ElderlyINCOGNITONCT07244562
Effects of Physical Exercise and Cognitive Training on Quality of Life in Older Women
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Exercise plus cognitive training and Exercise plus cognitive stimulus at home in people with Elderly and Older Adults, Aging Brain, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Ageing exposes people to a progressive loss of cognitive and functional abilities, especially in women. The aim of the study is to investigate the effectiveness of different types of intervention, based on physical exercise and/or cognitive stimulation or training, on quality of life, cognition and mobility, on a… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Elderly, Older Adults, Aging Brain
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Exercise plus cognitive training and Exercise plus cognitive stimulus at home
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age ≥ 60 years
- Provision of the informed consent form
Who cannot join
- Absolute contraindications to physical exercise (e.g. Nyha class iv heart failure, unstable angina, etc.)
- Pregnancy
- Severe cognitive impairment, defined as a MoCa score ≤ 12
- Severe visual impairment or blindness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Cognitive Training and Exercise on Cognitive Function in Older Women: the INCOGNITO Randomized Clinical Trial
Ageing exposes people to a progressive loss of cognitive and functional abilities, especially in women. The aim of the study is to investigate the effectiveness of different types of intervention, based on physical exercise and/or cognitive stimulation or training, on quality of life, cognition and mobility, on a population of older women.
- Conditions
- Elderly, Older Adults, Aging Brain
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Exercise plus cognitive training, Exercise plus cognitive stimulus at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONBehavioural
The exercise program includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching.
Exercise plus cognitive trainingBehavioural
In addition to the exercise program, participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants.
Exercise plus cognitive stimulus at homeBehavioural
In addition to the exercise program, participants will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 - Exercise plus cognitive training | Experimental | In addition to the exercise program, participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants Receives: Behavioral: Exercise plus cognitive training |
| Experimental 2 - Exercise plus cognitive stimulus | Experimental | In addition to the exercise program, people randomised into this group will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options Receives: Behavioral: Exercise plus cognitive stimulus at home |
| Active comparator - Exercise only | Active comparator | The exercise program (equal for all the study groups with the exercise intervention) includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching. Receives: Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
| Control group | No intervention | The subjects included in this group will not receive any specific treatment. They will receive advice on how to stay active at home and will undergo scheduled assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function and processing speed by the Trail Making Test (TMT)
TMT is neuropsychological test that assesses a person's cognitive function, specifically focusing on visual attention, processing speed, and executive function. The test consists of two parts, the score is based on the time it takes to complete each part, with shorter times indicating better performance.
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Secondary outcomes (8)
Quality of life by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire
QOL-AD consists of 13 questions covering various aspects of daily life, such as physical health, energy, mood, relationships and the ability to enjoy enjoyable activities. The combined scores of the patient and caregiver provide a more comprehensive and accurate picture of the person's overall well-being. The scale has a score ranging from 13 (lowest quality of life) to 52 (highest quality of life).
This measure will be collected in people with MCI only
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Quality of life assessed by the short-form 36 (SF-36) questionnaire
This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks. For each specific domain, the score ranges from 0 (lowest quality of life) to 100 (highest quality of life).
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Cognition assessed by the Montreal Cognitive Assessment (MoCA)
MoCA is a 30-point test evaluates cognitive function. Its primary purpose is to detect mild cognitive impairment (MCI). The score goes from 0 (maximal cognitive deficit) to 30 (normal cognitive function).
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Walking endurance assessed by the 6-Minute Walking Test (6MWT)
The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Physical performance assessed using the Short Physical Performance Battery (SPPB)
It is a specific assessment for the elderly population, consisting of three functional tests that measure postural stability, the ability to walk safely, and lower limb muscle strength. The scale goes from 0 (lowest functional ability) to 12 (highest functional ability).
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Manual grip strength using the Handgrip Test (HT).
The test is performed using a dynamometer: the subject grabs the handle of the device with maximum strength, and the maximum value of force expressed in kilograms is recorded.
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Sleep quality and related disorders through the Pittsburgh Sleep Quality Index (PSQI)
It refers to the last 30 days and analyses seven components. The total score ranges from 0 to 21. A score above 5 indicates poor sleep quality.
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Frontal and prefrontal cerebral perfusion using near-infrared spectroscopy (fNIRS).
Changes in brain metabolism will be assessed using NIRS with a system consisting of 16 sources and 16 detectors emitting two wavelengths of light in the near infrared range. Recording using the non-invasive fNIRS method will take place during the TMT.
Measured: Baseline; end of the program (3-month); Follow-up (6-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Responsible party
- Principal investigator, Fabio Manfredini, University Hospital of Ferrara
- Investigators
- Fabio Manfredini, MD, PhD, Study chair, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244562
- Sponsor's protocol ID
- 417/2025/Sper/UniFe
- Acronym
- INCOGNITO
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Training and Exercise on Cognitive Function in Older Women: the INCOGNITO Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07244562
- Acronym / sponsor ID
- INCOGNITO / 417/2025/Sper/UniFe
- Conditions
- Elderly, Older Adults, Aging Brain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ageing exposes people to a progressive loss of cognitive and functional abilities, especially in women. The aim of the study is to investigate the effectiveness of different types of intervention, based on physical exercise and/or cognitive stimulation or training, on quality of life, cognition and mobility, on a population of older women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 - Exercise plus cognitive training | Experimental | Behavioral: Exercise plus cognitive trainingIn addition to the exercise program, participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants |
| Experimental 2 - Exercise plus cognitive stimulus | Experimental | Behavioral: Exercise plus cognitive stimulus at homeIn addition to the exercise program, people randomised into this group will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options |
| Active comparator - Exercise only | Active comparator | Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONThe exercise program (equal for all the study groups with the exercise intervention) includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching. |
| Control group | No intervention | –The subjects included in this group will not receive any specific treatment. They will receive advice on how to stay active at home and will undergo scheduled assessments. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Age ≥ 60 years
- Provision of the informed consent form
Key exclusion criteria (4 listed)
- Absolute contraindications to physical exercise (e.g. Nyha class iv heart failure, unstable angina, etc.)
- Pregnancy
- Severe cognitive impairment, defined as a MoCa score ≤ 12
- Severe visual impairment or blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONThe exercise program includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching. | Behavioural | Active comparator - Exercise only |
| Exercise plus cognitive trainingIn addition to the exercise program, participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants. | Behavioural | Experimental 1 - Exercise plus cognitive training |
| Exercise plus cognitive stimulus at homeIn addition to the exercise program, participants will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options. | Behavioural | Experimental 2 - Exercise plus cognitive stimulus |
Primary outcome
Executive function and processing speed by the Trail Making Test (TMT)
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
TMT is neuropsychological test that assesses a person's cognitive function, specifically focusing on visual attention, processing speed, and executive function. The test consists of two parts, the score is based on the time it takes to complete each part, with shorter times indicating better performance.
8 secondary outcomes
Quality of life by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
Quality of life assessed by the short-form 36 (SF-36) questionnaire
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
Cognition assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
Walking endurance assessed by the 6-Minute Walking Test (6MWT)
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
Physical performance assessed using the Short Physical Performance Battery (SPPB)
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
Manual grip strength using the Handgrip Test (HT).
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
Sleep quality and related disorders through the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
Frontal and prefrontal cerebral perfusion using near-infrared spectroscopy (fNIRS).
Time frame: Baseline; end of the program (3-month); Follow-up (6-month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Manfredini, MD, PhD study chair
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Exercise plus cognitive training and Exercise plus cognitive stimulus at home in people with Elderly and Older Adults, Aging Brain, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Pomidori, PhD (00393455984607, info@eserciziovita.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive function and processing speed by the Trail Making Test (TMT) (time frame: Baseline; end of the program (3-month); Follow-up (6-month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.