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

NCT ID: NCT07244562

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elderly Older Adults, Aging Brain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Exercise plus cognitive training

Intervention Type 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.

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

Group Type EXPERIMENTAL

Exercise plus cognitive stimulus at home

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università degli Studi di Ferrara

OTHER

Sponsor Role collaborator

University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fabio Manfredini

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fabio Manfredini, MD, PhD

Role: STUDY_CHAIR

Università degli Studi di Ferrara

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Esercizio Vita

Ferrara, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Luca Pomidori, PhD

Role: CONTACT

00393455984607

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

417/2025/Sper/UniFe

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.