Improving Strength and Balance Through Exercise With LudoFit

NCT ID: NCT05993013

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

LudoFit

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jintronix

UNKNOWN

Sponsor Role: collaborator

Shirley Huang

OTHER

Sponsor Role: lead

Responsible Party

Shirley Huang

Clinical Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

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

Role: CONTACT

shhuang@toh.ca

613-798-5555 ext. 14195

Facility Contacts

Shirley CC Huang

Role: primary

shhuang@toh.ca

613-761-4645

Taryn Mackenzie

Role: backup

tmackenzie@toh.ca

613-798-5555 ext. 10225

Other Identifiers

4829

Identifier Type: -

Identifier Source: org_study_id