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NCT Number: NCT07244536

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

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

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Key information

Conditions

Elderly (People Aged 65 or More) Behavior Motor Activity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esercizio Vita

Ferrara, 44124, Italy

Location status: Recruiting

Location contact

Fabio Manfredini, PhD

SUB_INVESTIGATOR

Lorenzo Gamberini, MSc

SUB_INVESTIGATOR

Luca Pomidori, PhD

CONTACT

[email protected]

00393455984607

Michel Audiffren, PhD

SUB_INVESTIGATOR

Michele Felisatti, PhD

SUB_INVESTIGATOR

Nicola Lamberti, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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).

Secondary outcomes

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

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

    QOL-AD consists of 13 questions covering various aspects of daily life, such as physical health, energy, mood, relationships and the ability to enjoy enjoyable activities. The combined scores of the patient and caregiver provide a more comprehensive and accurate picture of the person's overall well-being. The scale has a score ranging from 13 (lowest quality of life) to 52 (highest quality of life).

  2. Cognitive capacity assessed by the Montreal Cognitive Assessment (MoCA)

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

    MoCA is a 30-point test evaluates cognitive function. Its primary purpose is to detect mild cognitive impairment (MCI). The score goes from 0 (maximal cognitive deficit) to 30 (normal cognitive function).

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

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

    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.

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

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

    The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters

  5. Short Physical Performance Battery (SPPB)

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

    It is a specific assessment for the elderly population, consisting of three functional tests that measure postural stability, the ability to walk safely, and lower limb muscle strength. Higher scores indicate better functional ability. The scale goes from 0 (lowest functional ability) to 12 (highest functional ability).

  6. Manual grip strength using the Handgrip Test (HT)

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

    The test is performed using a dynamometer: the subject grabs the handle of the device with maximum strength, and the maximum value of force expressed in kilograms is recorded.

  7. Sleep quality through the Pittsburgh Sleep Quality Index (PSQI)

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

    It refers to the last 30 days and analyses seven components. The total score ranges from 0 to 21. A score above 5 indicates poor sleep quality.

  8. Timed Up-and-Go test

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

    This test ask the participant to stand up from a standard chair, walk for three meters, turn around a cone and get back to the starting point and seating. The total timed elapsed will be collected

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Pomidori Principal Investigator, PhD

CONTACT

[email protected]

00393455984607

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • Università degli Studi di Ferrara

Registry information

Official study title

Health-related Quality of Life in Elderly Adults Following Physical Exercise and Cognitive Training: a Randomized-controlled Trial

Acronym: HELIOS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 24, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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