Condition category
Not Applicable
Date applied
13/12/2013
Date assigned
11/03/2014
Last edited
13/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study to test the effects of physical training with a video dance game on executive functions and frontal brain activity. Executive functions, a set of mental processes that helps connect past experience with present action, are used to perform activities such as planning, organizing, strategizing, paying attention to and remembering details. Our goal is to find the effects of the training programs on brain functions. The study's findings should help to improve the well-being of elderly and help prevent age-related changes in brain functioning.

Who can participate?
Men and women, aged over 70 years and able to walk independently for 10 minutes.

What does the study involve?
Participants will be randomly allocated to participate in one of two possible training programs. Group 1 receives a progressive dance video game training performed over 30 minutes, three times per week, on dance pads. The program lasts 8 weeks. Group 2 receives an intervention with progressive balance training and additional stretching exercises performed over 30 minutes, three times per week, on dance pads and the program lasts 8 weeks. At the beginning and end of the study, we will compare executive functioning and frontal brain activity while walking on a treadmill.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part but there should be benefits to elderly people in the future because the results of the study are likely to influence how fall prevention training should be designed.
The main risk of training is getting an injury because of increasing the difficulty of the exercise too quickly.

Where is the study run from?
The study has been set up by the Swiss Federal Institute of Technology in Zurich (Switzerland). Participants will be recruited in the city of St.Gallen, Switzerland and surrounding communities. Training intervention will take place in the Geriatrics Hospital St.Gallen.

When is the study starting and how long is it expected to run for?
Recruitment started in October 2013. Participants were enrolled on the study for a period of four months and the study completed in February 2014.

Who is funding the study?
Swiss Federal Institute of Technology (ETH) and Zurcher Kantonalbank (ZKB), Switzerland.

Who is the main contact?
Dr Eling D. de Bruin
eling.debruin@hest.ethz.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eling D. de Bruin

ORCID ID

Contact details

Inst.f.Bewegungswissenschaften und Sport
HIT J 32.3
Wolfgang-Pauli-Str. 27
Zurich
8093
Switzerland
+41 44 632 40 18
eling.debruin@hest.ethz.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EKSG 13/089

Study information

Scientific title

Pre-frontal brain activity during walking and executive functions following training: a functional near-infrared spectroscopy (fNIRS) study

Acronym

EXERBRAIN

Study hypothesis

We hypothesize that the prefrontal cortex will show changes in activation properties following a video-exergame training intervention in elderly.

Ethics approval

The Medical Ethics Committee of the Canton St. Gallen, Switzerland (EKSG 13/089)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Video-exergame training intervention in elderly

Intervention

Participants are randomised to one of two groups:
Intervention Group: Receives a progressive dance video game training performed during 30 minutes, three times per week, on dance pads. The program lasts 8 weeks.
Control Group: Receives an intervention with progressive balance training and additional stretching exercises for the same time period and with an equal frequency and training duration.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Near-infrared spectroscopic (NIRS) imaging to assess bilateral increase of oxygenated hemoglobin (oxyHb) in the prefrontal cortex during treadmill walking

Secondary outcome measures

1. Cognitive functioning (shifting, inhibition and updating): paper & pencil test / measured at baseline and three months
2. Short physical performance battery (SPPB): physical performance test / measured at baseline and three months

Overall trial start date

01/10/2013

Overall trial end date

28/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 65 years or older
2. Living independently or in a retirement home
3. Being able to walk 10 minutes without a break on a treadmill
4. Being healthy (self-reported)
5. Having given written informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Individuals who reported more than one serious health complaint (e.g. recent heart attack, uncontrolled diabetes or uncontrolled hypertension)
2. Individuals who reported diagnosis of Alzheimer's disease, dementia, or recent head injuries

Recruitment start date

01/10/2013

Recruitment end date

28/02/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

Inst.f.Bewegungswissenschaften und Sport
Zurich
8093
Switzerland

Sponsor information

Organisation

Swiss Federal Institute of Technology in Zurich (ETHZ) (Switzerland)

Sponsor details

c/o Dr. Eling Douwe de Bruin
Inst.f.Bewegungswissenschaften und Sport
HIT J 32.3
Wolfgang-Pauli-Str. 27
Zürich
8093
Switzerland
+41 44 632 40 18
eling.debruin@hest.ethz.ch

Sponsor type

University/education

Website

http://www.ibws.ethz.ch/people/debruine/index

Funders

Funder type

University/education

Funder name

Zurcher Kantonalbank (Switzerland) within the framework of sponsoring of movement sciences, sports and nutritional sciences at the Swiss Federal Institute of Technology in Zurich (ETHZ) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes