Effects of Physical Exercise and Cognitive Training on Quality of Life in Older Women (INCOGNITO)

December 4, 2025 updated by: Fabio Manfredini, University Hospital of Ferrara

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ferrara, Italy, 44124
        • Esercizio Vita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female
  • Age ≥ 60 years
  • Provision of the informed consent form

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1 - Exercise plus cognitive training
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
Behavioral: Exercise plus cognitive training
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.
Experimental: Experimental 2 - Exercise plus cognitive stimulus
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
Behavioral: Exercise plus cognitive stimulus at home
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.
Active Comparator: Active comparator - Exercise only
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.
Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
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.
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline; end of the program (3-month); Follow-up (6-month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking endurance assessed by the 6-Minute Walking Test (6MWT)
Time Frame: Baseline; end of the program (3-month); Follow-up (6-month)
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
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)
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.
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)
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.
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)
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.
Baseline; end of the program (3-month); Follow-up (6-month)
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)

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
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)
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).
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)
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).
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)
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).
Baseline; end of the program (3-month); Follow-up (6-month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Collaborators

Università degli Studi di Ferrara

Investigators

  • Study Chair: Fabio Manfredini, MD, PhD, Università degli Studi di Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Estimated)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 417/2025/Sper/UniFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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