Working to Increase Stability Through Exercise

Not Applicable

Completed

Conditions: Fractures, Bone

Interventions: Behavioral: Enhanced Usual Care plus Exercise Coaching

Registration Number: NCT02714257

Lead Sponsor: Milton S. Hershey Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1139

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Usual Care plus Exercise Coaching Intervention	Enhanced Usual Care plus Exercise Coaching	Participants will receive the three printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)	36 months	Every 4 months the investigators will call the participants asking questions about the main outcome, FF/SFI. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 4 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, physical exam notes, dictated radiologist notes and plain film radiography.

Secondary Outcome Measures

Name	Time	Method
Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)	36 months	The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.
Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)	36 months	The investigators will use a self-reported health question to assess key patient centered outcomes that the intervention may improve. This question is from the NIH-supported PROMIS. The outcome is categorized as excellent/very good health vs. good/fair/poor health as reported on the single question.
Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)	36 months	The investigators will use the 7-item version of the Falls Efficacy Scale International (FES-I), used to quantify fear of falling in 7 different scenarios. Each item is scored 1-4, with higher scores being associated with greater fear. Total sum score is reported, possible range 7-28.
Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)	36 months	The investigators will use 6 questions from the NHIS at baseline and the 36 month follow-up to measure participants' activity level. Percentage of participants with a sum of moderate and vigorous minutes \>=150 is reported.
Assessment of Physical Function Using PROMIS	36 months	The investigators will use 4 physical function questions to assess physical function subscale of PROMIS. Each item ranges 1-5. Total sum score is reported; higher scores are associated with lower levels of physical function. Total sum score range, 4-20.
Assessment of Depression Using PROMIS	36 months	The investigators will use 4 depression questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Assessment of Anxiety Using PROMIS	36 months	The investigators will use 4 anxiety questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Assessment of Loneliness Using PROMIS	36 months	The investigators will use 3 loneliness questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.