Status:
COMPLETED
Working to Increase Stability Through Exercise
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
University of Pittsburgh
Conditions:
Fractures, Bone
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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 Fragility...
Detailed Description
The intervention will be held in churches, community centers, and senior residential facilities. Investigators will work with the exercise sites to recruit up to 125 individuals (5 per exercise site l...
Eligibility Criteria
Inclusion
- ≥ 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
1139 Patients enrolled
Trial Details
Trial ID
NCT02714257
Start Date
November 21 2016
End Date
December 17 2021
Last Update
February 5 2025
Active Locations (1)
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1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033