ElderlyNCT04284709
Exergaming for Community-Dwelling Older Adults
A study testing cognitive-physical training in people with Elderly and Exercise, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
This study aimed to utilize an interactive exergame mat system to develop a novel cognitive-physical training program and explore the training effects on physical performance, cognitive function, dual-task walking (DTW), and fall risk compared to the control condition. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- cognitive-physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Nov 2018to 30 Apr 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 65 years or older, and being able to walk independently without any assistive devices
Who cannot join
- had severe lower-extremity joint pain, cognitive impairment, or visual problems that impeded their participation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei, 11219
About this study
Official title: Novel Mat Exergaming to Improve the Physical Performance, Cognitive Function, and Dual-task Walking and Decrease the Fall Risk of Community-dwelling Older Adults
This study aimed to utilize an interactive exergame mat system to develop a novel cognitive-physical training program and explore the training effects on physical performance, cognitive function, dual-task walking (DTW), and fall risk compared to the control condition.
Read the detailed description
The exercise group performed exergames with simultaneous cognitive-physical training, while the control group underwent a multicomponent exercise intervention focused on physical and cognitive training. A 2-hour training session was completed weekly for 3 months.
- Being tested
- cognitive-physical training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-physical trainingOther
combined physical and cognitive training
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | exergames with simultaneous cognitive-physical training Receives: Other: cognitive-physical training |
| control group | Active comparator | multicomponent exercise intervention focused on physical and cognitive training Receives: Other: cognitive-physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lower-limb muscle strength
30-second chair stand test
Measured: before and after 3-month exercise training interventions
change in upper-limb muscle strength
30-second arm curl test
Measured: before and after 3-month exercise training interventions
change in aerobic endurance
2-minute step test
Measured: before and after 3-month exercise training interventions
change in lower-body flexibility
chair sit and reach test
Measured: before and after 3-month exercise training interventions
change in upper-body flexibility
back scratch test
Measured: before and after 3-month exercise training interventions
change in dynamic balance
8-foot up and go test
Measured: before and after 3-month exercise training interventions
change in static balance
single-leg stand test
Measured: before and after 3-month exercise training interventions
change in grasp strength
hand grip strength
Measured: before and after 3-month exercise training interventions
change in lower limb motor function
foot tapping test
Measured: before and after 3-month exercise training interventions
change in cognitive function
Montreal Cognitive Assessment
Measured: before and after 3-month exercise training interventions
change in cognitive dual-task walking
8-foot up and go walking while counting
Measured: before and after 3-month exercise training interventions
change in motor dual-task walking
8-foot up and go walking while carrying a tray
Measured: before and after 3-month exercise training interventions
change in fall risk
fall risk questionnaire
Measured: before and after 3-month exercise training interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start14 Nov 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CY Song, National Taipei University of Nursing and Health Sciences
- Investigators
- Chen-Yi Song, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284709
- Sponsor's protocol ID
- 18-116-B
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Mat Exergaming to Improve the Physical Performance, Cognitive Function, and Dual-task Walking and Decrease the Fall Risk of Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04284709
- Acronym / sponsor ID
- 18-116-B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 26 Feb 2020 (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.
This study aimed to utilize an interactive exergame mat system to develop a novel cognitive-physical training program and explore the training effects on physical performance, cognitive function, dual-task walking (DTW), and fall risk compared to the control condition.
Detailed description
The exercise group performed exergames with simultaneous cognitive-physical training, while the control group underwent a multicomponent exercise intervention focused on physical and cognitive training. A 2-hour training session was completed weekly for 3 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: cognitive-physical trainingexergames with simultaneous cognitive-physical training |
| control group | Active comparator | Other: cognitive-physical trainingmulticomponent exercise intervention focused on physical and cognitive training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- aged 65 years or older, and being able to walk independently without any assistive devices
Key exclusion criteria (1 listed)
- had severe lower-extremity joint pain, cognitive impairment, or visual problems that impeded their participation
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 |
|---|---|---|
| cognitive-physical trainingcombined physical and cognitive training | Other | control group, exercise group |
Primary outcome
change in lower-limb muscle strength
Time frame: before and after 3-month exercise training interventions
30-second chair stand test
change in upper-limb muscle strength
Time frame: before and after 3-month exercise training interventions
30-second arm curl test
change in aerobic endurance
Time frame: before and after 3-month exercise training interventions
2-minute step test
change in lower-body flexibility
Time frame: before and after 3-month exercise training interventions
chair sit and reach test
change in upper-body flexibility
Time frame: before and after 3-month exercise training interventions
back scratch test
change in dynamic balance
Time frame: before and after 3-month exercise training interventions
8-foot up and go test
change in static balance
Time frame: before and after 3-month exercise training interventions
single-leg stand test
change in grasp strength
Time frame: before and after 3-month exercise training interventions
hand grip strength
change in lower limb motor function
Time frame: before and after 3-month exercise training interventions
foot tapping test
change in cognitive function
Time frame: before and after 3-month exercise training interventions
Montreal Cognitive Assessment
change in cognitive dual-task walking
Time frame: before and after 3-month exercise training interventions
8-foot up and go walking while counting
change in motor dual-task walking
Time frame: before and after 3-month exercise training interventions
8-foot up and go walking while carrying a tray
change in fall risk
Time frame: before and after 3-month exercise training interventions
fall risk questionnaire
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 26 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Elderly
RecruitingPhase 4
Efficacy and Safety of Polatuzumab Vedotin, Rituximab Combined With Reduced-dose Cyclophosphamide, Doxorubicin and Prednisone Regimen in the Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma: A Multicenter, Single-arm, Prospective Study
Diffuse Large B-Cell Lymphoma
RecruitingPhase 2
Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.
Hospital Associated Disability, Immobility
Not yet recruiting
Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study
Healthy Aging, Cognition
Active, not recruitingObservational study
Feasibility of Vision-Language Models for Detecting Physical Assistance as an Observable Criterion Defining GMFCS Levels in Children Aged 2 to 6 Years With Cerebral Palsy
Cerebral Palsy
Recruiting
Ring Fit Adventure for Functional Decline and Fall Risk in Community-Dwelling Older Adults
Functional Decline
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.
Chen-Yi Song principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive-physical training in people with Elderly and Exercise, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 1 inclusion and 1 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 26 Feb 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 Taiwan. 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?
change in lower-limb muscle strength (time frame: before and after 3-month exercise training interventions). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2020.