Digitally Delivered Exercise for Falls Prevention

DW
RM
Overseen ByRyan Moran, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital exercise program designed to prevent falls in older adults. The researchers aim to determine if this program effectively reduces fall risk by comparing two groups: one begins the exercise immediately, while the other waits. It suits individuals aged 60 or older who are mobile, including those using a cane or walker, and have internet access. Participants must also complete a short questionnaire to assess their fall risk. As a Phase 2 trial, this research measures the program's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digitally delivered exercise program is safe for fall prevention in older adults?

Research has shown that digital exercise programs to prevent falls are generally safe for participants. Past studies focusing on exercises to improve strength and balance have successfully reduced the risk of falls. These exercises form a key part of the digital program being tested.

One study found that these digital programs are not only effective but also popular with older adults. Most studies reported no injuries, and any minor injuries were rare, indicating that participants handle the exercises well.

In summary, evidence supports the safety of digital exercise programs for preventing falls. These programs are safe and usually receive positive feedback from participants.12345

Why are researchers excited about this trial?

Researchers are excited about digitally delivered exercise for falls prevention because it offers a unique approach to improving balance and strength without needing in-person classes or sessions. Unlike traditional exercise programs, which often require regular visits to a gym or therapy center, this method allows participants to engage in tailored exercises from the comfort of their homes using digital platforms. This digital approach not only increases accessibility for those who may have mobility issues or live in remote areas but also provides a personalized experience that can adapt to individual progress. By making exercise more accessible and convenient, there's potential to significantly reduce the risk of falls, a major concern for older adults.

What evidence suggests that this digitally delivered exercise program is effective for fall prevention?

Research has shown that exercise programs delivered through digital platforms can help reduce the risk of falls in older adults. One study found that video-based exercises lowered fall incidents by 45% for older adults living in the community. Additionally, exercises focused on building strength and improving balance have consistently reduced fall risk. Reviews of multiple studies highlight a 9% reduction in falls for older adults at risk when using digital exercise games. This trial will compare two approaches: Group A will start their 12-week exercise program immediately, while Group B will begin after a 12-week lead-in period. These findings suggest that such programs could be a promising way to help prevent falls among older individuals.12678

Who Is on the Research Team?

CK

Caroline Kumstra, PhD

Principal Investigator

Sanford Burnham Prebys

RM

Ryan Moran, MD, MPH

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for older adults interested in preventing falls. Participants should be at lower to moderate risk of falling and willing to engage in a digitally delivered exercise program. The study includes an initial 12-week intensive exercise phase, with an optional additional 12 weeks for those who complete most classes, followed by a washout period.

Inclusion Criteria

Completion of the Stopping Elderly Accidents, Deaths & Injuries (STEADI) Stay Independent Risk for Falling Questionnaire (uploaded as Supporting materials). NOTE: A score of 7 or greater will make a participant ineligible for this study (see below)
I understand and can agree to the study's procedures and risks.
I am willing and able to follow the study rules and attend all appointments.
See 2 more

Exclusion Criteria

I use a wheelchair for mobility.
Score 7 or more on the STEADI Risk for Falling questionnaire
Individuals who have non removable (i.e. implanted) electrically driven medical implants (pacemakers, cochlear implants, etc)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Exercise

Group A starts a 12-week intensive exercise program, while Group B has a 12-week life as normal period.

12 weeks
Weekly virtual sessions

Maintenance Exercise

Participants who complete the intensive exercise are invited to a 12-week maintenance exercise program.

12 weeks
Weekly virtual sessions

Washout

Group A undergoes a 12-week washout period, while Group B starts their intensive exercise.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the exercise programs.

12 weeks
Measurements at baseline, 12, 24, and 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Digitally Delivered Exercise

Trial Overview

The trial tests a fall-prevention exercise program delivered digitally. Group A starts immediately with exercises and has a follow-up maintenance phase and washout period. Group B lives normally during Group A's first phase, then follows the same exercise regimen without the washout.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Immediate Intervention: Group AExperimental Treatment1 Intervention
Group II: Delayed Intervention: Group BExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Sanford Burnham Prebys

Collaborator

Trials
1
Recruited
90+

Citations

study protocol for the Safe Step randomised controlled trial

The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly ...

Strong Evidence: Randomized Digitally Delivered Fall ...

Specifically, targeted strength and balance exercise have consistently been shown to improve fall risk, and accordingly, the Centers for Disease ...

Usability and Feasibility P

This 12-week fall prevention program was well accepted and showed promise related to reducing fall risk in an older adult population. The ...

Effect of a video-assisted fall prevention program on ...

Video based exercise intervention can reduce the incidence of fall by 45 % in community-dwelling older adults. •. Strengthening, balance training, gait and dual ...

Opportunities to Digitally Enable Falls Prevention in Older ...

Two systematic reviews and meta-analyses demonstrated that exergames lead to a 9% reduction in falls incidence for at-risk older adults and ...

Nonrandomized Interventional Study of a Novel, Digitally ...

Targeted exercise has been shown to improve fall risk, and recommendations for identifying and referring older adults for exercise-based ...

Feasibility of a Multicomponent Digital Fall Prevention ...

This study has successfully demonstrated that a multicomponent digital fall prevention exercise intervention is feasible and acceptable for at-risk older adults ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40902150/

Digitally Delivered, Group-Based Exercise Interventions for ...

Among the studies that provided data on adverse events, most were conducted without injuries or reported only minor injuries. More than 60% of ...