AgedCOCARENCT05751551
Feasibility and Effectiveness of a Home-based Motor-cognitive Training Program in Older Adults
A study testing Personalized, home-based motor-cognitive training in people with Aged and Independent Living, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The goal of this clinical study is to test feasibility and effectiveness of a personalized, home-based motor-cognitive training program in community-dwelling older adults with prescription for rehabilitation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aged, Independent Living
- What is being tested?
- Personalized, home-based motor-cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Feb 2023to 9 Feb 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with prescription for rehabilitation (as in- or outpatient)
- Mini-Mental State Examination (MMSE) score ≥ 24
- Physically able to independently stand for at least 2 minutes
- Able to give informed consent as documented by signature
- Access to the internet at home
- Availability of a TV or large screen at home
Who cannot join
- Nursing home resident
- Mobility limitations or comorbidities impairing the ability to conduct a step-based motor-cognitive training
- Cognitive limitations or comorbidities impairing the ability to conduct a step-based motor-cognitive training
- Previous or current major psychiatric illness (e.g., schizophrenia, bipolar disorder, recur-rent major depression episodes)
- History of drug or alcohol abuse
- Terminal illness
Show all 9Show fewer
- Severe sensory impairments
- Participation in another clinical trial/intervention study
- More than 2 weeks absence in the next 3-4 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness of a Personalized, Home-based Motor-cognitive Training Program in Community-dwelling Older Adults - a Pragmatic Pilot Randomized Controlled Trial
The goal of this clinical study is to test feasibility and effectiveness of a personalized, home-based motor-cognitive training program in community-dwelling older adults with prescription for rehabilitation.
Participants will conduct a motor-cognitive intervention program which is based on exergames (=interactive video games controlled by body movements), added to usual care for 2 weeks in rehabilitation centers (face-to-face supervision) and for 10 weeks at home (remotely supervised).
Researchers will compare an intervention group and a control group to compare possible effects of the home-based study intervention to the effect of usual care alone on cognition, physical functions, and balance confidence.
Read the detailed description
Age-related declines in physical and cognitive functioning and the associated adverse outcomes such as restricted mobility, cognitive impairment, and falls ultimately result in a decrease of older adults' quality of life. In the light of the demographic change, these age-related declines gain special importance. Attempting to counteract these declines, previous studies have revealed that simultaneous motor and cognitive training may be equally or even more effective than separate training. In fact, simultaneous motor-cognitive training has shown to improve various physical, cognitive, and psychological functions in older adults - for instance balance, gait, executive control, processing speed, exercise enjoyment, depressive symptoms, and quality of life. However, most training programs are provided face-to-face, and accessibility is a major concern for older adults, especially in the post-pandemic era. Besides, due to the demographic change there is an increased need for long-term care/treatment challenging the health care system (in terms of finance, time, and personnel). Home-based rehabilitation programs offer a cost-effective solution to these problems.
However, previous research either investigated home-based training approaches based on separate motor-cognitive training, or, in case of simultaneous motor-cognitive training approaches, these have been tested in rather specific older populations (e.g., stroke survivors, Parkinson patients, older adults with cognitive impairment) or in healthy older adults. Yet, simultaneous motor-cognitive training in the home setting should be feasible and effective in a broader population of older adults especially in those without long-term access to traditional rehabilitation interventions accompanying them to full recovery. For this reason, this study aims to test the feasibility of a personalized, simultaneous motor-cognitive home-based training approach based on exergames for geriatric patients and to evaluate its effectiveness compared to usual care alone on physical and cognitive functions as well as on fall-related self-efficacy.
Potential participants will be screened and if eligible, asked if they are interested in partaking. All eligible and interested possible participants will be orally informed about the study and receive a written study information explaining the aim of the study, procedures, risks, and benefits of participation, as well as their rights and duties in case of participation. All participants will sign a written consent form, before any study-specific actions are performed.
The study will start with a baseline assessment. Then, participants will be randomized to either the intervention or the control group applying permuted block randomization. Subsequently, participants of the intervention group will perform 6 supervised, personalized motor-cognitive training sessions in a rehabilitation centre (ideally within 2 weeks) for about 20-30 minutes per session (familiarization period). Afterwards, participants of the intervention group will continue the training independently at home for 10 weeks, 3 times/week for about 20-30 minutes with the investigators supervising them via phone calls and regular personal visits. Physical and cognitive tests will be the basis for individual training plans which will further on be regularly adapted based on progression rules. All motor-cognitive training sessions in both intervention phases will be additional to usual care. The control group receives no additional training besides usual care. Participants of all groups will conduct 3 measurement sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment).
- Conditions
- Aged, Independent Living
- Being tested
- Personalized, home-based motor-cognitive training
- Keywords
- Motor-cognitive intervention, Exergames, Telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized, home-based motor-cognitive trainingOther
The simultaneous motor-cognitive training in this study will be conducted in form of exergames (interactive video games) using Senso hardware (DIV-SENSO-H, Dividat GmbH, Schindellegi, Switzerland) - a stepping platform with 5 pressure sensitive plates which is connected to a screen. For the home-based training, a more mobile version of the Dividat Senso will be used: a foldable pressure-sensitive mat. In both devices, stimuli of exergames appear on the screen and the participants have to react by stepping in one of 4 directions (front, back, left, right).
The motor-cognitive training approach allows targeting different cognitive functions such as attention, executive functions, memory, and visuo-spatial functions as well as balance, and strength.
FITT-VP principles will serve as a guideline but based on the functional status of each participant (physical and cognitive), the training sessions will be personalized in terms of training content, intensity and duration.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will conduct a motor-cognitive training program added to usual care. The intervention starts with a familiarization period in rehabilitation centers (face-to-face supervision) for 2 weeks before participants of the intervention group continue it at home (under remote supervision) for 10 weeks with 3 training sessions per week for about 20-30 minutes.
Besides, participants of the intervention group will participate in 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment). Receives: Other: Personalized, home-based motor-cognitive training |
| Control group | No intervention | The control group will continue with their usual care. Apart from that, they will only attend 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate
The duration of completed training sessions as percentages of the recommended duration of training sessions.
Measured: The adherence rate is assessed for all training sessions during the home-based intervention period, approximately for 10 weeks
Attrition rate
Number of participants lost during the trial will be recorded (drop-outs in both groups)
Measured: The attrition rate is assessed during the data collection period, an average of 12 weeks
Exergame Enjoyment Questionnaire (EEQ)
The EEQ will be used to measure exergame enjoyment in participants of the intervention group. The questionnaire consists of 20 statements rated on a five-point Likert scale which results in a minimum possible score of 20 and a maximum possible score of 100. A higher score reflects greater exergame enjoyment.
Measured: The EEQ is completed by the intervention group at T3 (post-measurement), thus about 12 weeks after study entry. The survey lasts 5-10 minutes
Secondary outcomes (13)
National Aeronautics and Space Administration-Task Load Index (NASA-TLX)
The NASA-TLX is a self-report, multidimensional assessment tool that rates perceived workload in order to assess a task, a system, or other aspects of performance (in this case the DIVIDAT exergames). It contains five subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort and Frustration. Each subscale can be given a score between 0 and 20. A higher score reflects a higher workload.
Measured: The NASA-TLX is completed by the intervention group at T3 (post-measurement), thus about 12 weeks after study entry. The survey lasts 5-10 minutes.
Additional instructions
It will be noted by the investigators whether additional instructions were required by the participants of the intervention group, meaning the instructions provided by the system were not enough.
Measured: Additional instructions will be collected throughout the whole home-based intervention period, an average of 10 weeks
Help requests
The number of help requests by the participants of the intervention group will be noted by the investigators (e.g. in case of technical problems and understanding difficulties)
Measured: The number of help requests will be collected throughout the whole home-based intervention period, an average of 10 weeks
Intention to continue the training program
The intention of participants of the intervention group to continue a similar home-based motor-cognitive training program after the project will be assessed with a single question. Answer will be given on a 5 point Likert scale (1=strongly disagree, 5=strongly agree)
Measured: The assessment will take place at T3 (post-measurement), thus about 12 weeks after study entry. The survey takes about 30 seconds.
Changes in psychomotor speed
The Reaction Time Test (RTT) conducted on the Dividat Senso measures psychomotor speed in terms of reaction to visual stimuli using the lower extremities in 6 directions (front right, front left, right, left, back right \& back left). Reaction time is measured [ms].
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The RTT lasts 5 minutes.
Changes in selective attention
To assess selective attention, the Go-Nogo Test will be conducted on the Dividat Senso. It evaluates the ability to suppress a response in the presence of irrelevant stimuli as well as the response latency during stimulus selection. Participants will be asked to react as fast as possible when a cross (x) is presented on the screen. However, in case the stimulus is a plus (+), they must remain still. Reaction time is measured [ms].
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about after 2 and 12 weeks after study entry. The GoNogo Test lasts 5 minutes.
Changes in cognitive flexibility
Cognitive flexibility will be assessed with the Flexibility Test conducted on the Dividat Senso. The test assesses the flexibility of focused attention. Participants are instructed to react with a step towards a rounded figure and then an angular figure in an alternating manner. Reaction time is measured [ms].
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Flexibility Test lasts 5 minutes.
Changes in static balance
Static balance will be assessed with the Sway Test conducted on the Dividat Senso. Participants are instructed to stand as still as possible for 30 seconds. Movements of the COP are collected [in mm] - the shorter the better is the static balance.
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Sway Test lasts about 1-2 minutes.
Changes in dynamic balance
Dynamic balance will be assessed with the Coordinated Stability Test conducted on the Dividat Senso. At the beginning, participants are instructed to stand follow a shown figure with the COP. The trace length of the COP is recorded [in mm] - longer length means less dynamic balance.
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Coordinated Stability Test lasts about 4 minutes.
Changes in functional balance
To assess functional balance, the Timed up and go Test (TUG) will be performed. It requires the participant to rise from a standard arm chair, walk 3 meters at a comfortable walking speed, turn, return, and sit down on the chair again. Time to complete the task is recorded in seconds.
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The TUG tests take about 2 minutes.
Changes in functional balance and dual task
To measure dual task, the TUG dual task (TUG-DT) will be performed. Thereby, the motor task of the TUG test (getting up from a chair, walk three meters, come back and sit down again) will be complemented with a cognitive task. For the cognitive task, participants are instructed to count backwards from 90, subtracting 7 successively. The time until the patient is fully seated again is recorded. Then, the dual task cost will be calculated by determining the percentage at which the cognitive task interfered on the test performance (DTC [%] = 100*(simple task score - DT score)/simple task score).
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The TUG-DT takes about 2 minutes.
Changes in strength (Lower limb power)
Strength/Lower limb power will be assessed with the 30 seconds Sit-to-Stand Test (STS). The participants will start sitting on a chair and after a countdown, they must stand up straight and sit down again as many times as possible within a time frame of 30 seconds. Meanwhile, the number of times the patient fully stands up from the chair will be counted.
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The STS tests takes about 2 minutes.
Changes in balance confidence
Balance confidence will be assessed with the Activities-specific Balance Confidence (ABC) Scale. The ABC Scale is measuring fall associated self-efficacy of a person in different activities and situations (e.g. stair climbing and walking on icy pavements).The scale is a 0% to 100% continuous response scale. The overall score is calculated by adding the item scores and dividing the total by 16 (i.e. the number of items). This total score ranges from 0% to 100% with.0% reflecting no confidence and 100% reflecting complete confidence.
Measured: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The survey lasts about 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start22 Feb 2023
- Primary completion31 Jan 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for AgedStudies 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
- Model description
- This study will be conducted as an international, pragmatic pilot randomized controlled trial with two treatment arms, an intervention group (IG) and a control group (CG). It comprises a two-week intervention period in a rehabilitation clinic (for familiarization purpose) followed by a 10-week training period at home. It involves three trial partners: ETH Zürich, Don Carlo Gnocchi Foundation (Fondazione Don Carlo Gnocchi (FDG), Milan, Italy), and Materia Agecare ((MAT), Nicosia, Cyprus). The study conduction will take place at all three trial sites.
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Seinsche, M.Sc., Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751551
- Sponsor's protocol ID
- BASEC-Nr. 2022-01746
- Acronym
- COCARE
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Herold F, Hamacher D, Schega L, Muller NG. Thinking While Moving or Moving While Thinking - Concepts of Motor-Cognitive Training for Cognitive Performance Enhancement. Front Aging Neurosci. 2018 Aug 6;10:228. doi: 10.3389/fnagi.2018.00228. eCollection 2018.
PubMed 30127732Huber SK, Knols RH, Arnet P, de Bruin ED. Motor-cognitive intervention concepts can improve gait in chronic stroke, but their effect on cognitive functions is unclear: A systematic review with meta-analyses. Neurosci Biobehav Rev. 2022 Jan;132:818-837. doi: 10.1016/j.neubiorev.2021.11.013. Epub 2021 Nov 20.
PubMed 34815131Lauenroth A, Ioannidis AE, Teichmann B. Influence of combined physical and cognitive training on cognition: a systematic review. BMC Geriatr. 2016 Jul 18;16:141. doi: 10.1186/s12877-016-0315-1.
PubMed 27431673Kraft E. Cognitive function, physical activity, and aging: possible biological links and implications for multimodal interventions. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2012;19(1-2):248-63. doi: 10.1080/13825585.2011.645010.
PubMed 22313174Tait JL, Duckham RL, Milte CM, Main LC, Daly RM. Influence of Sequential vs. Simultaneous Dual-Task Exercise Training on Cognitive Function in Older Adults. Front Aging Neurosci. 2017 Nov 7;9:368. doi: 10.3389/fnagi.2017.00368. eCollection 2017.
PubMed 29163146Yang C, Moore A, Mpofu E, Dorstyn D, Li Q, Yin C. Effectiveness of Combined Cognitive and Physical Interventions to Enhance Functioning in Older Adults With Mild Cognitive Impairment: A Systematic Review of Randomized Controlled Trials. Gerontologist. 2020 Nov 23;60(8):633-642. doi: 10.1093/geront/gnz149.
PubMed 31697831Morat M, Bakker J, Hammes V, Morat T, Giannouli E, Zijlstra W, Donath L. Effects of stepping exergames under stable versus unstable conditions on balance and strength in healthy community-dwelling older adults: A three-armed randomized controlled trial. Exp Gerontol. 2019 Nov;127:110719. doi: 10.1016/j.exger.2019.110719. Epub 2019 Sep 9.
PubMed 31513877Wuest S, Borghese NA, Pirovano M, Mainetti R, van de Langenberg R, de Bruin ED. Usability and Effects of an Exergame-Based Balance Training Program. Games Health J. 2014 Apr 1;3(2):106-114. doi: 10.1089/g4h.2013.0093.
PubMed 24804155Swanenburg J, Wild K, Straumann D, de Bruin ED. Exergaming in a Moving Virtual World to Train Vestibular Functions and Gait; a Proof-of-Concept-Study With Older Adults. Front Physiol. 2018 Jul 31;9:988. doi: 10.3389/fphys.2018.00988. eCollection 2018.
PubMed 30108511Adcock M, Fankhauser M, Post J, Lutz K, Zizlsperger L, Luft AR, Guimaraes V, Schattin A, de Bruin ED. Effects of an In-home Multicomponent Exergame Training on Physical Functions, Cognition, and Brain Volume of Older Adults: A Randomized Controlled Trial. Front Med (Lausanne). 2020 Jan 28;6:321. doi: 10.3389/fmed.2019.00321. eCollection 2019.
PubMed 32047751Adcock M, Thalmann M, Schattin A, Gennaro F, de Bruin ED. A Pilot Study of an In-Home Multicomponent Exergame Training for Older Adults: Feasibility, Usability and Pre-Post Evaluation. Front Aging Neurosci. 2019 Nov 22;11:304. doi: 10.3389/fnagi.2019.00304. eCollection 2019.
PubMed 31824295Tillou A, Kelley-Quon L, Burruss S, Morley E, Cryer H, Cohen M, Min L. Long-term postinjury functional recovery: outcomes of geriatric consultation. JAMA Surg. 2014 Jan;149(1):83-9. doi: 10.1001/jamasurg.2013.4244.
PubMed 24284836Allegue DR, Higgins J, Sweet SN, Archambault PS, Michaud F, Miller W, Tousignant M, Kairy D. Rehabilitation of Upper Extremity by Telerehabilitation Combined With Exergames in Survivors of Chronic Stroke: Preliminary Findings From a Feasibility Clinical Trial. JMIR Rehabil Assist Technol. 2022 Jun 22;9(2):e33745. doi: 10.2196/33745.
PubMed 35731560Gallou-Guyot M, Nuic D, Mandigout S, Compagnat M, Welter ML, Daviet JC, Perrochon A. Effectiveness of home-based rehabilitation using active video games on quality of life, cognitive and motor functions in people with Parkinson's disease: a systematic review. Disabil Rehabil. 2022 Dec;44(26):8222-8233. doi: 10.1080/09638288.2021.2022780. Epub 2022 Jan 4.
PubMed 34982599Gandolfi M, Geroin C, Dimitrova E, Boldrini P, Waldner A, Bonadiman S, Picelli A, Regazzo S, Stirbu E, Primon D, Bosello C, Gravina AR, Peron L, Trevisan M, Garcia AC, Menel A, Bloccari L, Vale N, Saltuari L, Tinazzi M, Smania N. Virtual Reality Telerehabilitation for Postural Instability in Parkinson's Disease: A Multicenter, Single-Blind, Randomized, Controlled Trial. Biomed Res Int. 2017;2017:7962826. doi: 10.1155/2017/7962826. Epub 2017 Nov 26.
PubMed 29333454
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Personalized, Home-based Motor-cognitive Training Program in Community-dwelling Older Adults - a Pragmatic Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05751551
- Acronym / sponsor ID
- COCARE / BASEC-Nr. 2022-01746
- Conditions
- Aged, Independent Living
- Keywords
- Motor-cognitive intervention, Exergames, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 2 Mar 2023 (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.
The goal of this clinical study is to test feasibility and effectiveness of a personalized, home-based motor-cognitive training program in community-dwelling older adults with prescription for rehabilitation.
Participants will conduct a motor-cognitive intervention program which is based on exergames (=interactive video games controlled by body movements), added to usual care for 2 weeks in rehabilitation centers (face-to-face supervision) and for 10 weeks at home (remotely supervised).
Researchers will compare an intervention group and a control group to compare possible effects of the home-based study intervention to the effect of usual care alone on cognition, physical functions, and balance confidence.
Detailed description
Age-related declines in physical and cognitive functioning and the associated adverse outcomes such as restricted mobility, cognitive impairment, and falls ultimately result in a decrease of older adults' quality of life. In the light of the demographic change, these age-related declines gain special importance. Attempting to counteract these declines, previous studies have revealed that simultaneous motor and cognitive training may be equally or even more effective than separate training. In fact, simultaneous motor-cognitive training has shown to improve various physical, cognitive, and psychological functions in older adults - for instance balance, gait, executive control, processing speed, exercise enjoyment, depressive symptoms, and quality of life. However, most training programs are provided face-to-face, and accessibility is a major concern for older adults, especially in the post-pandemic era. Besides, due to the demographic change there is an increased need for long-term care/treatment challenging the health care system (in terms of finance, time, and personnel). Home-based rehabilitation programs offer a cost-effective solution to these problems.
However, previous research either investigated home-based training approaches based on separate motor-cognitive training, or, in case of simultaneous motor-cognitive training approaches, these have been tested in rather specific older populations (e.g., stroke survivors, Parkinson patients, older adults with cognitive impairment) or in healthy older adults. Yet, simultaneous motor-cognitive training in the home setting should be feasible and effective in a broader population of older adults especially in those without long-term access to traditional rehabilitation interventions accompanying them to full recovery. For this reason, this study aims to test the feasibility of a personalized, simultaneous motor-cognitive home-based training approach based on exergames for geriatric patients and to evaluate its effectiveness compared to usual care alone on physical and cognitive functions as well as on fall-related self-efficacy.
Potential participants will be screened and if eligible, asked if they are interested in partaking. All eligible and interested possible participants will be orally informed about the study and receive a written study information explaining the aim of the study, procedures, risks, and benefits of participation, as well as their rights and duties in case of participation. All participants will sign a written consent form, before any study-specific actions are performed.
The study will start with a baseline assessment. Then, participants will be randomized to either the intervention or the control group applying permuted block randomization. Subsequently, participants of the intervention group will perform 6 supervised, personalized motor-cognitive training sessions in a rehabilitation centre (ideally within 2 weeks) for about 20-30 minutes per session (familiarization period). Afterwards, participants of the intervention group will continue the training independently at home for 10 weeks, 3 times/week for about 20-30 minutes with the investigators supervising them via phone calls and regular personal visits. Physical and cognitive tests will be the basis for individual training plans which will further on be regularly adapted based on progression rules. All motor-cognitive training sessions in both intervention phases will be additional to usual care. The control group receives no additional training besides usual care. Participants of all groups will conduct 3 measurement sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be conducted as an international, pragmatic pilot randomized controlled trial with two treatment arms, an intervention group (IG) and a control group (CG). It comprises a two-week intervention period in a rehabilitation clinic (for familiarization purpose) followed by a 10-week training period at home. It involves three trial partners: ETH Zürich, Don Carlo Gnocchi Foundation (Fondazione Don Carlo Gnocchi (FDG), Milan, Italy), and Materia Agecare ((MAT), Nicosia, Cyprus). The study conduction will take place at all three trial sites.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Personalized, home-based motor-cognitive trainingThe intervention group will conduct a motor-cognitive training program added to usual care. The intervention starts with a familiarization period in rehabilitation centers (face-to-face supervision) for 2 weeks before participants of the intervention group continue it at home (under remote supervision) for 10 weeks with 3 training sessions per week for about 20-30 minutes. Besides, participants of the intervention group will participate in 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment). |
| Control group | No intervention | –The control group will continue with their usual care. Apart from that, they will only attend 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with prescription for rehabilitation (as in- or outpatient)
- Mini-Mental State Examination (MMSE) score ≥ 24
- Physically able to independently stand for at least 2 minutes
- Able to give informed consent as documented by signature
- Access to the internet at home
Key exclusion criteria (9 listed)
- Nursing home resident
- Mobility limitations or comorbidities impairing the ability to conduct a step-based motor-cognitive training
- Cognitive limitations or comorbidities impairing the ability to conduct a step-based motor-cognitive training
- Previous or current major psychiatric illness (e.g., schizophrenia, bipolar disorder, recur-rent major depression episodes)
- History of drug or alcohol abuse
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 |
|---|---|---|
| Personalized, home-based motor-cognitive trainingThe simultaneous motor-cognitive training in this study will be conducted in form of exergames (interactive video games) using Senso hardware (DIV-SENSO-H, Dividat GmbH, Schindellegi, Switzerland) - a stepping platform with 5 pressure sensitive plates which is connected to a screen. For the home-based training, a more mobile version of the Dividat Senso will be used: a foldable pressure-sensitive mat. In both devices, stimuli of exergames appear on the screen and the participants have to react by stepping in one of 4 directions (front, back, left, right). The motor-cognitive training approach allows targeting different cognitive functions such as attention, executive functions, memory, and visuo-spatial functions as well as balance, and strength. FITT-VP principles will serve as a guideline but based on the functional status of each participant (physical and cognitive), the training sessions will be personalized in terms of training content, intensity and duration. | Other | Intervention group |
Primary outcome
Adherence rate
Time frame: The adherence rate is assessed for all training sessions during the home-based intervention period, approximately for 10 weeks
The duration of completed training sessions as percentages of the recommended duration of training sessions.
Attrition rate
Time frame: The attrition rate is assessed during the data collection period, an average of 12 weeks
Number of participants lost during the trial will be recorded (drop-outs in both groups)
Exergame Enjoyment Questionnaire (EEQ)
Time frame: The EEQ is completed by the intervention group at T3 (post-measurement), thus about 12 weeks after study entry. The survey lasts 5-10 minutes
The EEQ will be used to measure exergame enjoyment in participants of the intervention group. The questionnaire consists of 20 statements rated on a five-point Likert scale which results in a minimum possible score of 20 and a maximum possible score of 100. A higher score reflects greater exergame enjoyment.
13 secondary outcomes
National Aeronautics and Space Administration-Task Load Index (NASA-TLX)
Time frame: The NASA-TLX is completed by the intervention group at T3 (post-measurement), thus about 12 weeks after study entry. The survey lasts 5-10 minutes.
Additional instructions
Time frame: Additional instructions will be collected throughout the whole home-based intervention period, an average of 10 weeks
Help requests
Time frame: The number of help requests will be collected throughout the whole home-based intervention period, an average of 10 weeks
Intention to continue the training program
Time frame: The assessment will take place at T3 (post-measurement), thus about 12 weeks after study entry. The survey takes about 30 seconds.
Changes in psychomotor speed
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The RTT lasts 5 minutes.
Changes in selective attention
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about after 2 and 12 weeks after study entry. The GoNogo Test lasts 5 minutes.
Changes in cognitive flexibility
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Flexibility Test lasts 5 minutes.
Changes in static balance
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Sway Test lasts about 1-2 minutes.
Changes in dynamic balance
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Coordinated Stability Test lasts about 4 minutes.
Changes in functional balance
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The TUG tests take about 2 minutes.
Changes in functional balance and dual task
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The TUG-DT takes about 2 minutes.
Changes in strength (Lower limb power)
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The STS tests takes about 2 minutes.
Changes in balance confidence
Time frame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The survey lasts about 10 minutes.
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 15 Feb 2024.
- Background: PubMed 30127732Herold F, Hamacher D, Schega L, Muller NG. Thinking While Moving or Moving While Thinking - Concepts of Motor-Cognitive Training for Cognitive Performance Enhancement. Front Aging Neurosci. 2018 Aug 6;10:228. doi: 10.3389/fnagi.2018.00228. eCollection 2018.
- Background: PubMed 34815131Huber SK, Knols RH, Arnet P, de Bruin ED. Motor-cognitive intervention concepts can improve gait in chronic stroke, but their effect on cognitive functions is unclear: A systematic review with meta-analyses. Neurosci Biobehav Rev. 2022 Jan;132:818-837. doi: 10.1016/j.neubiorev.2021.11.013. Epub 2021 Nov 20.
- Background: PubMed 27431673Lauenroth A, Ioannidis AE, Teichmann B. Influence of combined physical and cognitive training on cognition: a systematic review. BMC Geriatr. 2016 Jul 18;16:141. doi: 10.1186/s12877-016-0315-1.
- Background: PubMed 22313174Kraft E. Cognitive function, physical activity, and aging: possible biological links and implications for multimodal interventions. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2012;19(1-2):248-63. doi: 10.1080/13825585.2011.645010.
- Background: PubMed 29163146Tait JL, Duckham RL, Milte CM, Main LC, Daly RM. Influence of Sequential vs. Simultaneous Dual-Task Exercise Training on Cognitive Function in Older Adults. Front Aging Neurosci. 2017 Nov 7;9:368. doi: 10.3389/fnagi.2017.00368. eCollection 2017.
- Background: PubMed 31697831Yang C, Moore A, Mpofu E, Dorstyn D, Li Q, Yin C. Effectiveness of Combined Cognitive and Physical Interventions to Enhance Functioning in Older Adults With Mild Cognitive Impairment: A Systematic Review of Randomized Controlled Trials. Gerontologist. 2020 Nov 23;60(8):633-642. doi: 10.1093/geront/gnz149.
- Background: PubMed 31513877Morat M, Bakker J, Hammes V, Morat T, Giannouli E, Zijlstra W, Donath L. Effects of stepping exergames under stable versus unstable conditions on balance and strength in healthy community-dwelling older adults: A three-armed randomized controlled trial. Exp Gerontol. 2019 Nov;127:110719. doi: 10.1016/j.exger.2019.110719. Epub 2019 Sep 9.
- Background: PubMed 24804155Wuest S, Borghese NA, Pirovano M, Mainetti R, van de Langenberg R, de Bruin ED. Usability and Effects of an Exergame-Based Balance Training Program. Games Health J. 2014 Apr 1;3(2):106-114. doi: 10.1089/g4h.2013.0093.
- Background: PubMed 30108511Swanenburg J, Wild K, Straumann D, de Bruin ED. Exergaming in a Moving Virtual World to Train Vestibular Functions and Gait; a Proof-of-Concept-Study With Older Adults. Front Physiol. 2018 Jul 31;9:988. doi: 10.3389/fphys.2018.00988. eCollection 2018.
- Background: PubMed 32047751Adcock M, Fankhauser M, Post J, Lutz K, Zizlsperger L, Luft AR, Guimaraes V, Schattin A, de Bruin ED. Effects of an In-home Multicomponent Exergame Training on Physical Functions, Cognition, and Brain Volume of Older Adults: A Randomized Controlled Trial. Front Med (Lausanne). 2020 Jan 28;6:321. doi: 10.3389/fmed.2019.00321. eCollection 2019.
- Background: PubMed 31824295Adcock M, Thalmann M, Schattin A, Gennaro F, de Bruin ED. A Pilot Study of an In-Home Multicomponent Exergame Training for Older Adults: Feasibility, Usability and Pre-Post Evaluation. Front Aging Neurosci. 2019 Nov 22;11:304. doi: 10.3389/fnagi.2019.00304. eCollection 2019.
- Background: PubMed 24284836Tillou A, Kelley-Quon L, Burruss S, Morley E, Cryer H, Cohen M, Min L. Long-term postinjury functional recovery: outcomes of geriatric consultation. JAMA Surg. 2014 Jan;149(1):83-9. doi: 10.1001/jamasurg.2013.4244.
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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.
Julia Seinsche, M.Sc. principal investigator
ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized, home-based motor-cognitive training in people with Aged and Independent Living, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 6 inclusion and 9 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 15 Feb 2024. 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 Switzerland. 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?
Adherence rate (time frame: The adherence rate is assessed for all training sessions during the home-based intervention period, approximately for 10 weeks). The study lists 3 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 NCT05751551, which also lists 21 linked publications.
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 15 Feb 2024.