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NCT Number: NCT07244562

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

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.

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Key information

Conditions

Elderly Older Adults, Aging Brain

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Esercizio Vita

Ferrara, 44124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Behavioral

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 training

Behavioral

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 home

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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).

  3. 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).

  4. 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

  5. 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).

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Pomidori, PhD

CONTACT

[email protected]

00393455984607

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • Università degli Studi di Ferrara

Registry information

Official study title

Effects of Cognitive Training and Exercise on Cognitive Function in Older Women: the INCOGNITO Randomized Clinical Trial

Acronym: INCOGNITO

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 24, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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