Frailty SyndromeFREXNCT07036224
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
A study testing Exergaming Training using Kinect sensor device in people with Frailty Syndrome, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty Syndrome
- What is being tested?
- Exergaming Training using Kinect sensor device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2022to 14 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- no medical contraindications to performing physical exercises in a standing position
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Modelowa Praktyka Lekarza Rodzinnego Maria Bujnowska-Fedak
Wroclaw, Lower Silesian Voivodeship, 51-141
About this study
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.
Read the detailed description
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.
- Conditions
- Frailty Syndrome
- Being tested
- Exergaming Training using Kinect sensor device
- Keywords
- frailty, older people, exergaming
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming Training using Kinect sensor deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Exergaming Training using Kinect sensor device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Secondary outcomes (10)
Frailty Score Assessed by Fried Frailty Phenotype Scale
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.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Depression Symptoms Assessed by the Geriatric Depression Scale (GDS-15)
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.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
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.
Measured: 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)
The ADL index assesses six basic self-care activities. Scores range from 0 to 6; higher scores indicate greater independence.
Measured: 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)
The IADL scale evaluates 8 instrumental daily tasks. Scores range from 8 to 24; higher scores indicate greater functional independence.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Physical Fitness Assessed by the Fullerton Fitness Test (Senior Fitness Test)
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.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Balance and Gait Assessed by the Tinetti Performance-Oriented Mobility Assessment (POMA)
The POMA evaluates balance and gait. Scores range from 0 to 28; scores <25 indicate risk of falling, and <19 indicate high fall risk.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Health-Related Quality of Life Assessed by the Short Form-36 (SF-36) Health Survey
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.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Functional Vulnerability Assessed by the Vulnerable Elders Survey-13 (VES-13)
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.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Depression Symptoms Assessed by the Geriatric Depression Scale (GDS-15)
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.
Measured: Baseline and through completion of exergaming training program (an average of 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Mar 2022
- Primary completion30 Nov 2024
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036224
- Sponsor's protocol ID
- Frailty Exergaming KB172/2019
- Acronym
- FREX
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bujnowska-Fedak MM, Sobieski M, Fedak A, Waligora J. The ActivLife exergame rehabilitation program improves functional abilities in pre-frail and frail older adults: a clinical trial. Sci Rep. 2026 Mar 9;16(1):12637. doi: 10.1038/s41598-026-38989-4.
PubMed 41796126
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07036224
- Acronym / sponsor ID
- FREX / Frailty Exergaming KB172/2019
- Conditions
- Frailty Syndrome
- Keywords
- frailty, older people, exergaming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exergaming Training | Other | Device: Exergaming Training using Kinect sensor deviceA 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- no medical contraindications to performing physical exercises in a standing position
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergaming Training using Kinect sensor deviceA 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 |
Primary outcome
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.
10 secondary outcomes
Frailty Score Assessed by Fried Frailty Phenotype Scale
Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)
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)
Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and through completion of exergaming training program (an average of 6 weeks)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Derived from this study: PubMed 41796126Bujnowska-Fedak MM, Sobieski M, Fedak A, Waligora J. The ActivLife exergame rehabilitation program improves functional abilities in pre-frail and frail older adults: a clinical trial. Sci Rep. 2026 Mar 9;16(1):12637. doi: 10.1038/s41598-026-38989-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming Training using Kinect sensor device in people with Frailty Syndrome, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07036224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.