Working to Increase Stability Through Exercise

NCT02714257 | Completed Results

• 2 other identifiers: IRB-3576PCS-1406-18325-EXT
• Study Type: interventional
• Target: 1,139
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)

  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.

  36 months

Secondary Outcomes (8)

• Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)

  36 months

• Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)

  36 months

• Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)

  36 months

• Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)

  36 months

• Assessment of Physical Function Using PROMIS

  36 months

Study Arms (2)

Enhanced Usual Care - control group

NO INTERVENTION

Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.

Enhanced Usual Care plus Exercise Coaching Intervention

EXPERIMENTAL

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.

Behavioral: Enhanced Usual Care plus Exercise Coaching

Interventions

Enhanced Usual Care plus Exercise Coaching BEHAVIORAL

For month one of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise Digital Versatile Disc (DVDs) every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.

Enhanced Usual Care plus Exercise Coaching Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Pittsburgh: collaborator
• Temple University: collaborator
• Johns Hopkins University: collaborator
• Columbia University: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Christopher Sciamanna, MD, MPH
• Organization: Milton S. Hershey Medical Center

csciamanna@pennstatehealth.psu.edu

717-531-4417

Study Officials

• Christopher Sciamanna, MD, MPH

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Medicine and Public Health Sciences, Division Chief Population Health Research and Development

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 21, 2016
• Study Start: November 21, 2016
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)