Clinical trial NCT02714257: Working to Increase Stability Through Exercise
Official title: Integrating Patient-Centered Exercise Coaching Into Primary Care to Reduce Fragility Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Bone
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Pittsburgh
name: Temple University
name: Johns Hopkins University
name: Columbia University
name: University of Illinois at Chicago
First posted: 2016-03-21
Enrollment: 1139
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 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 1130 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.

\*Due to the COVID-19 pandemic, the in-person intervention was stopped in March of 2020 and a Zoom-based virtual intervention was introduced in April of 2020. Participants that join the zoom-based virtual intervention are lead by staffed exercise coaches.

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.

Primary outcomes:
measure: Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)
timeFrame: 36 months
Secondary outcomes:
measure: Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)
timeFrame: 36 months
measure: Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 36 months
measure: Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)
timeFrame: 36 months
measure: Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)
timeFrame: 36 months
measure: Assessment of Physical Function Using PROMIS
timeFrame: 36 months
measure: Assessment of Depression Using PROMIS
timeFrame: 36 months
measure: Assessment of Anxiety Using PROMIS
timeFrame: 36 months
measure: Assessment of Loneliness Using PROMIS
timeFrame: 36 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Christopher Sciamanna, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: