Group-Based Exercise Intervention to Prevent Cognitive and Motor Decline
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Bergamo
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 50 years old;
Able to move independently;
Live in the community;
Demonstrated ability to comprehend complex verbal instructions.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ideomotor
Other interventionThe 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.
Control
Other interventionThe 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.
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: Ideomotor Group Exercise ProgramExperimental treatment 1 intervention
Group B: Cognitive training programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
At baseline and at the end of the intervention period (week 17)2
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)
Time frame
At baseline and at the end of the intervention period (week 17)3
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)
Time frame
At baseline and at the end of the intervention period (week 17)4
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)
Time frame
At baseline and at the end of the intervention period (week 17)Secondary outcomes
1
Movement Quality
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
Time frame
At baseline and at the end of the intervention period (week 17)2
Balance
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)
Time frame
At baseline and at the end of the intervention period (week 17)3
Endurance
The 2-minute Step Test will be used to assess changes from baseline in aerobic capacity
Time frame
At baseline and at the end of the intervention period (week 17)4
Lower limb strength and power
The 30s Sit to Stand will be used to assess changes from baseline in lower limb strength and power
Time frame
At baseline and at the end of the intervention period (week 17)Other outcomes
1
Quality of life
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)
Time frame
At baseline and at the end of the intervention period (week 17)2
Depression symptoms
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)
Time frame
At baseline and at the end of the intervention period (week 17)3
Anxiety symptoms
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)
Time frame
At baseline and at the end of the intervention period (week 17)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Bergamo
Lead sponsor
CUS - Sports Centre of the University of Bergamo
Collaborator
ACLI provinciali di Bergamo
Collaborator
Source ClinicalTrials.gov