ExerG: An innovative digital solution to individually improve physical and cognitive functions using an exergame (video game-based) training in an ecologically valid and safe setting for the geriatric population

Organizational Data

DRKS-ID:
DRKS00025838
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2021-07-13
Last update in DRKS:
2022-10-06
Registration type:
Prospective

Acronym/abbreviation of the study

ExerG – ExerCube goes senior

URL of the study

https://exergetic.de/

Brief summary in lay language

Age-related falls are not uncommon. According to the World Health Organisation (WHO), 28-35% of people over the age of 65 fall at least once a year. Falls can lead to injuries and health limitations that can greatly affect social life and quality of life. Studies have shown that physical and cognitive training considerably improves walking and balance, and consequently reduces the risk of falls. There are several challenges to consider when developing suitable trainings as part of a therapy: The training should be structured in a way that it is easily understandable for the user, adaptable to the person, and motivating. As a training programme content, tasks like daily life activities have been found to be useful. The so-called "ExerG" project wants to realise this novel training measure and develop a first version of a video-game-like exercise programme (exergame) for older adults who are at risk of falling. This type of training is safe, transferable into real life and easily accessible. Users will be involved in the development of the training device, which will allow to respond closely to their needs, preferences and wishes. The project will therefore be divided into several phases, during which users will be interviewed and later test the training device. The ExerG project is funded by “AAL – Active Assistive Living Program Ageing Well in the Digital World”. It is co-financed by the European Commission through the Horizon 2020 Societal Challenge: Health, demographic change, wellbeing. The project consortium consists of scientific and commercial partners from Switzerland, Austria, and Canada. Partners from Switzerland are Sphery Ltd.; Reha Rheinfelden (RHF), and Zurich University of the Arts (ZHdK), Austrian partners are VASCage GmbH and Reha Zentrum Münster (RZM), and the Canadian partner is the HCI Games Group (HCIGG), Communication Arts Department, Stratford School of Interaction Design and Business, University of Waterloo. The first project phase consists of a guided group discussion (focus group study). Here, for example, the needs, preferences, opinions, and experiences of the later so-called "end users" will be asked. There will be three different focus groups. The first group will consist of the end users of the training device: people who are older than 65 years, with or without additional diseases, with a higher risk of falls. The second group will consist of staff from rehabilitation centres such as physiotherapists or sports scientists. The third group will include employees in leading positions at public healthcare payers (for example, health insurance companies), as well as other health care facilities. The group discussion of the first two groups will be a semi-structured interview, with the third group being interviewed individually by telephone for their opinions. The statements of all interviewees will be used to adapt an already existing exergame system of the company Sphery (Switzerland) to the needs of the elderly population. In this way, the users will be directly involved in the development of the new prototype (a first full-scale and functioning test model). In the second phase, the user-friendliness of the training device will be studied. In the final phase, the effectiveness of the exergame training device will be tested.

Brief summary in scientific language

Age-related falls are not uncommon. In the "Global Report on falls prevention in older age" (2007) of the World Health Organisation (WHO) states that about 28-35% of people over 65 years of age fall at least once per year. Falls can have long-term health consequences, involving psychological and social consequences that may subsequently significantly increase costs to health care providers. Systematic reviews show that physical and cognitive training significantly improves walking and postural control and consequently leads to a reduction in falls in older people (with or without disabilities). The development of a rehabilitative tool as a basis for therapeutic exercise training to improve physical and cognitive functions for fall prevention faces a variety of challenges: (1) User-centered focus to personalise training requirements on physical, cognitive and mental levels, (2) motivation to regularly train and exercise, (3) meaningfulness of the training regarding daily life activities and quality of life, (4) ecologically valid training setting allowing an everyday movement-based training, (5) accessibility of the training. The ExerG project aims to address these challenges by developing a prototype for a holistic training procedure using the so-called exergame for older adults ≥65 years at risk of falls. Exergames are computer-based therapeutic exercise games that have the potential to provide older adults at risk of falls with motivating, meaningful, user-centred, environmentally friendly, safe, and accessible training for the cognitive and physical functions. This approach will be applied to rehabilitation and prevention within the ExerG project. The ExerG project is funded by “AAL – Active Assistive Living Program Ageing Well in the Digital World”. It is co-financed by the European Commission through the Horizon 2020 Societal Challenge: Health, demographic change, wellbeing. The project consortium consists of scientific and commercial partners from Switzerland, Austria and Canada. Partners from Switzerland are Sphery Ltd.; Reha Rheinfelden (RHF), and Zurich University of the Arts (ZHdK), Austrian partners are VASCage GmbH and Reha Zentrum Münster (RZM), and the Canadian partner is the HCI Games Group (HCIGG), Communication Arts Department, Stratford School of Interaction Design and Business, University of Waterloo. The goal of the study is to develop and test an exergame device that meets the needs, desires, preferences of the end users. For this purpose, the study is divided into 3 phases: Phase 1- Focus group investigation of selected end users. Phase 2 -Usability testing. Phase 3 -Pilot RCT (randomised controlled trial). The purpose of this focus group investigation is to gain a deeper understanding of the needs, preferences, opinions, fears, and prior experiences of therapeutic exercise games using a computer (exergames). Three end-user groups will be examined. (1) Primary end-user group: people ≥65 years of age with or without comorbid conditions, at increased risk of falls. (2) Secondary end-user group: staff from rehabilitation centres such as physical therapists or sports scientists. (3) Tertiary end-user group: employees in managerial positions at public healthcare payers (for example, health insurance companies), as well as other health care facilities. The primary and secondary end-user groups will be encouraged to participate in guided focus group discussions using semi-structured interviews in their respective groups. Participants of the tertiary end-user group will be asked for their opinions in individual semi-structured telephone interviews. The collected focus group and interview data will be used for the development of the prototype, of which the hardware and software will be based on the existing ExerCube of the company Sphery (CH) and adapted to the needs of the end users. The usability of the ExerG version 1 will be tested in the second phase (usability testing). A pilot RCT will follow based on this in the third phase of the ExerG study.

Health condition or problem studied

ICD10:
I69 - Sequelae of cerebrovascular disease
ICD10:
R26 - Abnormalities of gait and mobility
ICD10:
G20 - Parkinson disease
ICD10:
G21 - Secondary parkinsonism
ICD10:
G35 - Multiple sclerosis
ICD10:
G81 - Hemiplegia
ICD10:
G82 - Paraplegia and tetraplegia
ICD10:
I61 - Intracerebral haemorrhage
ICD10:
I63 - Cerebral infarction
Free text:
Secondary end-users: no health problem, rehabilitation experts such as physiotherapists and sports scientists working at rehabilitation centres, geriatric institutions etc.
Free text:
Tertiary end-users: no health problem, employees in managerial positions at public healthcare payers (for example, health insurance companies), as well as other health care facilities
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Focus group investigation in primary end-users (older people who are aged 65 or over and at risk of falls), as well as in secondary end-users (physiotherapists and sports scientists who work in rehabilitation settings) and individual semi-structured telephone interviews in employees in managerial positions at public healthcare payers (for example, health insurance companies), as well as other health care facilities. In all three groups, the purpose is to learn about their needs, experiences, expectations and wishes regarding the novel development of the ExerG system (an exergame based training device with a specific fall prevention system for older people at risk of falls).

Endpoints

Primary outcome:
Insider in-depth-knowledge about primary and secondary end-users’ needs, opinions, preferences, fears and experiences of an ExerG training as a basis for the ExerG concept and corresponding hardware and software extensions. Outcome measurement: focus group investigation (primary and secondary end-users); additional collection of demographic (age, gender) and disease-specific (e.g., type of disease/diagnosis, disease duration and severity; primary end-users) or profession-specific data (e.g., profession, highest degree, work experience; secondary end-users).
Secondary outcome:
Insider in-depth knowledge about tertiary end-users’ opinions, preferences and experiences of an ExerG training as a basis for the ExerG concept and corresponding hardware and software extensions. Outcome measurement: semi-structured interviews; additional collection of demographic (age, gender) and profession-specific data (e.g., profession, highest degree, work experience).

Study Design

Purpose:
Health care system
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Canada
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Reha Rheinfelden Rheinfelden, Schweiz
  • Medical center Reha Zentrum Münster Münster, Österreich
  • Other Communication Arts Department, Stratford School of Interaction Design and Business, University of Waterloo Stratford, Ontario, Canada

Recruitment period and number of participants

Planned study start date:
2021-08-01
Actual study start date:
2021-08-02
Planned study completion date:
No Entry
Actual Study Completion Date:
2022-08-15
Target Sample Size:
60
Final Sample Size:
64

Inclusion Criteria

Sex:
All
Minimum Age:
65 Years
Maximum Age:
99 Years
Additional Inclusion Criteria:
Primary end-user group: older adults (geriatric population defined by the presence of a geriatric-typical multi-morbidity and an older age) at the risk of falling – (1) aged 65 years or older, (2) cognitive status allowing them to understand the study procedure/content and informed consent, (3) able to walk with or without a supportive device for 10 metres or are able, if wheelchair- dependent, to sit in a wheelchair without arm- and back rests. Secondary end-user group: healthcare providers working at health care services/institutions, e.g., rehabilitation centers, geriatric institutions/organisations e.g., physiotherapists or sports scientists. Tertiary end-user group: employees in managerial positions working at health insurers or public sector service organisers

Exclusion Criteria

Impaired cognition that disables consenting in participation; vision defect, inability to read, recognise pictures; severe comorbidities (such as severe psychiatric or neurological diseases) or terminal illness that interfere with the study participation; influence of medication which may impair cognition (e.g., morphine, neuroleptics, benzodiazepine). Older adults will be excluded if they present with a joint contracture (shoulder, knee, hip), psychiatric diseases, have a terminal illness with a prognosis of less than 12 months or intense pain during movements (> 5 on the Visual Analogue Scale)

Addresses

Primary Sponsor

Address:
VASCage GmbH Research Centre on Vascular Ageing and Stroke (für österr. Partner)
Innrain 66a
6020 Innsbruck
Austria
Telephone:
+43.512.554435
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.vascage.at/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Reha Rheinfelden
Dr. Corina Schuster-Amft
Salinenstrasse 98
4310 Rheinfelden
Austria
Telephone:
+41 61 836 53 81
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.reha-rheinfelden.ch/

Contact for Public Queries

Address:
Reha Zentrum Münster
Dr. Barbara Seebacher
Gröben 700
6232 Münster
Austria
Telephone:
+435337200046205
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.reha-muenster.at/

Principal Investigator

Address:
Reha Rheinfelden
Dr. Corina Schuster-Amft
Salinenstrasse 98
4310 Rheinfelden
Austria
Telephone:
+41 61 836 53 81
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.reha-rheinfelden.ch/

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Europäisches Förder-Programm AAL – Active Assistive Living Programme - Ageing Well in the Digital World
3, Rue du Luxembourg
1000 Brussels
Belgium
Telephone:
+32 2 219 92 25
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.aal-europe.eu/about/

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Innosuisse – Swiss Innovation Agency
Einsteinstrasse 2
3003 Bern
Switzerland
Telephone:
+41 58 461 61 61
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.innosuisse.ch/inno/en/home.html

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Canadian Institutes of Health Research (CIHR)
160 Elgin Street, 10th Floor
ON K1A 0W9 Address Locator 4809A
Canada
Telephone:
613-954-1968
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://cihr-irsc.gc.ca/e/193.html

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Österreichische Forschungsförderungsgesellschaft mbH(FFG)
Sensengasse 1
1090 Wien
Austria
Telephone:
+43 (0)5 7755 - 0
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.ffg.at/

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Reha Zentrum Münster Betriebs GmbH
Gröben 700
6232 Münster
Austria
Telephone:
+435337200046326
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.reha-muenster.at/

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der Medizinischen Universität Innsbruck [Ethikkommission der Medizinischen Universität Innsbruck, Österreich]
Innrain 43
6020 Innsbruck
Austria
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.i-med.ac.at/ethikkommission/

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2021-03-26
Ethics committee number:
1153/2021
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-06-02

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1267-8262
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Various dissemination channels will be used to ensure the availability of the project results for a wide range of stakeholders. Main stakeholders can already be identified: EU decision makers in the fields of public and private health care organisations and authorities, rehabilitation institutions, researchers in the field of AAL, fall prevention, physical-cognitive training, rehabilitation, and human computer interaction. Printed and electronic material about the concept and objectives will be generated in the form of a printed leaflet and on-going dissemination material, such as quarterly electronic newsletters on the social media channels of the consortium partners. At the later project phases, dissemination will focus on the distribution of the EXERGETIC project results and conclusions of the project in electronic format available on the website of the project. Furthermore, the web pages dedicated to the project will include all the non-confidential results of the project, important dates and events related to the community. In addition, there will be a number of knowledge-sharing events to bring together project participants, local experts, special interest groups, decision makers and interested participants to share knowledge being gained as the project progresses. These events will also be aimed at promoting best practices and sharing lessons learned. The partners will participate and represent the project in relevant scientific conferences, and they will visit sector events, information days and trade shows, including the interaction with other European Technology Platforms in the themes of interest, plus international events. Participation at the AAL Forum is planned in two years (2022 and 2023) to present project results and get into contact with the AAL community. In addition, consortium partners will participate in European and national panels and boards. In addition, the learning gained during the EXERGETIC project will be disseminated as widely and as effectively as possible e.g., also in materials suitable for education. The information gathered on the different testing stages will be used for subsequent dissemination of results and market implementation, always preserving the privacy of the involved end-users.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry