Effects of Physical Exercise and Cognitive Training on Quality of Life in Elderly Adults

NCT ID: NCT07244536

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2028-10-31

Brief Summary

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The aim of the study is to investigate the effectiveness of three 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 adults, who are most at risk of functional and cognitive decline

Detailed Description

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Conditions

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Elderly (People Aged 65 or More)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Structured Exercise Program + 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 TRAINING WITH OR WITHOUT MEDICATION

Intervention Type BEHAVIORAL

In addition to the exercise training, people 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.

Structured Exercise Program + Cognitive stimulus

In addition to the exercise program, people 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 TRAINING WITH OR WITHOUT MEDICATION

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.

Structured Exercise Program

The 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.

The exercise program will be the same for all the three groups

Group Type ACTIVE_COMPARATOR

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Intervention Type BEHAVIORAL

The 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.

Interventions

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EXERCISE TRAINING WITH OR WITHOUT MEDICATION

The 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 TRAINING WITH OR WITHOUT MEDICATION

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 TRAINING WITH OR WITHOUT MEDICATION

In addition to the exercise training, people 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

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Inclusion Criteria

* Male and female
* Age ≥ 70 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

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role collaborator

University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Fabio Manfredini

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Esercizio Vita

Ferrara, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Pomidori Principal Investigator, PhD

Role: CONTACT

00393455984607

Facility Contacts

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Luca Pomidori, PhD

Role: primary

00393455984607

Other Identifiers

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416/2025/Sper/UniFe

Identifier Type: -

Identifier Source: org_study_id

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