Group-Based Exercise Intervention to Prevent Cognitive and Motor Decline

NCT07494149 | Recruiting

• 1 other identifier: 2024_04_02
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy; Older Adults

Keywords

Exercise; Cognition; Psychological Well-Being; Primary Prevention; Physical Fitness; healthy longevity

Outcome Measures

Primary Outcomes (4)

• Executive functions

  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

  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

  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

  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 Outcomes (5)

• Movement Quality

  At baseline and at the end of the intervention period (week 17)

• Balance

  At baseline and at the end of the intervention period (week 17)

• Endurance

  At baseline and at the end of the intervention period (week 17)

• Lower limb strength and power

  At baseline and at the end of the intervention period (week 17)

• Hand grip strength

  At baseline and at the end of the intervention period (week 17)

Other Outcomes (3)

• Quality of life

  At baseline and at the end of the intervention period (week 17)

• Depression symptoms

  At baseline and at the end of the intervention period (week 17)

• Anxiety symptoms

  At baseline and at the end of the intervention period (week 17)

Study Arms (2)

Ideomotor Group Exercise Program

EXPERIMENTAL

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

Cognitive training program

ACTIVE COMPARATOR

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

Interventions

Ideomotor OTHER

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.

Also known as: Ideomotor Group Exercise Program

Ideomotor Group Exercise Program

Control OTHER

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.

Also known as: Group-based cognitive training

Cognitive training program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Centre for Healthy Longevity

Bergamo, Bergamo, 24129, Italy

RECRUITING

University of Bergamo - S. Agostino

Bergamo, BG, 24124, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Central Study Contacts

Inaihá L. Benincá, PhD student

CONTACT

+39 0352052960; inaiha.laureanobeninca@unibg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researcher responsible for data analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)