Fractures, Bone, Serious Fall-related Injuries
Conditions
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 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.
Interventions
BEHAVIORALEnhanced Usual Care plus Exercise Coaching
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.
Sponsors
Milton S. Hershey Medical Center
Patient-Centered Outcomes Research Institute
University of Pittsburgh
Temple University
Johns Hopkins University
Columbia University
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing a Serious Fall-Related Injury (SFI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| UCLA Brief Loneliness Scale | 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 UCLA Brief Loneliness Scale. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Sciamanna, MD, MPH
Milton S. Hershey Medical Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Usual Care - Control Group 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. | 569 |
| Enhanced Usual Care Plus Exercise Coaching Intervention Participants will receive the 3 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.
Enhanced Usual Care plus Exercise Coaching: For month 1 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 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. | 570 |
| Total | 1,139 |
Baseline characteristics
| Characteristic | Enhanced Usual Care - Control Group | Enhanced Usual Care Plus Exercise Coaching Intervention | Total |
|---|---|---|---|
| Age, Continuous | 73.2 years STANDARD_DEVIATION 6.6 | 73.2 years STANDARD_DEVIATION 6.3 | 73.2 years STANDARD_DEVIATION 6.4 |
| Any fall in past year Missing | 15 Participants | 18 Participants | 33 Participants |
| Any fall in past year No | 283 Participants | 262 Participants | 545 Participants |
| Any fall in past year Yes | 271 Participants | 290 Participants | 561 Participants |
| Body Mass Index (BMI) | 28.6 kg/m^2 STANDARD_DEVIATION 6.5 | 28.6 kg/m^2 STANDARD_DEVIATION 6.5 | 28.6 kg/m^2 STANDARD_DEVIATION 6.5 |
| Education Level College, 1-3 years | 155 Participants | 146 Participants | 301 Participants |
| Education Level College, 4 or more years | 291 Participants | 323 Participants | 614 Participants |
| Education Level Less than high school | 112 Participants | 92 Participants | 204 Participants |
| Education Level Missing | 11 Participants | 9 Participants | 20 Participants |
| History of Osteoporosis Missing | 13 Participants | 8 Participants | 21 Participants |
| History of Osteoporosis No | 295 Participants | 292 Participants | 587 Participants |
| History of Osteoporosis Yes | 261 Participants | 270 Participants | 531 Participants |
| Marital Status Divorced/Separated | 104 Participants | 86 Participants | 190 Participants |
| Marital Status Married/Living with partner | 295 Participants | 299 Participants | 594 Participants |
| Marital Status Missing | 14 Participants | 13 Participants | 27 Participants |
| Marital Status Never married | 34 Participants | 55 Participants | 89 Participants |
| Marital Status Widowed | 122 Participants | 117 Participants | 239 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African-American | 28 Participants | 41 Participants | 69 Participants |
| Race/Ethnicity, Customized Missing | 14 Participants | 10 Participants | 24 Participants |
| Race/Ethnicity, Customized More than One Race | 4 Participants | 8 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 517 Participants | 508 Participants | 1025 Participants |
| Region of Enrollment United States | 569 participants | 570 participants | 1139 participants |
| Sex: Female, Male Female | 479 Participants | 482 Participants | 961 Participants |
| Sex: Female, Male Male | 90 Participants | 88 Participants | 178 Participants |
| Systolic Blood Pressure | 129.7 mmHg STANDARD_DEVIATION 17.7 | 129.4 mmHg STANDARD_DEVIATION 17.8 | 129.5 mmHg STANDARD_DEVIATION 17.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 22 / 569 | 30 / 570 |
| other Total, other adverse events | 0 / 569 | 0 / 570 |
| serious Total, serious adverse events | 162 / 569 | 79 / 570 |
Outcome results
Primary
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.
Time frame: 36 months
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care - Control Group | Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI) | 186 Participants |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI) | 166 Participants |
p-value: 0.4395% CI: [0.74, 1.14]Regression, Cox
Secondary
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.
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care - Control Group | Assessment of Anxiety Using PROMIS | 6.21 score on a scale of 4-20, higher=worse |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Assessment of Anxiety Using PROMIS | 6.07 score on a scale of 4-20, higher=worse |
p-value: 0.2695% CI: [-0.1, 0.38]Mixed Models Analysis
Secondary
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.
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care - Control Group | Assessment of Depression Using PROMIS | 5.62 score on a scale of 4-20, higher=worse |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Assessment of Depression Using PROMIS | 5.52 score on a scale of 4-20, higher=worse |
p-value: 0.3795% CI: [-0.13, 0.34]Mixed Models Analysis
Secondary
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.
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care - Control Group | Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I) | 11.65 score on a scale |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I) | 11.11 score on a scale |
p-value: <0.0195% CI: [0.16, 0.92]Mixed Models Analysis
Secondary
Assessment of Loneliness Using PROMIS
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.
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care - Control Group | Assessment of Loneliness Using PROMIS | 4.19 score on a scale of 3-9, higher=worse |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Assessment of Loneliness Using PROMIS | 4.12 score on a scale of 3-9, higher=worse |
p-value: 0.3995% CI: [-0.09, 0.22]Mixed Models Analysis
Secondary
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.
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care - Control Group | Assessment of Physical Function Using PROMIS | 9.00 Score on a scale |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Assessment of Physical Function Using PROMIS | 8.77 Score on a scale |
p-value: 0.2795% CI: [-0.18, 0.62]Mixed Models Analysis
Secondary
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.
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care - Control Group | Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS) | 0.87 falls |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS) | 0.84 falls |
p-value: 0.595% CI: [0.89, 1.28]Regression, Negative Binomial
Secondary
Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)
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.
Time frame: 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care - Control Group | Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS) | 50.7 Percentage of participants |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS) | 50.9 Percentage of participants |
p-value: 0.7395% CI: [0.85, 1.27]Regression, Logistic
Secondary
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.
Time frame: 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care - Control Group | Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS) | 52.2 Percentage of participants |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS) | 54.3 Percentage of participants |
p-value: 0.395% CI: [0.72, 1.11]Regression, Logistic