Accidental FallsNCT05993013
Improving Strength and Balance Through Exercise With LudoFit
A study testing LudoFit in people with Accidental Falls, run by Shirley Huang at 1 site in Canada.
Trial summary
The goal of this mixed methods cohort study is to explore how an innovative game-based, technology-enabled home exercise software compares to a conventional home-based exercise program in older adults at risk for falls. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Accidental Falls
- What is being tested?
- LudoFit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2024to Mar 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is interested in a home-based exercise program.
- The patient is independent with activities of daily living and instrumental activities of daily living.
- Patient agrees to return for 3-month follow-up.
- Patient must speak English or French.
Who cannot join
- Patient has the following physical functional performance:
- Berg Balance Scale score of 45 or less
- Unable to safely and independently reach at least 5 inches to the side and forward
- Unable to safely and independently reach down, touch floor and then return to start position
- Patient has diagnosed or suspected cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y4E9
Shirley CC Huang, 613-761-4645, shhuang@toh.ca
Taryn Mackenzie, 613-798-5555 ext. 10225, tmackenzie@toh.ca
About this study
Official title: Improving Strength and Balance in Older Adults at Risk of Falls With the LudoFit Exercise Program
The goal of this mixed methods cohort study is to explore how an innovative game-based, technology-enabled home exercise software compares to a conventional home-based exercise program in older adults at risk for falls. The main question[s] it aims to answer are:
- Does the exercise software lead to better or similar adherence to exercise recommendations compared to the conventional exercise program?
- Does the exercise software improve user strength and balance, as measured by relevant physical function scores?
- Do participants find the exercise software enjoyable and acceptable?
Read more
Participants will be approached during their initial fall risk assessment to see if they are interested in taking part. Those who agree to participate will choose either the exercise software or the conventional exercise program and will be instructed to:
- Perform their respective exercise program for a minimum of 3 times a week for 3 months.
- Return to clinic in 3 months to see our C-FAST physiotherapist for reassessment of their relevant physical functional tests.
- For conventional exercise program only - Document exercise compliance in an exercise log.
- For software program only - Complete a survey regarding the use of the technology.
Researchers will compare software-use cohort versus conventional exercise program cohort to see if adherence and physical function scores are comparable.
Read the detailed description
This study will take place in the Champlain Falls Assessment and Streamlined Treatment (C-FAST) clinic at the Ottawa Hospital, Division of Geriatric Medicine. This clinic receives patient referrals from the community for fall risk assessment. It strives to see older adults early in their 'falls history' with the goal of promoting their independence and avoiding unnecessary health care utilization due to falls and related injuries. Each patient receives a comprehensive fall risk assessment and individualized, evidenced-based, interventions/recommendations to address their fall risk, including physiotherapist-prescribed strength and balance exercises. The investigators want to find out whether delivering a home-based exercise program using video game-based technology may be acceptable to our patient population and possibly improve adherence to exercise intervention. The investigators will partner with Jintronix, a company that was founded to bring interactive technology to rehabilitation and senior care. LudoFit is one of Jintronix' s latest software programs where older adults participate in strength and balance exercises using an innovative game-based, technology-enabled home exercise software. The investigators want to conduct a study in our clinic where older adults have the option of choosing to exercise using LudoFit software instead of the conventional home-based exercise program and to see whether they show good compliance to exercises, improvement in their specific strength and balance scores and find this method an acceptable and fun way to exercise.
- Conditions
- Accidental Falls
- Being tested
- LudoFit
- Keywords
- Geriatric medicine, Falls risk, Exercise, Technology
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LudoFitOther
Game-based, technology-enabled home exercise software, done at least 3 times per week. Video games for a variety of exercises that promote balance, strength, endurance, and coordination.
| Study group | Role | What they receive |
|---|---|---|
| Conventional exercise | No intervention | Normally physiotherapist-recommended, tailored strength and balance exercises. These exercises are given in printed handouts and demonstrated by our physiotherapist with the patients during their initial clinic visit. Exercise is recommended to be done at least 3 times per week. |
| Game-based exercise | Experimental | Strength and balance exercises using the LudoFit game-based exercise software. Participants will be registered on the platform. Exercise is recommended to be done at least 3 times per week. Receives: Other: LudoFit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function test 1-Berg Balance Scale
Berg Balance Scale is a series of balance maneuvers administered by a physiotherapist to assess the balance of a subject. It is scored from 0 to 56. The higher the score the better the balance. Subject scores are also compared to age-matched normative values. This measure will be collected at initial clinic visit and then again at 3-month follow-up visit and the values compared for any improvement.
Measured: 3 months
Physical function test 2-Timed Up and Go Test
Timed Up and Go Test documents time taken in seconds for a subject stand up from a chair, walk 3 meters forward and then return to the chair and sit down. The longer the time taken, the worse the outcome. Taking over 14 seconds in Timed Up and Go Test correlates with increased risk of falls. This measure will be collected at initial clinic visit and then again at 3-month follow-up visit and the values compared for any improvement.
Measured: 3 months
Physical function test 3-Five Time Sit to Stand Test
Five Times Sit to Stand test scoring is based on the amount of time (to the nearest decimal in seconds) a subject is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test. Subject scores are also compared to age-matched normative values. This measure will be collected at initial clinic visit and then again at 3-month follow-up visit and the values compared for any improvement.
Measured: 3 months
Conventional exercise cohort - Exercise adherence
Participants will be given an exercise log at the beginning of the study and asked to use this log to document frequency of exercise each week, minutes spent during each exercise session and any additional comments/feedback about each exercise session (e.g. any discomfort or difficulty performing the exercise). The researchers will collect the exercise log at the 3-month follow-up visit and the entries analyzed. The more frequently the exercises were performed measured in total number of days per week and total minutes spent exercising, the better. Any qualitative comments provide by subjects in the log will be collected and analyzed for any themes.
Measured: 3 months
LudoFit exercise cohort - Exercise adherence
LudoFit software automatically tracks user exercise adherence data, including minutes of use per day, as well as performance in each activity and rate of perceived exertion. This data will be downloaded by researchers and analyzed. The more frequently the exercises were performed measured in total number of days per week and total minutes spent exercising, the better.
Measured: 3 months
Secondary outcomes (1)
Satisfaction with LudoFit exercise software
Participants will be given a standardized paper survey to complete at the 3-month follow-up visit where they will answer questions pertaining to their user experience with the software, such as acceptability and usability. The survey includes both quantitative (13 statements where subjects rate their agreement with the statements on a 5-point Likert scale; the higher the score, the higher the agreement with the statement) and qualitative components (subjects can provide additional comments to express what they find most beneficial with using LudoFit software and what could have made their experience with LudoFit better).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Jan 2024
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Jintronix
- Responsible party
- Sponsor-investigator, Shirley Huang, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993013
- Sponsor's protocol ID
- 4829
- Status last verified
- Apr 2024
- First submitted
- 20 Jul 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Strength and Balance in Older Adults at Risk of Falls With the LudoFit Exercise Program
- ClinicalTrials.gov ID
- NCT05993013
- Acronym / sponsor ID
- 4829
- Conditions
- Accidental Falls
- Keywords
- Geriatric medicine, Falls risk, Exercise, Technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shirley HuangUniversity, hospital or other
- Collaborators
- Jintronix
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 Aug 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 mixed methods cohort study is to explore how an innovative game-based, technology-enabled home exercise software compares to a conventional home-based exercise program in older adults at risk for falls. The main question[s] it aims to answer are:
- Does the exercise software lead to better or similar adherence to exercise recommendations compared to the conventional exercise program?
- Does the exercise software improve user strength and balance, as measured by relevant physical function scores?
- Do participants find the exercise software enjoyable and acceptable?
Participants will be approached during their initial fall risk assessment to see if they are interested in taking part. Those who agree to participate will choose either the exercise software or the conventional exercise program and will be instructed to:
- Perform their respective exercise program for a minimum of 3 times a week for 3 months.
- Return to clinic in 3 months to see our C-FAST physiotherapist for reassessment of their relevant physical functional tests.
- For conventional exercise program only - Document exercise compliance in an exercise log.
- For software program only - Complete a survey regarding the use of the technology.
Researchers will compare software-use cohort versus conventional exercise program cohort to see if adherence and physical function scores are comparable.
Detailed description
This study will take place in the Champlain Falls Assessment and Streamlined Treatment (C-FAST) clinic at the Ottawa Hospital, Division of Geriatric Medicine. This clinic receives patient referrals from the community for fall risk assessment. It strives to see older adults early in their 'falls history' with the goal of promoting their independence and avoiding unnecessary health care utilization due to falls and related injuries. Each patient receives a comprehensive fall risk assessment and individualized, evidenced-based, interventions/recommendations to address their fall risk, including physiotherapist-prescribed strength and balance exercises. The investigators want to find out whether delivering a home-based exercise program using video game-based technology may be acceptable to our patient population and possibly improve adherence to exercise intervention. The investigators will partner with Jintronix, a company that was founded to bring interactive technology to rehabilitation and senior care. LudoFit is one of Jintronix' s latest software programs where older adults participate in strength and balance exercises using an innovative game-based, technology-enabled home exercise software. The investigators want to conduct a study in our clinic where older adults have the option of choosing to exercise using LudoFit software instead of the conventional home-based exercise program and to see whether they show good compliance to exercises, improvement in their specific strength and balance scores and find this method an acceptable and fun way to exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional exercise | No intervention | –Normally physiotherapist-recommended, tailored strength and balance exercises. These exercises are given in printed handouts and demonstrated by our physiotherapist with the patients during their initial clinic visit. Exercise is recommended to be done at least 3 times per week. |
| Game-based exercise | Experimental | Other: LudoFitStrength and balance exercises using the LudoFit game-based exercise software. Participants will be registered on the platform. Exercise is recommended to be done at least 3 times per week. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is interested in a home-based exercise program.
- The patient is independent with activities of daily living and instrumental activities of daily living.
- Patient agrees to return for 3-month follow-up.
- Patient must speak English or French.
Key exclusion criteria (5 listed)
- Patient has the following physical functional performance:
- Patient has diagnosed or suspected cognitive impairment.
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 |
|---|---|---|
| LudoFitGame-based, technology-enabled home exercise software, done at least 3 times per week. Video games for a variety of exercises that promote balance, strength, endurance, and coordination. | Other | Game-based exercise |
Primary outcome
Physical function test 1-Berg Balance Scale
Time frame: 3 months
Berg Balance Scale is a series of balance maneuvers administered by a physiotherapist to assess the balance of a subject. It is scored from 0 to 56. The higher the score the better the balance. Subject scores are also compared to age-matched normative values. This measure will be collected at initial clinic visit and then again at 3-month follow-up visit and the values compared for any improvement.
Physical function test 2-Timed Up and Go Test
Time frame: 3 months
Timed Up and Go Test documents time taken in seconds for a subject stand up from a chair, walk 3 meters forward and then return to the chair and sit down. The longer the time taken, the worse the outcome. Taking over 14 seconds in Timed Up and Go Test correlates with increased risk of falls. This measure will be collected at initial clinic visit and then again at 3-month follow-up visit and the values compared for any improvement.
Physical function test 3-Five Time Sit to Stand Test
Time frame: 3 months
Five Times Sit to Stand test scoring is based on the amount of time (to the nearest decimal in seconds) a subject is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test. Subject scores are also compared to age-matched normative values. This measure will be collected at initial clinic visit and then again at 3-month follow-up visit and the values compared for any improvement.
Conventional exercise cohort - Exercise adherence
Time frame: 3 months
Participants will be given an exercise log at the beginning of the study and asked to use this log to document frequency of exercise each week, minutes spent during each exercise session and any additional comments/feedback about each exercise session (e.g. any discomfort or difficulty performing the exercise). The researchers will collect the exercise log at the 3-month follow-up visit and the entries analyzed. The more frequently the exercises were performed measured in total number of days per week and total minutes spent exercising, the better. Any qualitative comments provide by subjects in the log will be collected and analyzed for any themes.
LudoFit exercise cohort - Exercise adherence
Time frame: 3 months
LudoFit software automatically tracks user exercise adherence data, including minutes of use per day, as well as performance in each activity and rate of perceived exertion. This data will be downloaded by researchers and analyzed. The more frequently the exercises were performed measured in total number of days per week and total minutes spent exercising, the better.
1 secondary outcome
Satisfaction with LudoFit exercise software
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LudoFit in people with Accidental Falls, run by Shirley Huang at 1 site in Canada.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Apr 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley Huang, MD, FRCPC, MSc, MSc (HQ) (613-798-5555 ext. 14195, shhuang@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function test 1-Berg Balance Scale (time frame: 3 months). The study lists 5 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 3 Apr 2024.