- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743363
Effects of Exergaming Session Frequency on Work Performance, Cognition, and Mobility in Adults Age 55 to 65
April 26, 2020 updated by: Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
Aim - determine the immediate and lasting effects of Exergaming frequency on work performance, health, motor, and cognitive function in clerical employees.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Somogy
-
Kaposvár, Somogy, Hungary, 7400
- Somogy Megyei Kaposi Mór Oktató Kórház
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age
- active worker
- no detected neurological status
Exclusion Criteria:
- Sever heart problem
- Sever demeanor
- Alkoholism
- Drug problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exergame 3/week
The group does active training for 8 weeks after not training.
|
virtual training 3 times a week(8 week-long)
|
|
Experimental: Exergame 2/week
The group does active training for 8 weeks after not training.
|
virtual training 2 times a week(8 week-long)
|
|
Experimental: Healthy control / Exergame 1/week
In the first 8 week-long only control group, The group will do 1 training/week for the next 8 weeks.
|
In the first 8 week-long only control group.
For the next 8 weeks, the control group will do 1 workout per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor function
Time Frame: 8 weeks
|
Step test (as described by Prieske et al, motion and endurance test)
|
8 weeks
|
|
Motor Function
Time Frame: 8 weeks
|
Grip strength - Chair rise (as part of SPPB) the higher score better performance
|
8 weeks
|
|
MOBILITY
Time Frame: 8 weeks
|
-SPPB - the higher score better performance
|
8 weeks
|
|
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
|
8 weeks
|
|
Cognitive function
Time Frame: 8 weeks
|
- MMSE (questionnaire…) the higher score better performance
|
8 weeks
|
|
Cognitive function
Time Frame: 8 weeks
|
- Processing speed: The Digit Symbol Substitution Test (DSST)
|
8 weeks
|
|
Mobility
Time Frame: 8 weeks
|
6MWT - The longer the journey is, the better the performance
|
8 weeks
|
|
Mobility
Time Frame: 8 weeks
|
Fast gait speed over 10 m - speed, the faster the better
|
8 weeks
|
|
Cognitive function
Time Frame: 8 weeks
|
Verbal and visual memory span and working memory (0-100 visual analog sclae-the higher score better performance)
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2018
Primary Completion (Actual)
January 15, 2019
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
November 6, 2018
First Submitted That Met QC Criteria
November 14, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
April 28, 2020
Last Update Submitted That Met QC Criteria
April 26, 2020
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IKEB009/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.