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COMPLETED

NCT02714257

Working to Increase Stability Through Exercise

Sponsor: Milton S. Hershey Medical Center

View on ClinicalTrials.gov

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.

Official title: Comparing Two Ways to Reduce Future Fall Injuries Among Older Adults Who Have Fallen - The WISE Study

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1139

Start Date

2016-11-21

Completion Date

2021-12-17

Last Updated

2026-05-07

Healthy Volunteers

Yes

Conditions

Fractures, Bone Serious Fall-related Injuries

Interventions

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.

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.

Locations (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States