Working to Increase Stability Through Exercise
Fractures, Bone · Serious Fall-related Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02714257 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Usual Care plus Exercise Coaching (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing a Serious Fall-Related Injury (SFI) |
186; 166 | 0.43 |
| SECONDARY Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS) |
0.87; 0.84 | 0.50 |
| SECONDARY Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS) |
52.2; 54.3 | 0.30 |
| SECONDARY Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I) |
11.65; 11.11 | <0.01 sig |
| SECONDARY Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS) |
50.7; 50.9 | 0.73 |
| SECONDARY Assessment of Physical Function Using PROMIS |
9.00; 8.77 | 0.27 |
| SECONDARY Assessment of Depression Using PROMIS |
5.62; 5.52 | 0.37 |
| SECONDARY Assessment of Anxiety Using PROMIS |
6.21; 6.07 | 0.26 |
| SECONDARY UCLA Brief Loneliness Scale |
4.19; 4.12 | 0.39 |
Summary
Eligibility Criteria
Inclusion Criteria
- ≥ 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 Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02714257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.