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
FREX
1 other identifier
interventional
111
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2025
CompletedFirst Submitted
Initial submission to the registry
June 5, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedJune 29, 2025
June 1, 2025
2.8 years
June 5, 2025
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Frailty Category Based on Fried Frailty Phenotype Criteria
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.
Baseline and through completion of exergaming training program (an average of 6 weeks)
Secondary Outcomes (10)
Frailty Score Assessed by Fried Frailty Phenotype Scale
Baseline and through completion of exergaming training program (an average of 6 weeks)
Depression Symptoms Assessed by the Geriatric Depression Scale (GDS-15)
Baseline and through completion of exergaming training program (an average of 6 weeks)
Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
Baseline and through completion of exergaming training program (an average of 6 weeks)
Functional Status Assessed by the Katz Index of Independence in Activities of Daily Living (ADL)
Baseline and through completion of exergaming training program (an average of 6 weeks)
Instrumental Activities of Daily Living Assessed by the Lawton-Brody Scale (IADL)
Baseline and through completion of exergaming training program (an average of 6 weeks)
- +5 more secondary outcomes
Study Arms (1)
Exergaming Training
OTHERA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- no medical contraindications to performing physical exercises in a standing position
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Modelowa Praktyka Lekarza Rodzinnego Maria Bujnowska-Fedak
Wroclaw, Lower Silesian Voivodeship, 51-141, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2025
First Posted
June 25, 2025
Study Start
March 1, 2022
Primary Completion
November 30, 2024
Study Completion
January 14, 2025
Last Updated
June 29, 2025
Record last verified: 2025-06