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

University Hospital of Ferrara

Status: Not yet enrolling

Conditions: Older Adults, Aging Brain; Elderly

Treatments: Behavioral: Exercise plus cognitive training; Behavioral: Exercise plus cognitive stimulus at home; Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Study type: Interventional

Funder types: Other

Identifiers

NCT07244562

417/2025/Sper/UniFe

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 4 patient groups

Experimental 1 - Exercise plus cognitive training

Experimental group

Description:

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

Treatment:

Behavioral: Exercise plus cognitive training

Experimental 2 - Exercise plus cognitive stimulus

Experimental group

Description:

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

Treatment:

Behavioral: Exercise plus cognitive stimulus at home

Active comparator - Exercise only

Active Comparator group

Description:

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.

Treatment:

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Control group

No Intervention group

Description:

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.