+39 0352052960

Sponsors and collaborators

Lead sponsor

University of Bergamo

Other

Collaborators

  • ACLI provinciali di Bergamo
  • CUS - Sports Centre of the University of Bergamo

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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