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Not yet recruiting NCT07244562

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

No phase Interventional Elderly Older Adults, Aging Brain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Exercise plus cognitive training, Exercise plus cognitive stimulus at home.
Who it may be relevant to
Registry conditions: Elderly, Older Adults, Aging Brain. Basic parameters: from 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Executive function and processing speed by the Trail Making Test (TMT) [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]
Secondary outcome measures (8)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Esercizio Vita — Ferrara

Identifiers

NCT: NCT07244562 · 417/2025/Sper/UniFe

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗