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

NCT07244562 | Not Yet Recruiting

• 1 other identifier: 417/2025/Sper/UniFe
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Elderly; Older Adults, Aging Brain

Outcome Measures

Primary Outcomes (1)

• Executive function and processing speed by the Trail Making Test (TMT)

  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.

  Baseline; end of the program (3-month); Follow-up (6-month)

Secondary Outcomes (8)

• Quality of life by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire

  Baseline; end of the program (3-month); Follow-up (6-month)

• Quality of life assessed by the short-form 36 (SF-36) questionnaire

  Baseline; end of the program (3-month); Follow-up (6-month)

• Cognition assessed by the Montreal Cognitive Assessment (MoCA)

  Baseline; end of the program (3-month); Follow-up (6-month)

• Walking endurance assessed by the 6-Minute Walking Test (6MWT)

  Baseline; end of the program (3-month); Follow-up (6-month)

• Physical performance assessed using the Short Physical Performance Battery (SPPB)

  Baseline; end of the program (3-month); Follow-up (6-month)

Study Arms (4)

Experimental 1 - Exercise plus cognitive training

EXPERIMENTAL

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 training

Experimental 2 - Exercise plus cognitive stimulus

EXPERIMENTAL

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

Behavioral: Exercise plus cognitive stimulus at home

Active comparator - Exercise only

ACTIVE COMPARATOR

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.

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Control group

NO INTERVENTION

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.

Interventions

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.

Experimental 2 - Exercise plus cognitive stimulus

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.

Active comparator - Exercise only

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.

Experimental 1 - Exercise plus cognitive training

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age ≥ 60 years
• Provision of the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: collaborator
• University Hospital of Ferrara: lead

Study Sites (1)

Esercizio Vita

Ferrara, 44124, Italy

Location

MeSH Terms

Interventions

Exercise; Dosage Forms; Cognitive Training

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fabio Manfredini, MD, PhD

  Università degli Studi di Ferrara

  STUDY CHAIR

Central Study Contacts

Luca Pomidori, PhD

CONTACT

00393455984607; info@eserciziovita.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-11

Locations

IT (1)