Project Summary

PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Regular exercise can help older adults stay fit and avoid bone fractures. But many older adults don’t get enough exercise to stay fit and strong. After older adults fall and fracture a bone, they are less likely to exercise. Not exercising increases people’s risk of falling and makes them more likely to fracture another bone in the future.

This study compares two ways of reducing bone fractures and serious injuries among adults ages 65 and older who have previously fallen and fractured a bone:

  • Normal follow-up care plus information about falls and exercise: In normal follow-up care, patients get treatment for their fracture and the medical conditions that may have caused their falls. They also get a screening for osteoporosis, treatment for osteoporosis if needed, and physical therapy and education about preventing falls.
  • Normal follow-up care plus an exercise coaching program developed with patient input. The coaching program focuses on how to exercise safely.

Who can this research help?

This research can help older patients who are at risk for falling or who want to learn how to exercise safely. It can also help doctors who want to find out how to prevent falls and fractures in older people. This research can also help health insurance companies and Medicare make evidence-based coverage decisions about exercise coaching programs.

What is the research team doing?

The research team is working with 2,100 older adults who have fractured a bone. The team is assigning these adults to one of two groups by chance. Adults in both groups get normal follow-up care as well as pamphlets about preventing falls and injuries. Adults in the second group also take part in an exercise coaching program. In this program, a trained exercise coach helps people learn how to complete strength, balance, and aerobic exercises (such as walking) safely. The coach encourages patients to exercise with a group in local community centers, churches, and senior residential facilities. Patients can also exercise at home and get telephone support from the exercise coach. The exercise coach sends regular reports about patients’ progress to each patient’s doctor.

Every four months over the course of three years, the researchers follow up to find out if people have

  • Fallen
  • Fractured a bone after falling
  • Had a serious injury after falling
  • Been admitted to a hospital, nursing home, or other rehabilitation facility

The research team is working with patients who volunteer as peer leaders in the exercise coaching program. The team is also working with a company called Health Dialog to develop the exercise coaching program. Representatives from health departments, medical societies, and insurance companies assist with study design and recruit patients to the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population Adults ages 65 and older who have fallen and fractured a bone within the past five years
Interventions/
Comparators
  • Usual care
  • Usual care plus an exercise coaching program
Outcomes

Primary: fractures from weak bones, fall-related injuries

Secondary: muscle strength, bone strength, loneliness, depression, use of emergency medical care

Timeframe 3-year follow-up for primary outcomes

Engagement Resources

Project Information

Christopher Sciamanna, MD, MPH
Pennsylvania State University Hershey Medical Center
$13,871,208
Integrating Patient-Centered Exercise Coaching into Primary Care to Reduce Fragility Fracture

Key Dates

April 2015
January 2023
2015

Study Registration Information

Tags

Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022