Improving Strength and Balance Through Exercise With LudoFit

Accidental Falls Clinical Trial

Official title:

Improving Strength and Balance in Older Adults at Risk of Falls With the LudoFit Exercise Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05993013
• Other study ID #: 4829
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: Shirley Huang, MD, FRCPC, MSc, MSc (HQ)
• Phone: 613-798-5555
• Email: shhuang[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient has the following physical functional performance:

1. Berg Balance Scale score of 45 or less

2. Unable to safely and independently reach at least 5 inches to the side and forward

3. Unable to safely and independently reach down, touch floor and then return to start position

• Patient has diagnosed or suspected cognitive impairment.

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• LudoFit
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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Huang	Jintronix

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	3 months
Secondary	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).	3 months