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

NCT07244536 | Recruiting

• 1 other identifier: 416/2025/Sper/UniFe
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elderly (People Aged 65 or More)

Keywords

elderly; exercise; cognitive training; quality of life

Outcome Measures

Primary Outcomes (1)

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

  This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks. For each specific domain, the score ranges from 0 (lowest quality of life) to 100 (highest quality of life).

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

Secondary Outcomes (8)

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

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

• Cognitive capacity assessed by the Montreal Cognitive Assessment (MoCA)

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

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

  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)

• Short Physical Performance Battery (SPPB)

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

Study Arms (3)

Structured Exercise Program + 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 TRAINING WITH OR WITHOUT MEDICATION

Structured Exercise Program + Cognitive stimulus

EXPERIMENTAL

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.

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Structured Exercise Program

ACTIVE COMPARATOR

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

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION 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.

Structured Exercise Program

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male and female
• Age ≥ 70 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

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

Study Sites (1)

Esercizio Vita

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Dosage Forms

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Luca Pomidori Principal Investigator, PhD

CONTACT

00393455984607; luca.pomidori@gmail.com

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: November 15, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-11

Locations

IT (1)