Improving Strength and Balance Through Exercise With LudoFit

NCT05993013 | Recruiting

• 1 other identifier: 4829
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Accidental Falls

Keywords

Geriatric medicine; Falls risk; Exercise; Technology

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Satisfaction with LudoFit exercise software

  3 months

Study Arms (2)

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.

Other: LudoFit

Interventions

LudoFit OTHER

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.

Game-based exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Huang: lead
• Jintronix: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Shirley Huang, MD, FRCPC, MSc, MSc (HQ)

CONTACT

613-798-5555; shhuang@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 15, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

CA (1)