Working to Increase Stability Through Exercise

Fractures, Bone Clinical Trial

— WISE  

Official title:

Integrating Patient-Centered Exercise Coaching Into Primary Care to Reduce Fragility Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714257
• Other study ID #: IRB-3576
• Secondary ID: PCS-1406-18325-E
• Status: Completed
• Phase: N/A
• Start date: November 21, 2016
• Est. completion date: December 17, 2021

Study information

• Verified date: January 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1139
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone

Intervention

Behavioral:
• Enhanced 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.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Columbia University, Johns Hopkins University, Patient-Centered Outcomes Research Institute, Temple University, University of Illinois at Chicago, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	36 months
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.	36 months
Secondary	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.	36 months
Secondary	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).	36 months
Secondary	Blood Pressure	Blood pressure will be measured by a research assistant using an automatic blood pressure monitor (Omron) and standard procedures.	36 months
Secondary	Body weight	Body weight will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc)	36 months
Secondary	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	36 months
Secondary	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	36 months
Secondary	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.	36 months
Secondary	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).	36 months
Secondary	Assessment of cognitive impairment using the Six-item Callahan screener	Six-item screener will be used to identify cognitive impairment (6 questions total)	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
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.	36 months
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.	36 months
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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	Height	Height will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc)	36 months
Secondary	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.	36 months
Secondary	Assessment of Monitoring devices use.	1 question related to the use of medical alert systems or personal emergency button use.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	Assessment of Home care services	The investigators will ask 3 questions about use of home care services	36 months
Secondary	Assessment of Transportations	The investigators will ask 1 question about ways of transportation the participant use.	36 months
Secondary	Assessment Health insurance use	The investigators will ask 3 question about type of health insurance use	36 months
Secondary	Tobacco Use	The investigators will ask 2 questions about tobacco use.	36 months
Secondary	Education status	The investigators will ask 1 questions about education status.	36 months
Secondary	Socioeconomic status	The investigators will ask 2 questions about socioeconomic status.	36 months
Secondary	Self-reported osteoporosis diagnosis	The investigators will ask 2 questions about osteoporosis diagnosis.	36 months
Secondary	Date of Birth collection	The investigators will ask participants their date of birth (month/date/year)	36 month
Secondary	Number of participants by gender	The investigator will ask if the participant is a male or female	36 months
Secondary	Number of participants by Marital status	The investigators will ask 1 question about marital status.	36 months
Secondary	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	36 months
Secondary	Number of participants by ethnicity	The investigators will ask participants if they are Hispanic or Latino.	36 months