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Completed

NCT Number: NCT07036224

The Effectiveness of Training Using Exergaming on Selected Physical and Psychological Parameters in a Population of Patients Over the Age of 65 Belonging to Specific Subgroups of the Frailty Syndrome

This study aims to evaluate the effects of a six-week exergaming-based training program on physical and psychological parameters in individuals aged 65 and older diagnosed with frailty or pre-frailty. Participants engage in supervised exergame sessions twice weekly using the Activlife rehabilitation platform, which combines physical exercises with cognitive tasks in a virtual environment. Outcomes are assessed using validated tools including the Fried Frailty Criteria, CES-D, IPAQ-SF, Katz ADL, Lawton IADL, VES-13, Tinetti Test, and Fullerton Fitness Test. Anthropometric and functional data are collected before and after the intervention.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Modelowa Praktyka Lekarza Rodzinnego Maria Bujnowska-Fedak

Wroclaw, Lower Silesian Voivodeship, 51-141, Poland

About this study

Frailty is a clinical syndrome marked by reduced physiological reserve and increased vulnerability to adverse outcomes. Exergaming-interactive video game-based physical activity-offers a novel and potentially effective approach to counteracting physical and cognitive decline in frail older adults. While promising, existing evidence remains limited and methodologically heterogeneous.

This single-center trial investigates the effects of a six-week structured exergame training program on physical performance, functional independence, cognitive function, and mental well-being in a population of individuals aged 65+ with pre-frailty or frailty syndrome according to the Fried criteria.

Participants engage in at least 30-minute exergame-based sessions twice per week using the Activlife rehabilitation platform. The platform combines Kinect-based motion tracking with immersive therapeutic games that include physical (strength, balance, endurance) and cognitive (memory, visuospatial, logic) tasks. Sessions are supervised by a trained therapist, and game difficulty is adapted biweekly to participant capacity.

Assessments are conducted pre- and post-intervention and include: anthropometric data, frailty status (Fried criteria), depression symptoms (CES-D), physical activity (IPAQ-SF), basic and instrumental activities of daily living (Katz ADL, Lawton IADL), vulnerability (VES-13), mobility and balance (Tinetti Test), and physical fitness (Fullerton Fitness Test).

Ethical approval was obtained from the Bioethics Committee of Wroclaw Medical University (approval no. 172/2019). All participants provided written informed consent. The study adheres to the Declaration of Helsinki.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • no medical contraindications to performing physical exercises in a standing position

Exclusion criteria

  • diagnosed moderate or severe stage of dementia
  • the presence of chronic diseases (e.g. chronic obstructive pulmonary disease, asthma, heart failure, arterial hypertension) that were uncontrolled or in an exacerbation phase

Treatment and study plan

Exergaming Training using Kinect sensor device

Device

A 6-week standardized training program was carried out with the use of the game rehabilitation platform with Kinect sensor device. The subjects exercised under the supervision of an instructor for at least 30 minutes twice a week.

Primary outcomes

  1. Change in Frailty Category Based on Fried Frailty Phenotype Criteria

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    Frailty status will be assessed using the Fried Frailty Phenotype, which includes five criteria: unintentional weight loss, weakness (handgrip strength), slowness (gait speed), exhaustion (CES-D), and low physical activity (IPAQ-SF). Each criterion met scores 1 point (range: 0-5). Participants are classified as: robust (0 points), pre-frail (1-2 points), or frail (≥3 points). The outcome is the change in frailty category from baseline to study completion. Improvement is defined as transition to a lower-risk category (e.g., frail to pre-frail), while worsening is a shift to a higher-risk category. A decrease in frailty category indicates improvement.

Secondary outcomes

  1. Frailty Score Assessed by Fried Frailty Phenotype Scale

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    Frailty will be assessed using the Fried frailty phenotype scale, which includes five criteria: unintentional weight loss, weakness (handgrip strength), slowness (gait speed), exhaustion (CES-D items), and low physical activity (IPAQ-SF). The score ranges from 0 to 5; higher scores indicate a worse frailty status.

  2. Depression Symptoms Assessed by the Geriatric Depression Scale (GDS-15)

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The Geriatric Depression Scale (GDS-15) includes 15 yes/no questions. Scores range from 0 to 15; higher scores indicate more severe depressive symptoms. A score ≥6 indicates increased risk of depression.

  3. Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The MoCA evaluates cognitive domains including memory, attention, and visuospatial abilities. Total score ranges from 0 to 30; higher scores indicate better cognitive function. A score below 26 suggests mild cognitive impairment.

  4. Functional Status Assessed by the Katz Index of Independence in Activities of Daily Living (ADL)

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The ADL index assesses six basic self-care activities. Scores range from 0 to 6; higher scores indicate greater independence.

  5. Instrumental Activities of Daily Living Assessed by the Lawton-Brody Scale (IADL)

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The IADL scale evaluates 8 instrumental daily tasks. Scores range from 8 to 24; higher scores indicate greater functional independence.

  6. Physical Fitness Assessed by the Fullerton Fitness Test (Senior Fitness Test)

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The Fullerton Fitness Test evaluates physical fitness in older adults across six domains.

    Chair Stand Test: number of stands in 30 seconds (lower body strength). Arm Curl Test: arm curls in 30 seconds with 2 kg (women) or 3.6 kg (men) dumbbell (upper body strength).

    Chair Sit and Reach: distance (cm) between fingertips and toes while reaching forward from a seated position (lower body flexibility).

    Back Scratch Test: distance (cm) between fingertips reaching behind the back (upper body flexibility).

    8-Foot Up and Go: time (sec) to stand, walk 2.44 m, turn, and sit (balance/agility).

    6-Minute Walk or 2-Minute Step: total distance or number of steps (aerobic endurance).

    Each test is scored separately; higher values generally indicate better fitness, except for the Up and Go test, where lower times reflect better performance.

  7. Balance and Gait Assessed by the Tinetti Performance-Oriented Mobility Assessment (POMA)

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The POMA evaluates balance and gait. Scores range from 0 to 28; scores <25 indicate risk of falling, and <19 indicate high fall risk.

  8. Health-Related Quality of Life Assessed by the Short Form-36 (SF-36) Health Survey

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The SF-36 measures quality of life across 8 domains. Scores range from 0 to 100 for each domain; higher scores indicate better perceived health.

  9. Functional Vulnerability Assessed by the Vulnerable Elders Survey-13 (VES-13)

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The VES-13 evaluates self-reported physical function and age-related risk. Scores range from 0 to 10; a score ≥3 indicates increased risk of functional decline.

  10. Depression Symptoms Assessed by the Geriatric Depression Scale (GDS-15)

    Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)

    The Geriatric Depression Scale (GDS-15) is a screening tool consisting of 15 yes/no questions. Scores range from 0 to 15; higher scores indicate more severe depressive symptoms. A score of 6 or higher suggests an increased risk of depression in older adults.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Acronym: FREX

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 29, 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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