- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494149
Group-Based Exercise Intervention to Prevent Cognitive and Motor Decline
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Inaihá L. Benincá, PhD student
- Phone Number: +39 0352052960
- Email: inaiha.laureanobeninca@unibg.it
Study Locations
-
-
BG
-
Bergamo, BG, Italy, 24124
- Not yet recruiting
- University of Bergamo - S. Agostino
-
Contact:
- Francesca Morganti, Professor
- Phone Number: +39 0352052960
- Email: francesca.morganti@unibg.it
-
-
Bergamo
-
Bergamo, Bergamo, Italy, 24129
- Recruiting
- Centre for Healthy Longevity
-
Contact:
- Francesca Morganti
- Phone Number: 035 2052960
- Email: longevita@unibg.it
-
Principal Investigator:
- Inaihá L Benincá, PhD Student
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
The Ideomotor Program sessions will include the following:
Other Names:
|
|
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.
|
The Group-based cognitive training will include the following:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
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At baseline and at the end of the intervention period (week 17)
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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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024_04_02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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