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

University Hospital of Ferrara

Status: Enrolling

Conditions: Elderly (People Aged 65 or More)

Treatments: Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Study type: Interventional

Funder types: Other

Identifiers

NCT07244536

416/2025/Sper/UniFe

Details and patient eligibility

About

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

Enrollment: 156 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 3 patient groups

Structured Exercise Program + 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 TRAINING WITH OR WITHOUT MEDICATION

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Structured Exercise Program + Cognitive stimulus

Experimental group

Description:

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.

Treatment:

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Structured Exercise Program

Active Comparator group

Description:

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

Treatment:

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION