Recruiting

LudoFit

Sponsor:

Shirley Huang

Code:

NCT05993013

Conditions

Accidental Falls

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

LudoFit

Study Details

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

Study ID

NCT05993013

Start date

Jan 1, 2024

Status verified date

Apr, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Conventional exercise

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.

experimental: Game-based exercise

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.

Interventions

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.

Primary outcome measure

  • Physical function test 1-Berg Balance Scale [ Time Frame: 3 months ]
  • Physical function test 2-Timed Up and Go Test [ Time Frame: 3 months ]
  • Physical function test 3-Five Time Sit to Stand Test [ Time Frame: 3 months ]
  • Conventional exercise cohort - Exercise adherence [ Time Frame: 3 months ]
  • LudoFit exercise cohort - Exercise adherence [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

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

613-798-5555shhuang@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1Y4E9

Contacts

Shirley CC Huang

613-761-4645shhuang@toh.ca

Taryn Mackenzie

613-798-5555tmackenzie@toh.ca

More Information

Sponsor

Shirley Huang

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Keywords

  • Geriatric medicine
  • Falls risk
  • Exercise
  • Technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shirley Huang on 2024-04-03.