HealthyNCT03743363
Effects of Exergaming Session Frequency on Work Performance, Cognition, and Mobility in Adults Age 55 to 65
A study testing Exergame 2/week and Exergaming 3/week in people with Healthy, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
Aim - determine the immediate and lasting effects of Exergaming frequency on work performance, health, motor, and cognitive function in clerical employees. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exergame 2/week and Exergaming 3/week
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteHungary
- Study dates
- 15 Nov 2018to 1 Feb 2019
- 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age
- active worker
- no detected neurological status
Who cannot join
- Sever heart problem
- Sever demeanor
- Alkoholism
- Drug problems
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, 7400
About this study
Aim - determine the immediate and lasting effects of Exergaming frequency on work performance, health, motor, and cognitive function in clerical employees.
Read the detailed description
Hypothesis - In sedentary clerical workers the introduction of even 1 session / week exercise can cause lasting and correlated improvements in work, motor, and cognitive function, and effect which plateaus at 2 compared with 3 sessions / week. However, 6 months follow up would show residual effects only at the 3/week frequency in those who had become sedentary again.
- Conditions
- Healthy
- Being tested
- Exergame 2/week, Exergaming 3/week, Healthy control / Exergaming 1/week
- Keywords
- balance, movement, exergaming, work performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame 2/weekOther
virtual training 2 times a week(8 week-long)
Exergaming 3/weekOther
virtual training 3 times a week(8 week-long)
Healthy control / Exergaming 1/weekOther
In the first 8 week-long only control group. For the next 8 weeks, the control group will do 1 workout per week.
| Study group | Role | What they receive |
|---|---|---|
| Exergame 3/week | Experimental | The group does active training for 8 weeks after not training. Receives: Other: Exergaming 3/week |
| Exergame 2/week | Experimental | The group does active training for 8 weeks after not training. Receives: Other: Exergame 2/week |
| Healthy control / Exergame 1/week | Experimental | In the first 8 week-long only control group, The group will do 1 training/week for the next 8 weeks. Receives: Other: Healthy control / Exergaming 1/week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function
Step test (as described by Prieske et al, motion and endurance test)
Measured: 8 weeks
Motor Function
Grip strength - Chair rise (as part of SPPB) the higher score better performance
Measured: 8 weeks
MOBILITY
-SPPB - the higher score better performance
Measured: 8 weeks
BALANCE Functional reach
Beam walking (4, 8, 12 cm 3 trials each, summed distance score) The longer the journey is, the better the performance
Measured: 8 weeks
Cognitive function
- MMSE (questionnaire…) the higher score better performance
Measured: 8 weeks
Cognitive function
- Processing speed: The Digit Symbol Substitution Test (DSST)
Measured: 8 weeks
Mobility
6MWT - The longer the journey is, the better the performance
Measured: 8 weeks
Mobility
Fast gait speed over 10 m - speed, the faster the better
Measured: 8 weeks
Cognitive function
Verbal and visual memory span and working memory (0-100 visual analog sclae-the higher score better performance)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start15 Nov 2018
- Primary completion15 Jan 2019
- Study completion1 Feb 2019
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 HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743363
- Sponsor's protocol ID
- IKEB009/2018
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hortobagyi T, Deak D, Farkas D, Blenyesi E, Torok K, Granacher U, Tollar J. Effects of Exercise Dose and Detraining Duration on Mobility at Late Midlife: A Randomized Clinical Trial. Gerontology. 2021;67(4):403-414. doi: 10.1159/000513505. Epub 2021 Mar 3.
PubMed 33657562
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exergaming Session Frequency on Work Performance, Cognition, and Mobility in Adults Age 55 to 65
- ClinicalTrials.gov ID
- NCT03743363
- Acronym / sponsor ID
- IKEB009/2018
- Conditions
- Healthy
- Keywords
- balance, movement, exergaming, work performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 16 Nov 2018 (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.
Aim - determine the immediate and lasting effects of Exergaming frequency on work performance, health, motor, and cognitive function in clerical employees.
Detailed description
Hypothesis - In sedentary clerical workers the introduction of even 1 session / week exercise can cause lasting and correlated improvements in work, motor, and cognitive function, and effect which plateaus at 2 compared with 3 sessions / week. However, 6 months follow up would show residual effects only at the 3/week frequency in those who had become sedentary again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exergame 3/week | Experimental | Other: Exergaming 3/weekThe group does active training for 8 weeks after not training. |
| Exergame 2/week | Experimental | Other: Exergame 2/weekThe group does active training for 8 weeks after not training. |
| Healthy control / Exergame 1/week | Experimental | Other: Healthy control / Exergaming 1/weekIn the first 8 week-long only control group, The group will do 1 training/week for the next 8 weeks. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age
- active worker
- no detected neurological status
Key exclusion criteria (4 listed)
- Sever heart problem
- Sever demeanor
- Alkoholism
- Drug problems
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 |
|---|---|---|
| Exergame 2/weekvirtual training 2 times a week(8 week-long) | Other | Exergame 2/week |
| Exergaming 3/weekvirtual training 3 times a week(8 week-long) | Other | Exergame 3/week |
| Healthy control / Exergaming 1/weekIn the first 8 week-long only control group. For the next 8 weeks, the control group will do 1 workout per week. | Other | Healthy control / Exergame 1/week |
Primary outcome
Motor function
Time frame: 8 weeks
Step test (as described by Prieske et al, motion and endurance test)
Motor Function
Time frame: 8 weeks
Grip strength - Chair rise (as part of SPPB) the higher score better performance
MOBILITY
Time frame: 8 weeks
-SPPB - the higher score better performance
BALANCE Functional reach
Time frame: 8 weeks
Beam walking (4, 8, 12 cm 3 trials each, summed distance score) The longer the journey is, the better the performance
Cognitive function
Time frame: 8 weeks
- MMSE (questionnaire…) the higher score better performance
Cognitive function
Time frame: 8 weeks
- Processing speed: The Digit Symbol Substitution Test (DSST)
Mobility
Time frame: 8 weeks
6MWT - The longer the journey is, the better the performance
Mobility
Time frame: 8 weeks
Fast gait speed over 10 m - speed, the faster the better
Cognitive function
Time frame: 8 weeks
Verbal and visual memory span and working memory (0-100 visual analog sclae-the higher score better performance)
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 28 Apr 2020.
- Derived from this study: PubMed 33657562Hortobagyi T, Deak D, Farkas D, Blenyesi E, Torok K, Granacher U, Tollar J. Effects of Exercise Dose and Detraining Duration on Mobility at Late Midlife: A Randomized Clinical Trial. Gerontology. 2021;67(4):403-414. doi: 10.1159/000513505. Epub 2021 Mar 3.
- Individual participant dataSharing planned: No
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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 Exergame 2/week and Exergaming 3/week in people with Healthy, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
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 3 inclusion and 4 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 28 Apr 2020. 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 Hungary. 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?
Motor function (time frame: 8 weeks). The study lists 9 primary outcomes in all. 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 NCT03743363, 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 28 Apr 2020.