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Working to Increase Stability Through Exercise (WISE)

Primary Purpose

Fractures, Bone

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Usual Care plus Exercise Coaching
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fractures, Bone

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Enhanced Usual Care - control group

Enhanced Usual Care plus Exercise Coaching Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Assessment of Self-Reported 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.
Assessment of Body composition using Biomedical Impedance Analysis (BIA)
The investigators will use BIA to estimate body composition during baseline and 36-month. It is a noninvasive procedure. BIA measures body fat, and provide an estimate of total body water (TBW). Using values of TBW we will be able to estimate fat-free mass (FFM) and body fat (adiposity).
Blood Pressure
Blood pressure will be measured by a research assistant using an automatic blood pressure monitor (Omron) and standard procedures.
Body weight
Body weight will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc)
Assessment of Fear of Falling using the Falls Efficacy Scale International (FES-I)
The investigators will use the 7-item version of the FES-I
Osteoporosis and Other Medications Questionnaire
At baseline, past osteoporosis medication use and duration will be obtained and, at each assessment time point, patients will be asked for their current list of medications. Medications specific to osteoporosis will be asked for by name (e.g., alendronate). In addition, for each osteoporosis medication, patients will be asked the start date, to estimate duration. The investigators will also search the electronic health record for any use of osteoporosis medications, in case they are not recalled by participants. Other medications will be asked at each time point as well, as certain medications (e.g., benzodiazepines) are known to strongly increase fall risk
Assessment of fuctional lower extremity strengh using the 30 second chair Stand test
At baseline and the 36 month follow-up the participants will perform the 30 seconf chair stand test. This will be used as a measure of functional lower extremity strength.
Assessment of upper strenght using the 30 second arm curl test
At baseline and the 36 months follow-up the participants will perform a 30 second arm curl test. The participants will be asked to use dumbbells (8 lbs for male and 5 lbs for female).
Assessment of cognitive impairment using the Six-item Callahan screener
Six-item screener will be used to identify cognitive impairment (6 questions total)
Assessment of Physical Activity 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. The survey identifies patients that are sedentary, moderately active, or very active.
Assessing caregiver status
The investigators will use two questions from the American Association of Retired People (AARP) Caregiver Identification Study, to identify whether the patient is a caregiver or not.
Number of participants requiring hospitalization
Every 4 months the investigators will call the participants asking questions about hospitalization. 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 3 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.
Number of participants requiring emergency department visits
Every 4 months the investigators will call the participants asking questions about emergency department visit. 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 3 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.
Assessment of Physical Function using PROMIS
The investigators will use 4 physical function questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Assessment of Fatigue using PROMIS
The investigators will use 4 fatigue questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Assessment of Pain using PROMIS
The investigators will use 5 pain questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Assessment of Sleep Disturbance using PROMIS
The investigators will use 4 sleep disturbance questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Assessment of Ability to Participate in Social Roles and Activities using PROMIS
The investigators will use 3 Ability to Participate in Social Roles and Activities questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
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.
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.
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.
Assessment of Bone densitometry using dual energy X-ray absorptiometry (DXA)
For Bone densitometry (BMD), bone mineral content (BMC, g) and bone area (BA, cm2) are measured for the total body, lumbar spine (L1-L4), and total hip (sum of the average femur neck, trochanteric region and proximal femoral shaft from dual-sided measurements). BMD (g m2) is calculated from the BMC and BA.
Assessment of total Body soft tissues using DXA scan
The investigators will measure total body soft tissue in terms of muscle (lean) mass and fat mass.
Assessment of medical history using the Behavioral Risk Factor Surveillance System (BRFSS)
The investigators will assess the prevalence of common chronic conditions (i.e., osteoarthritis, osteoporosis) using questions from the BRFSS.
Height
Height will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc)
Self-reported assessment of Chronic conditions
The investigators will ask 16 questions on chronic conditions, recent healthcare utilization, medical devices, hospital admissions, transportation, health insurance, home care, and nursing home/rehab facility stay.
Assessment of Monitoring devices use.
1 question related to the use of medical alert systems or personal emergency button use.
Assessment of Late-life function using the Late-Life function and disability instrument (LLFDI)
The investigators will ask 10 questions from the LLFDI about function - a person's ability to do discrete actions or activities.
Assessment of Late-life disability using the Late-Life function and disability instrument (LLFDI)
The investigators will ask 10 Questions from the LLFDI about disability-a person's performance of socially defined life tasks.
Assessment of Home care services
The investigators will ask 3 questions about use of home care services
Assessment of Transportations
The investigators will ask 1 question about ways of transportation the participant use.
Assessment Health insurance use
The investigators will ask 3 question about type of health insurance use
Tobacco Use
The investigators will ask 2 questions about tobacco use.
Education status
The investigators will ask 1 questions about education status.
Socioeconomic status
The investigators will ask 2 questions about socioeconomic status.
Self-reported osteoporosis diagnosis
The investigators will ask 2 questions about osteoporosis diagnosis.
Date of Birth collection
The investigators will ask participants their date of birth (month/date/year)
Number of participants by gender
The investigator will ask if the participant is a male or female
Number of participants by Marital status
The investigators will ask 1 question about marital status.
Number of participants by race
The investigators will ask participants if they fall in the following race categories: White Black or African American Asian Native Hawaiian or Other Pacific Islander American Indian or Alaskan Native More than one race Unknown/not reported
Number of participants by ethnicity
The investigators will ask participants if they are Hispanic or Latino.

Full Information

First Posted
February 22, 2016
Last Updated
March 18, 2022
Sponsor
Milton S. Hershey Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, University of Pittsburgh, Temple University, Johns Hopkins University, Columbia University, University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02714257
Brief Title
Working to Increase Stability Through Exercise
Acronym
WISE
Official Title
Integrating Patient-Centered Exercise Coaching Into Primary Care to Reduce Fragility Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, University of Pittsburgh, Temple University, Johns Hopkins University, Columbia University, University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care - control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Enhanced Usual Care plus Exercise Coaching Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care plus Exercise Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)
Description
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
Secondary Outcome Measure Information:
Title
Number of falls and falls-related injuries using the Behavioral Risk Factor Surveillance System (BRFSS)
Description
The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.
Time Frame
36 months
Title
Assessment of Self-Reported Health using the Patient Reported Outcomes Measurement Information System (PROMIS)
Description
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.
Time Frame
36 months
Title
Assessment of Body composition using Biomedical Impedance Analysis (BIA)
Description
The investigators will use BIA to estimate body composition during baseline and 36-month. It is a noninvasive procedure. BIA measures body fat, and provide an estimate of total body water (TBW). Using values of TBW we will be able to estimate fat-free mass (FFM) and body fat (adiposity).
Time Frame
36 months
Title
Blood Pressure
Description
Blood pressure will be measured by a research assistant using an automatic blood pressure monitor (Omron) and standard procedures.
Time Frame
36 months
Title
Body weight
Description
Body weight will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc)
Time Frame
36 months
Title
Assessment of Fear of Falling using the Falls Efficacy Scale International (FES-I)
Description
The investigators will use the 7-item version of the FES-I
Time Frame
36 months
Title
Osteoporosis and Other Medications Questionnaire
Description
At baseline, past osteoporosis medication use and duration will be obtained and, at each assessment time point, patients will be asked for their current list of medications. Medications specific to osteoporosis will be asked for by name (e.g., alendronate). In addition, for each osteoporosis medication, patients will be asked the start date, to estimate duration. The investigators will also search the electronic health record for any use of osteoporosis medications, in case they are not recalled by participants. Other medications will be asked at each time point as well, as certain medications (e.g., benzodiazepines) are known to strongly increase fall risk
Time Frame
36 months
Title
Assessment of fuctional lower extremity strengh using the 30 second chair Stand test
Description
At baseline and the 36 month follow-up the participants will perform the 30 seconf chair stand test. This will be used as a measure of functional lower extremity strength.
Time Frame
36 months
Title
Assessment of upper strenght using the 30 second arm curl test
Description
At baseline and the 36 months follow-up the participants will perform a 30 second arm curl test. The participants will be asked to use dumbbells (8 lbs for male and 5 lbs for female).
Time Frame
36 months
Title
Assessment of cognitive impairment using the Six-item Callahan screener
Description
Six-item screener will be used to identify cognitive impairment (6 questions total)
Time Frame
36 months
Title
Assessment of Physical Activity using the National Health Interview Survey (NHIS)
Description
The investigators will use 6 questions from the NHIS at baseline and the 36 month follow-up to measure participants' activity level. The survey identifies patients that are sedentary, moderately active, or very active.
Time Frame
36 months
Title
Assessing caregiver status
Description
The investigators will use two questions from the American Association of Retired People (AARP) Caregiver Identification Study, to identify whether the patient is a caregiver or not.
Time Frame
36 months
Title
Number of participants requiring hospitalization
Description
Every 4 months the investigators will call the participants asking questions about hospitalization. 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 3 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
Title
Number of participants requiring emergency department visits
Description
Every 4 months the investigators will call the participants asking questions about emergency department visit. 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 3 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
Title
Assessment of Physical Function using PROMIS
Description
The investigators will use 4 physical function questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Time Frame
36 months
Title
Assessment of Fatigue using PROMIS
Description
The investigators will use 4 fatigue questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Time Frame
36 months
Title
Assessment of Pain using PROMIS
Description
The investigators will use 5 pain questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Time Frame
36 months
Title
Assessment of Sleep Disturbance using PROMIS
Description
The investigators will use 4 sleep disturbance questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Time Frame
36 months
Title
Assessment of Ability to Participate in Social Roles and Activities using PROMIS
Description
The investigators will use 3 Ability to Participate in Social Roles and Activities questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Time Frame
36 months
Title
Assessment of Depression using PROMIS
Description
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
Title
Assessment of Anxiety using PROMIS
Description
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
Title
Assessment of Loneliness using PROMIS
Description
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
Title
Assessment of Bone densitometry using dual energy X-ray absorptiometry (DXA)
Description
For Bone densitometry (BMD), bone mineral content (BMC, g) and bone area (BA, cm2) are measured for the total body, lumbar spine (L1-L4), and total hip (sum of the average femur neck, trochanteric region and proximal femoral shaft from dual-sided measurements). BMD (g m2) is calculated from the BMC and BA.
Time Frame
36 months
Title
Assessment of total Body soft tissues using DXA scan
Description
The investigators will measure total body soft tissue in terms of muscle (lean) mass and fat mass.
Time Frame
36 months
Title
Assessment of medical history using the Behavioral Risk Factor Surveillance System (BRFSS)
Description
The investigators will assess the prevalence of common chronic conditions (i.e., osteoarthritis, osteoporosis) using questions from the BRFSS.
Time Frame
36 months
Title
Height
Description
Height will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc)
Time Frame
36 months
Title
Self-reported assessment of Chronic conditions
Description
The investigators will ask 16 questions on chronic conditions, recent healthcare utilization, medical devices, hospital admissions, transportation, health insurance, home care, and nursing home/rehab facility stay.
Time Frame
36 months
Title
Assessment of Monitoring devices use.
Description
1 question related to the use of medical alert systems or personal emergency button use.
Time Frame
36 months
Title
Assessment of Late-life function using the Late-Life function and disability instrument (LLFDI)
Description
The investigators will ask 10 questions from the LLFDI about function - a person's ability to do discrete actions or activities.
Time Frame
36 months
Title
Assessment of Late-life disability using the Late-Life function and disability instrument (LLFDI)
Description
The investigators will ask 10 Questions from the LLFDI about disability-a person's performance of socially defined life tasks.
Time Frame
36 months
Title
Assessment of Home care services
Description
The investigators will ask 3 questions about use of home care services
Time Frame
36 months
Title
Assessment of Transportations
Description
The investigators will ask 1 question about ways of transportation the participant use.
Time Frame
36 months
Title
Assessment Health insurance use
Description
The investigators will ask 3 question about type of health insurance use
Time Frame
36 months
Title
Tobacco Use
Description
The investigators will ask 2 questions about tobacco use.
Time Frame
36 months
Title
Education status
Description
The investigators will ask 1 questions about education status.
Time Frame
36 months
Title
Socioeconomic status
Description
The investigators will ask 2 questions about socioeconomic status.
Time Frame
36 months
Title
Self-reported osteoporosis diagnosis
Description
The investigators will ask 2 questions about osteoporosis diagnosis.
Time Frame
36 months
Title
Date of Birth collection
Description
The investigators will ask participants their date of birth (month/date/year)
Time Frame
36 month
Title
Number of participants by gender
Description
The investigator will ask if the participant is a male or female
Time Frame
36 months
Title
Number of participants by Marital status
Description
The investigators will ask 1 question about marital status.
Time Frame
36 months
Title
Number of participants by race
Description
The investigators will ask participants if they fall in the following race categories: White Black or African American Asian Native Hawaiian or Other Pacific Islander American Indian or Alaskan Native More than one race Unknown/not reported
Time Frame
36 months
Title
Number of participants by ethnicity
Description
The investigators will ask participants if they are Hispanic or Latino.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Sciamanna, MD, MPH
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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