Working to Increase Stability Through Exercise

Completed · Not applicable

Conditions studied: Fractures, Bone, Serious Fall-related Injuries

In brief

The investigators propose a 36-month multi-center randomized effectiveness trial to compare the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching (Exercise), on Serious Fall-Related Injuries (SFI) in patients with a previous fragility fracture (FF). The investigators will also examine the impact of the intervention on several secondary outcomes like: loneliness, physical function, and bone strength. The investigators will do this by following a Pragmatic trial design: 1) limiting exclusions to increase representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting measures to those practicable for use in usual care.

Key facts

Study ID

NCT02714257

Run by

Milton S. Hershey Medical Center

People needed

1139

Starts

2016-11-21

Expected to finish

2021-12-17

Last updated by the study team

2026-05-07

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 65 years old
• Previous Fragility Fracture (FF) in past 10 years.
• Able to speak and understand English.
• Participants will need to be willing to try exercising and agree to annual follow-up measurements.

You may not qualify if…

• If the answer to the following questions are "yes", the investigators will exclude the participant from the study Do you feel pain in your chest, neck, jaw, or arms at rest, during your daily activities of living, OR when you do physical activity? Have you ever been told by a health professional that you should not exercise OR exercise only when supervised by a professional?
• If the answer to the following questions are "yes", the investigators will contact physician for permission Do you experience unpleasant awareness of a forceful or rapid heart rate? Do you experience unreasonable breathlessness? Do you experience dizziness fainting or blackouts? Do you experience ankle swelling? Do you have burning or cramping sensation on your lower legs when walking short distances? Do you have diabetes?
• Has a doctor, nurse or health professional ever told you that you had any of the following? Weak or failing kidneys? A heart attack, also called a myocardial infarction? Angina or coronary heart disease? A stroke? Any kind of heart condition or heart disease other than the ones I just asked about?
• Unable to obtain primary care provider consent (if required based on questions above)
• If the participant answer "NO" to the following question: Is it ok if the investigators contact your primary care provider?
• If the participant answer "YES" to the following question:Have you been hospitalized for psychiatric problem in past year?
• If the participant is planning on moving out of the area in the next 36 months
• If currently participates in the Band Together exercise program
• Positive Callahan cognition screener: If participant fails 2 questions, research coordinator will explain study in detail and ask read-back questions. The participant will be excluded if failed read-back.

Where it is running

• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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