Fractures, BoneWISENCT02714257
Working to Increase Stability Through Exercise
A study of Fractures, Bone and Serious Fall-related Injuries, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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 Serious Fall-Related Injuries (SFI) in patients with a previous fragility fracture (FF). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fractures, Bone, Serious Fall-related Injuries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,139 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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?
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Comparing Two Ways to Reduce Future Fall Injuries Among Older Adults Who Have Fallen - The WISE Study
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 Serious Fall-Related Injuries (SFI) 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.
Read the 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, 2020 and a Zoom-based virtual intervention was introduced in April, 2020. Participants that join the Zoom-based virtual intervention are led by staffed exercise coaches.
- Conditions
- Fractures, Bone, Serious Fall-related Injuries
- Being tested
- Enhanced Usual Care plus Exercise Coaching
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Care plus Exercise CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) rregular progress reports sent by coaches to primary care providers via fax/electronic health records every 6 months, to communicate the patient's progress. Receives: Behavioral: Enhanced Usual Care plus Exercise Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing a Serious Fall-Related Injury (SFI)
Every 4 months the investigators will call the participants asking questions about the main outcome, SFI, defined as an injury which required medical care (e.g., fragility fractures, concussion). 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 prior 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.
Measured: 36 months
Secondary outcomes (8)
Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)
The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.
Measured: 36 months
Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)
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.
Measured: 36 months
Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)
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.
Measured: 36 months
Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)
The investigators will use 3 questions from the NHIS at baseline and 36-month follow-up to measure participants' activity level. The percentage of participants meeting guidelines to achieve >=150 minutes/week of moderate and vigorous physical activity and >=2 times/week of strength training is reported.
Measured: 36 months
Assessment of Physical Function Using PROMIS
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.
Measured: 36 months
Assessment of Depression Using PROMIS
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.
Measured: 36 months
Assessment of Anxiety Using PROMIS
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.
Measured: 36 months
UCLA Brief Loneliness Scale
The investigators will use 3 loneliness questions to assess key patient centered outcomes that the intervention may improve. These questions are from the UCLA Brief Loneliness Scale.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start21 Nov 2016
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Pittsburgh, Temple University, Johns Hopkins University, Columbia University, University of Illinois at Chicago
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Christopher Sciamanna, MD, MPH, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714257
- Sponsor's protocol ID
- IRB-3576
- Other IDs
- PCS-1406-18325-EXT
- Acronym
- WISE
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2016
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Ways to Reduce Future Fall Injuries Among Older Adults Who Have Fallen - The WISE Study
- ClinicalTrials.gov ID
- NCT02714257
- Acronym / sponsor ID
- WISE / IRB-3576
- Conditions
- Fractures, Bone, Serious Fall-related Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,139 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Pittsburgh, Temple University, Johns Hopkins University, Columbia University, University of Illinois at Chicago
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Serious Fall-Related Injuries (SFI) 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, 2020 and a Zoom-based virtual intervention was introduced in April, 2020. Participants that join the Zoom-based virtual intervention are led by staffed exercise coaches.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Enhanced Usual Care plus Exercise CoachingParticipants 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) rregular progress reports sent by coaches to primary care providers via fax/electronic health records every 6 months, to communicate the patient's progress. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (9 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Usual Care plus Exercise CoachingFor 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. | Behavioural | Enhanced Usual Care plus Exercise Coaching Intervention |
Primary outcome
Number of Participants Experiencing a Serious Fall-Related Injury (SFI)
Time frame: 36 months
Every 4 months the investigators will call the participants asking questions about the main outcome, SFI, defined as an injury which required medical care (e.g., fragility fractures, concussion). 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 prior 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.
8 secondary outcomes
Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: 36 months
Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 36 months
Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)
Time frame: 36 months
Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)
Time frame: 36 months
Assessment of Physical Function Using PROMIS
Time frame: 36 months
Assessment of Depression Using PROMIS
Time frame: 36 months
Assessment of Anxiety Using PROMIS
Time frame: 36 months
UCLA Brief Loneliness Scale
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Sciamanna, MD, MPH principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fractures, Bone and Serious Fall-related Injuries, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing a Serious Fall-Related Injury (SFI) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.