Working to Increase Stability Through Exercise



Status:Active, not recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:65 - Any
Updated:3/1/2019
Start Date:September 2016
End Date:December 2021

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Integrating Patient-Centered Exercise Coaching Into Primary Care to Reduce Fragility Fracture

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 Fractures and Serious Fall-Related Injuries (FF/SFRI) 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.

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 location) to serve as the Group leaders at each site location. Group
leaders will be trained on the exercises and leadership roles to help lead the group. The
investigators will ask them to come at least once per week, so the time commitment is
minimal.

The investigators will be recruiting 2100 patients who have suffered a fragility fracture and
will randomly assign them to one of two conditions: (A) Control Group - Enhanced Usual Care
and (B) Intervention Group - Enhanced usual care plus Exercise coaching that includes
in-person and phone coach contacts to encourage and support strength, balance and walking
activities.

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.
We found this trial at
1
site
Hershey, Pennsylvania 17033
Principal Investigator: Christopher Sciamanna, MD, MPH
Phone: 717-531-7754
?
mi
from
Hershey, PA
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