What side effects are associated with this type of intervention?

Exercise-based interventions like the Otago Exercise Program, which focus on improving strength and balance to reduce fall risk, are generally safe with minimal side effects. However, potential side effects can include muscle soreness, fatigue, and, in rare cases, minor injuries such as strains or sprains. Other common treatments for hip fractures, such as surgical interventions, may have more significant side effects, including infection, blood clots, and complications related to anesthesia. Overall, exercise programs are a low-risk option with benefits that often outweigh the minor potential side effects.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for osteoporosis, which indirectly help in reducing the risk of hip fractures by improving bone density. These include bisphosphonates like alendronate and zoledronic acid, as well as anabolic agents like teriparatide. While these medications are crucial for bone health, non-pharmacologic interventions such as the Otago Exercise Program, which focuses on strength and balance training, are also essential. These exercise programs are designed to reduce fall risk, thereby preventing hip fractures, especially in older adults with mild cognitive impairment. Although specific FDA approvals for exercise programs are not applicable, these interventions are widely recommended in clinical practice guidelines.

What other types of research exist?

Promising alternatives to the Otago Exercise Program for hip fracture patients include multi-component exercise programs that combine weight-bearing exercises, gait training, and balance exercises. Additionally, supervised exercise therapy, which has shown efficacy in improving physical capacity and reducing fall risk, and home-based exercise programs tailored to individual needs are also promising. These alternatives are supported by recent studies and clinical trials.

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Otago Exercise Program for Fall Risk Reduction After Hip Fracture

N/A

Waitlist Available

Led By Larry Dian, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 month and 6 months

Awards & highlights

Summary

This trial tests if doing specific exercises at home can help older adults with mild cognitive issues who have broken their hip from a fall. The goal is to see if these exercises can make them stronger and better at balancing to prevent future falls.

Who is the study for?

This trial is for adults aged 65 or older who have had a fall-related hip fracture within the last year, can walk a short distance with or without help, and have mild cognitive issues but no dementia. They must be able to communicate in English and not be on certain dementia medications.

What is being tested?

The study tests if the Otago Exercise Program (a home-based exercise routine) is better than usual care at reducing the risk of falls among older adults with mild cognitive impairment after they've suffered a hip fracture.

What are the potential side effects?

Since this trial involves an exercise program, potential side effects may include muscle soreness, fatigue, and increased risk of falling during exercises. Usual care typically has minimal side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 month and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 month and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 month and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Activities Specific Balance Confidence

Mental Depression

Trigger Finger Disorder

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Usual Care with ExerciseExperimental Treatment2 Interventions

Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. In addition, they will receive the Otago Exercise Program, an individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist.

Group II: Usual CareActive Control1 Intervention

Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Otago Exercise Program

2022

N/A

~440

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for hip fractures, particularly those similar to the Otago Exercise Program, focus on improving muscle strength and balance to reduce the risk of falls. These treatments typically involve resistance training and balance exercises, which enhance lower extremity strength and proprioception. This is crucial for hip fracture patients, as increased muscle strength and better balance can significantly reduce the likelihood of subsequent falls, thereby preventing further fractures. For patients with cognitive impairments, these exercises are particularly beneficial as they help mitigate the increased fall risk associated with cognitive decline, ultimately aiding in the restoration of function and independence.

Effects of mind-body exercises for osteoporosis in older adults: Protocol for systematic review and Bayesian network meta-analysis of randomized controlled trials.Prescribing Physical Activity for the Prevention and Treatment of Osteoporosis in Older Adults.

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Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,451 Previous Clinical Trials

2,483,130 Total Patients Enrolled

3 Trials studying Hip Fracture

430 Patients Enrolled for Hip Fracture

AmgenIndustry Sponsor

1,420 Previous Clinical Trials

1,382,890 Total Patients Enrolled

Larry Dian, MDPrincipal InvestigatorUniversity of British Columbia

1 Previous Clinical Trials

344 Total Patients Enrolled

Media Library

Otago Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT04748354 — N/A

Hip Fracture Clinical Trial 2023: Otago Exercise Program Highlights & Side Effects. Trial Name: NCT04748354 — N/A

Otago Exercise Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04748354 — N/A

Hip Fracture Research Study Groups: Usual Care, Usual Care with Exercise

~14 spots leftby Sep 2025

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