NCT07036224

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

June 5, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

frailtyolder peopleexergaming

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

OTHER

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.

Device: Exergaming Training using Kinect sensor device

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.

Exergaming Training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

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

Locations